Scancell Holdings PLC (PK) (SCNLF) News

Moditope eradicates aggressive melanoma in transgenic mice

07 May 2014 | by mutatis mutandis

Moditope is a brand new immunotherapy. Scancell announcing its discovery in August 2012 explained that they had discovered a series of modified chemicals found only in cancer that stimulated the production of a very rare cancer killing immune cell called a killer CD4 T cell. Appearing infrequently and fleetingly in nature, Scancell was now able to utilize, and at the same time offer vaccine developers, a practical and convenient method to generate huge quantities of these rare cancer killing cells in cancer patients. Killer CD4 cells have a far greater potency than the killer CD8 cells that scientists currently stimulate in cancer patients with today's vaccines. Also because of their rarity cancer has been unable to evolve any means to protect itself against them.

Following their discovery the Scancell team followed a rigorous regime of testing to explore the efficacy of Moditope. First they tested to see if Moditope could generate an immune response in humans to show that its modified chemicals could cause the immune system to reject cancer. This was done by extracting blood cells from cancer patients and testing a Moditope vaccine on these cells which promptly produced large quantities of the human immune substances Gamma Interferon and Interleukin-17, showing a powerful immune response had taken place. The response was far more powerful than Scancell had seen before.

Then Scancell tested Moditope on humanized transgenic mice that had developed solid tumors. These mice were bred from the offspring of a female mouse that had received an implanted fertilized egg cell in her womb that incorporated a single human gene. This gene, called HLA-DR4, eliminated the possibility of differences in the way these mice presented Moditope to their immune systems. In other words vital elements of their immune systems were identical to those found in humans.

Scancell initiated tests by giving these 'humanized mice' a notoriously aggressive and difficult to treat form of melanoma called B16. Then after waiting 4, sometimes 7 and sometimes 10 days they selected those which had developed spreading tumors and immunized half with Moditope and left the remainder untreated. Astonishingly all tumors were eradicated completely in between 70 to 90 per cent of immunized mice. After 38 days all the untreated animals were dead but up to 85 per cent of those which had received the vaccine were still alive. The death of all the untreated mice is a testament of just how aggressive this particular tumor model is. In fact by day 14 the tumors of some of the untreated mice were so large the law required them to be culled for ethical reasons. So the up to 90 per cent eradication of all tumors in the immunized mice and an average of 85 percent overall survival was truly amazing, prompting Professor Durrant, Scancell's CEO, to comment: "I have never seen anything quite so profound as this in this aggressive tumor model."

As a special note, in a separate experiment which tested Moditope at the very limits of what is legally acceptable some of these mice only received the vaccine on day 14. Bearing in mind that a tumor response takes 7 days, that is it won't start working until day 21, 40 per cent of these late treated mice still saw a total eradication of their horrendously large tumors. Of course with human patients it would be very rare indeed to be treated at such an unacceptably late stage. Nevertheless this additional data is an important indication of the sheer power of Scancell's discovery.

The company maintains that Moditope can produce vaccines to treat all types of cancer. Indeed Scancell has recently employed more scientists with the intention of generating more Moditope vaccines. The object being to seek licensing partners and thereby generate revenue for the company going forward. Meanwhile Scancell is pressing ahead with their first in-house Moditope vaccine to treat triple-negative breast, cervical and womb cancer which is expected to enter human trials in early 2016.


Euro Investor

Scancell to give AACR presentation on SCIB1 vaccine

This post has been copied from Stock Oracle's SCNLF board at HotStockMarket:

Scancell is to present interim data on their SCIB1 vaccine at this month's Annual Meeting of the American Association for Cancer Research (AACR), held in San Diego. The event kicks off tomorrow and runs until April 9th. Scancell will give their presentation on Tuesday, Apr 8th, between 1:35 PM - 1:50 PM.

AACR is the premier cancer research event with about 18,000 researchers, patient advocates, and other professionals in the cancer field from around the world scheduled to be in attendance. It provides a unique opportunity for members of the worldwide cancer research community to learn about cutting-edge advances, obtain feedback on their own research, and make connections that will foster future collaborations.

Comment by the British blogger Shri9:
"If you follow the industry news on a regular basis you can't fail to read how Scancell''s American competitors enthuse on their websites and in the press that they are to present their trial results at the AACR Annual Meeting. This appears to be a must that so many European and overseas companies get excluded from. Scancell's invitation to present their SCIB1 vaccine's trial results at the AACR ensures a level playing field with regard to the company's promotion in the world's most important oncology market. It is also an important reminder that one of Scancell's most important collaborators on their SCIB1 vaccine is the United States government whose Institutes of Health is to receive royalty payments when the vaccine enters production. Earlier this year the U S Food and Drug Administration (FDA) granted orphan drug designation to SCIB1 qualifying the vaccine for a 50% tax credit for clinical trials, a waiver of the prescription drug user fee for the drug approval procedure and at least seven-year market exclusivity following drug approval by the FDA."

Here is a link to an abstract of the upcoming presentation:
Presentation Abstract

The CEO has said that the first deal he expects to make is for a product from Scancell's Moditope platform. He also said on Investor Day that he doesn't intend to wait for any further development of Moditope before doing a deal.

If you listen to the Webconference posted on Scancell's website he also says about Moditope - "We're getting already significant interest from pharmaceutical companies, even at this early stage and with this particular platform we think its realistic to expect to do some licensing deals in the short to medium term."

Then there is the Sunday Times article where the CEO says the following about what he expects to follow with SCIB1 after publishing encouraging data last month - “We are looking at 2014 as the year we consummate a relationship or a deal to take this forward.”

(borrowed from LSE)


I don't think we'll have to wait long for those things to materialize. As soon as we get a licencing deal the share price will undoubtedly reflect that. Note that with Moditope patent application published, Scancell can now do licencing deals on both platforms (Immunobody and on Moditope).
It's also interesting to note that Inovio had a similar mcap before their deal with Roche, and has grown 800% since. You have a rare opportunity here to buy into a similar company before a deal is struck, which is pretty much guaranteed to happen BTW. And if you look at Scancell's results you'll see that they are significantly better than those of Inovio.

I've been long on Scnacell for quite some time, and I've shifted all my funds there, despite promising myself never to be "all in" no mater how good the company looks. It's just one of those opportunities that don't come around very often. I may not find such a safe investment and at the same time a great potential in my lifetime again, so I broke that rule.
Funded till at the very least 2016 with a view to sell the business as soon as possible (I'd guess sometime within the next 2 years). I've met the BOD personally on number of occasions and I sleep well knowing my money is in their hands - just check out their CV's.

Don't be put off by the fact that it's on grays market - this is only a secondary listing to allow Americans and Canadians to buy more easily. The company is primarily listed on the London Stock Exchange.
Scancell's link to London Stock Exchange



Here's a good summary from another poster (from a different board). Worth a read even if you're not interested.
I have his permission to re-post elsewhere.


Scancell does have two cancer vaccine platforms, ImmunoBody and Moditope but both are immunotherapies. Both ImmunoBody and Moditope use cancer epitopes (tiny chemical markers found only in cancer) to immunize the patient against cancer - much like anti-viral vaccines use dead viruses. These tell tale epitopes are given to the immune system like a scent to a bloodhound to enable the immune system's killer T cells to hunt down cancer and destroy it.



IMMUNOBODY

At the moment cancer vaccines use either cancer antigens or the active bits of cancer antigens (epitopes) to generate large quantities of these killer T cells called CD8 T cells. CD8 T cells are found commonly in the human body but never in sufficient numbers to fight off cancer properly. Cancer vaccines give the immune system a big boost by generating large enough quantities of CD8 cells to make an impact on cancerous tissue. They literally eat away at tumours and if the vaccine is powerful enough, such as Scancell's ImmunoBody, the CD8 T cells will eradicate the tumours altogether.

Today's cancer vaccines also generate CD4 T cells which perform the roll of helper immune cells. CD4's help to swell the population of killer CD8's and help to make the environment around the tumour more conducive as a killing zone for CD8 T cells to get stuck in and chemically eat away the tumours with their enzymes. Merciless!

The main difference between Scancell's ImmunoBody vaccines and other anti-cancer vaccines is that they generate far more powerful killer CD8 T cell responses against tumours than any other vaccines in development.



MODITOPE

So we can see that today's cancer vaccines including Scancell's highly potent ImmunoBody vaccines stimulate the immune system to produce killer CD8 T cells to attack cancer and CD4 T cells to perform the roll of helpers to the CD8 cancer killing army. But this status quo has been suddenly altered through a remarkable discovery by Scancell's Prof. Durrant that changes CD4 T cells from helpers to direct cancer killing cells in their own right.

This was done by the discovery of a whole new class of cancer epitopes. These epitopes (unlike those used in ImmunoBody and other cancer vaccines) instead of generating killer CD8 T cells as might have been expected, generate CD4 T cells but not in their normal role as helper cells but as direct cancer killing cells. This change of roll can come about on occasion in nature but only a tiny number have been observed in certain rare diseases states. But what became known as Scancell's Moditope epitopes generated huge expanding populations of these rare killer cells which had the power to eradicate even the largest and most aggressive tumours. Professor Durrant said of this phenomenon that she had never come across such a powerful anti-tumour effect during the whole of her professional career.

Because Scancell's new and patented Moditope epitopes are the only way so far discovered of generating in a vaccine a usable quantity of these uniquely potent cancer killing CD4 T cells the company intends to offer Moditope via out-licensing to other vaccine companies and government agencies as well as developing Moditope vaccines themselves.



SOME KEY DIFFERENCES BETWEEN THE IMMUNOBODY AND MODITOPE VACCINES SCANCELL HAS UNDER DEVELOPMENT:

Apart from the fact that these two vaccine platforms generate two different kinds of killer T cells to fight off cancer (cytolytic [or cytotoxic] CD8 and cytolytic CD4 cells respectively) Scancell has also decided to deploy these two vaccine platforms in different ways.

ImmunoBody is currently being administered as a DNA biological program, that is, a form of biological software. This program is incorporated into a vaccine in the form of microscopic rings of DNA originally written and sequenced by Scancell's scientists. These tiny rings of DNA are then injected into immune cells beneath the skin while applying a weak electric current which opens the pores of these immune cells to admit the DNA.

The cells known as antigen presenting cells 'read' the DNA instructions and start to produce proteins and mini-proteins called peptides to Scancell's specific design. Y shape proteins are produced with peptides in the form of mimics of cancer epitopes fused to the arms of the Y: all manufactured from chemicals in these immune cells to Scancell's strict DNA instructions.

These cells then migrate to the lymph nodes to present the cancer epitope mimics either to CD8 cancer killing T cells or their CD4 helpers. The cancer killing CD8 cells are then able to sniff out the cancer and mount an attack against it.

Moditope epitopes can be used like this (by being produced by immune cells through programming with DNA) but Scancell has decided in its first Moditope vaccine to produce quantities of these especially modified Moditope epitopes in culture outside the patient and introduce them directly to the immune system by a process known as endogeny which I shall explain below. The Moditope epitopes being fragments of proteins are classified as peptides. Peptides are really mini-proteins which consist of only a few units rather than the hundreds of units that complete proteins such as cancer antigens consist of. Which is why this type of vaccine containing raw biological epitopes when attached to a carrier protein is called a peptide vaccine.

The carrier protein used tends to be something entirely alien to the immune system such as a protein extracted from a sea creature. This alien combo is enough to provoke immune cells to engulf it (endogeny) and after breaking it down, end up presenting the Moditope epitopes to the rare and super powerful cancer killing CD4 T cells which are unique to the Moditope discovery.

Both ImmunoBody and Moditope can be used in either DNA vaccines or in peptide vaccines. The Y shaped ImmunoBody molecules that carry cancer epitopes on their arms can be manufactured outside the body and introduced to the patient as a peptide vaccine. Likewise, as previously mentioned, the Moditope epitopes can be programmed for by a DNA vaccine and produced by antigen presenting cells for presentation to the ultra potent killer C4 T cells. Currently Scancell has no plans to produce an ImmunoBody peptide vaccine or conversely a Moditope DNA vaccine.




CANCERS CURRENTLY BEING TARGETED BY IMMUNOBODY AND MODITOPE

Scancell's pipeline of ImmunoBody vaccines consist of SCIB1(Scancell[SC] ImmunoBody[IB] -1) to fight the deadly skin cancer metastatic melanoma. There is also SCIB2 to fight lung cancer and a series of others in early development, including one to fight prostate cancer.

SCIB1 is currently in Phase 2 trials and has just been awarded the coveted Orphan Drug Designation by the FDA. The lung cancer vaccine SCIB2 has completed animal studies and is now ready for clinical trials. The company hopes to attract a partner to take this forward.

Scancell's first Moditope vaccine, Modi-1, to treat triple-negative breast, cervical and endometrial cancers is under way and is expected to begin human trials in 2016. The directors are planning to sell the company in the not too distant future so the responsibility of taking Modi-1 forward may fall to whoever buys Scancell.




UNIQUE FEATURES OF SCANCELL'S VACCINE PLATFORMS

I suppose one of the most striking features of ImmunoBody is that it is re-programmable. Indeed it can be rapidly reprogrammed to produce quick fire vaccines to treat any kind of cancer simply by reprogramming for a different cancer epitope to be produced by antigen presenting cells. In other words small alterations in ImmunoBody's DNA code produces a new vaccine to treat a different kind of cancer with considerable ease, or as Scancell says in their Admission to AIM document: "an ImmunoBody® `plug and play' epitope expression vector system has been developed which enables new vaccines to be generated in a matter of weeks."

When it comes to Moditope, all is unique. Scancell's Moditope discovery generates a new kind of super potent cancer killing immune cell known as a killer CD4 T cell. They don't exist in nature in usable quantities and until Moditope was discovered, vaccine scientists had no way of generating them. Moditope has been shown to generate huge quantities of these powerful cancer killers that destroy even the largest and most aggressive tumours without toxicity.

It should also be added that ImmunoBody as well as Moditope can eradicate tumours without toxicity.

Part 1 Dosing Completed In Additional Tumor Trial

I reported last August on Scancell's decision to seek an extension to their Phase I/II trial of their SCIB1 DNA dendritic cell vaccine to treat metastatic melanoma. Part 2 of the original trial was completed last year with the vaccine being given to patients whose tumors had been surgically removed with the intention of generating a strong enough immune response with SCIB1 to prevent recurrence. Results of this originally intended final Part exceeded the directors highest expectations.

But as a result of a finding in the original Part 1, which was a dose escalation study beginning in June 2010 and reporting in December 2012, a decision was made to seek initially an extension to Part 1 and then to Part 2. To the surprise of the researchers the vaccine had the effect of completely eliminating all metastatic tumors in one patient's lungs. This was a patient in one of the higher dose, 4mg, cohorts whose tumors were inoperable.

It is well known that dendritic cell vaccines (the only type of cancer vaccine authorized for use by the FDA) do not as a rule shrink tumors, let alone eliminate them. So following permissions from the United Kingdom's Gene Therapy Advisory Committee ('GTAC') and the Medicines and Healthcare products Regulatory Agency ('MHRA') five patients with metastatic tumors were given SCIB1, at a new higher dose of 8mg as an extension to the original Part 1 study looking at dosage safety as well as immune and clinical responses to the vaccine. The final patient of this new cohort with tumor load has now been dosed. There were no reported serious adverse events. Immunological and clinical responses will be assessed and reported at the end of Q2. Obviously investors will be awaiting this data with bated breath.

We also learn today that Part 2 of this new higher 8mg dose in patients with tumor load has now begun with the first patient receiving their first inoculation of SCIB1 earlier this week. Up to thirteen patients with tumor load will be included in this extended second part.

Here is a useful article reporting today's news:
Scancell completes part 1 dosing for cancer study

Scancell's Moditope patent is published

Click here for article

PATENT FOR NEW MODITOPE VACCINE TECHNOLOGY PUBLISHED

Scancell Holdings PLC
18 Feb 2014 07:00:20

Scancell Hlds

RNS Number : 2822A
Scancell Holdings Plc
18 February 2014



18 February 2014

Scancell Holdings Plc
('Scancell' or the "Company")

Publication of Moditope® Patent

Scancell Holdings Plc, (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce the publication of the patent application underpinning the Company's Moditope® platform. When granted, this patent will protect the platform to at least 2033.

The patent application, describes how the Moditope® immunotherapy platform harnesses CD4+ T cells to eradicate tumours. Moditope® deploys certain tumour-associated peptide epitopes as immunotherapeutic agents to overcome self-tolerance and eradicate tumour cells, with no requirement for blockade inhibitors. Planning is underway for the manufacture, preclinical testing and first-in-man clinical development of the Modi-1, the first Moditope® immunotherapeutic. The PCT patent application which has a priority date of 7 August 2012 was published on 13 February 2014 as WO2014/023957.

Prof. Lindy Durrant Professor of Cancer Immunotherapy at the University of Nottingham and Joint CEO of Scancell, said:

"The publication of the patent application is another important milestone in the development of a range of novel immunotherapeutics from the Moditope® platform. Recent data suggests that Modi-1 may exhibit potent anti-tumour effects even against established aggressive tumours, dramatically improving survival rates. We look forward to a busy and exciting year in which we continue to prepare Modi-1 for clinical trials which are on schedule to start in early 2016."


About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms. Scancell's first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is being evaluated in a Phase 1/2 clinical trial. Data from the trial demonstrate that SCIB1 produced a melanoma-specific immune response and promising survival trend.

Scancell's ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.



This information is provided by RNS, the company news service from the London Stock Exchange

END


London Stock Exchange

Scancell's SCIB1 vaccine granted FDA orphan drug status

Scancell Holdings, the developer of novel immunotherapies for the treatment of cancer, said the US Food and Drug Administration has granted orphan drug designation to its SCIB1 ImmunoBody for the treatment of metastatic melanoma.

Orphan drug status qualifies the development of SCIB1 for a 50% tax credit for clinical trials, a waiver of the prescription drug user fee for the drug approval procedure and a period of seven years of market exclusivity following drug approval by the FDA.

During the orphan market exclusivity period, the FDA cannot approve a NDA (new drug application) or a generic drug application for the same product including the principal molecular structure features of the drug and for the same rare disease indication.


Stock Market Wire

SCANCELL'S SKIN CANCER VACCINE EXCEEDS EXPECTATIONS


RNS Number : 9752U
Scancell Holdings Plc
09 December 2013


9 December 2013


Scancell Holdings Plc

Compelling new immune response data and promising survival trend suggest potential for SCIB1 as an effective novel therapy in metastatic melanoma

Scancell Holdings plc ('Scancell' or the 'Company'), the developer of novel immunotherapies for the treatment of cancer, is pleased to announce encouraging results from Part 2 of its on-going Phase 1/2 clinical trial in patients with Stage III/IV melanoma treated with the SCIB1 ImmunoBodyÒ as well as an update from patients in Part 1 of the study.


Highlights

Part 2 study results
· All 14 study patients produced a melanoma-specific T-cell response to treatment
· All patients are still alive; only three patients have any evidence of disease progression
· Median survival time of Part 2 patients since initiating treatment is currently 15 months; 21 months since diagnosis of metastatic disease
· Six patients are continuing on extended, long-term treatment with SCIB1
· SCIB1 therapy was well tolerated with no reports of serious drug-related side effects in line with results reported from Part 1 of the study

Part 1 study update
· The four patients who were alive at the time of the initial Part 1 report (December 2012) remain alive
· Median survival time in Part 1 patients who received at least three treatments with the 2mg/4mg doses of SCIB1 is now 25 months

These results confirm that Scancell's SCIB1 ImmunoBody® therapy is producing a melanoma-specific immune response in patients with Stage III/IV melanoma. This is particularly evident in patients with resected disease. Together with the immunological and clinical data from Part 1 of the study, the results suggest that these induced immune responses might also be contributing to the control of tumour in these patients.


Prof Lindy Durrant, Joint CEO of Scancell Holdings and Professor of Cancer Immunotherapy at Nottingham University, commented:

"These results exceeded our highest expectations confirming that SCIB1 induces a consistent melanoma-specific immune response in Stage III/IV melanoma patients, especially in those with resected disease. Whilst the numbers are still small, it suggests that SCIB1 may be contributing to prolonged survival by controlling tumour growth and supports our belief that the highly targeted ImmunoBody® approach generates potent and specific T cells that can control malignant disease."


Prof Poulam Patel, the principal investigator in the trial and Prof of Clinical Oncology at the University of Nottingham, added:

"This promising new data further supports our hypothesis that SCIB1 can harness the body's own immune system to control metastatic melanoma in a safe and effective way. More generally it also adds to the growing belief that training T cells to target and control tumour growth is one of the most promising new ways of treating cancer. In patients with more extensive metastases, it is feasible that combining SCIB1 with the latest checkpoint inhibitor drugs, which allow T cells to work better within the tumour environment, may offer further patient benefit."


Study Design

The first part of this single arm, open label, Phase 1/2 clinical trial was conducted in five UK centres in 11 patients, ten with Stage IV and one with Stage III malignant melanoma. Patients were to be given five doses of 0.4mg, 2mg or 4mg of SCIB1, delivered by Ichor Medical Systems' TriGrid™ electroporation delivery device, over a period of sixmonths. One patient in the 0.4mg dose group and one in the 4mg dose group who received only a single dose of SCIB1 were withdrawn from the study due to progressive disease shortly after study entry and were replaced to ensure that at least three patients in each dose cohort could be fully evaluated for immune response. During the course of the study, regulatory approval was granted to increase the SCIB1 dose from 2mg to 4mg in patients in the 2mg cohort, if the treatment was well tolerated. Two patients in this group received two 4mg doses of SCIB1 and onepatient received a single 4mg dose. Regulatory approval was subsequently obtained for treating a cohort of patients with 8mg of drug. Dosing of these patients is currently on-going.

In Part 2 of the study, 14 patients with resected Stage III/IV melanoma (eight with Stage III and six with Stage IV) entered the study. One patient was only able to tolerate three doses of 2mg and withdrew from the study. Of the remaining patients, 12 received a full 4mg dose of SCIB1 on five occasions over a period of 6 months and one received four doses of 4mg and one dose of 2mg.

During the course of the study, regulatory approval was granted to continue treating eligible patients for a period of up to 5 years from the formal end of the study. During this period patients can receive a 4mg dose of SCIB1 every 3-6 months.


Clinical response

Part 1
Four out of the six patients in the 2mg/4mg cohorts who received at least three doses of SCIB1 are still alive and one remains disease-free more than 2 years after starting treatment. All of the patients in the 0.4mg dose group have died from melanoma progression. The median survival time for the six evaluable patients in the 2mg/4mg cohorts is currently 25 months.

One patient in the 4mg dose group with multiple tumour lesions present at the start of treatment showed a "differential response" pattern in which all of her lung lesions decreased in size or disappeared completely following six months of treatment with SCIB1 whereas one abdominal wall tumour nodule grew and was resected. Staining of tissue taken from the resected nodule showed it had lost expression of one of the target melanoma antigens, gp100, but had high levels of PD-1 protein, which is known to attenuate high avidity T cell responses; this suggests that combining SCIB1 treatment with anti-PD-1 monoclonal antibodies may be an effective therapeutic approach. The patient continued on extended treatment with SCIB1 until she was subsequently found to have recurrent melanoma in her intestines; this tumour was also excised and treatment was discontinued.

Part 2
All of the resected Stage III/IV patients treated with SCIB1 in Part 2 remain alive and only three have had progressive disease to date. One patient had their lesion excised in January 2013 and has no further disease progression to date. The other two patients have progressed within the last month. The median survival time for Part 2 patients is currently 15 months from study entry and 21 months from diagnosis of metastatic disease.


Immune response

Immune response was measured by peptide-specific proliferation. A positive response required at least twice the background control at each time point and at least twice the pre-treatment control value on two or more of the six time points measured. In addition, responses were assessed using an enzyme-linked immunosorbent (ELISPOT) assay after T cell expansion in vitro, where a positive response was more than three standard deviations above the pre-treatment control value on two or more of the six time points measured. Fresh samples were analysed in both assays, except for one patient where the controls for the fresh proliferation assay were not validated and the assay was repeated using frozen samples.

Part 1
One patient in the 0.4mg cohort, all three patients in the 2mg/4mg dose cohort and two patients in the 4mg dose cohort mounted a measurable proliferation response to the melanoma-specific epitopes in SCIB1. In addition, the patient with the differential clinical response was assessed using the ELISPOT assay and made a strong response to the melanoma TRP-2 antigen.

Part 2
All 14 patients responded to treatment in either the proliferation or ELISPOT assay. Twelve patients were immune responders in the proliferation assay, 13 patients responded in the ELISPOT assay and 11 patients responded in both assays, including the patient who only received three doses of 2mg of SCIB1. Broad, high frequency responses were seen against both the two CD8+ T cell epitopes and against the two CD4+ T cell epitopes. Six patients responded to all four epitopes, five patients responded to three epitopes and three patients responded to two epitopes. Statistically significant responses (p>0.0001) were seen after three, four or five immunisations but not after two, indicating that at least three doses are required for a strong immune response to develop.

Due to these encouraging results six patients are continuing on extended, long-term treatment with SCIB1.


Tolerability and Safety

The SCIB1 immunotherapy produced very few side effects, none of which were serious, with no new or unexpected issues found over those reported with the results from Part 1 of the study where no systemic dose-limiting toxicities were observed. The most commonly reported adverse events were injection site reactions and cold- and flu-like symptoms. The electroporation procedure itself was less well-tolerated in some patients and, in certain cases, required pre-treatment sedation. However, only one patient has withdrawn from the study for this reason and seven chose to continue treatment in Part 2 of the study (one has since discontinued).



About Scancell
Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope® technology platforms. Scancell's first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

Scancell's ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity. The Directors believe that the Moditope® platform could play a major role in the development of safe and effective cancer immunotherapies in the future.

This information is provided by RNS, the company news service from the London Stock Exchange

SCANCELL TO POST SUCCESSFUL CANCER VACCINE TRIAL RESULTS

Britain's Sunday Times newspaper gave investors the 'head's up' on Scancell's cancer vaccine trial success today:


Boffins in skin cancer success

A BIOTECH business developing a treatment for melanoma, a deadly form of skin cancer, is set to publish data that shows it appears to work.

The success of the trials on about 20 patients is likely to prompt Scancell, which is listed on AIM, to try to raise funds from a big pharma company to carry out tests with a far larger number of people. It does not have the infrastructure to run big tests on its own.

Such a deal could see the company license its technology to a partner or sell itself outright.

The British company’s treatment tackles cancer cells using the body’s immune system. Several of the world’s biggest drugs developers, including Roche and Merck, are interested in this type of approach to treating cancer.


Read the complete article here:
Boffins in skin cancer success

Interview With Joint CEO, Professor Lindy Durrant

Video Link

SCANCELL LOOKING GOOD WITH MELANOMA IMMUNOTHERAPY

A new article from Investing.com by Alberto Savrieno

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I think the numbers are about anticipated developments.

The intension is to offer the company up for sale within the next couple of years and there is a widespread belief that Scancell will fetch big numbers when this happens.

The directors have indicated during an investor presentation in March 2012 that they expect to receive about $1 billion dollars for their SCIB1 melanoma vaccine alone. SCIB1 will have completed Phase I/II trials when the company goes under the hammer. (Compare Johnson & Johnson's June 17th $1 billion acquisition of Aragon Pharmaceuticals for their lead drug to treat prostate cancer, just completing Phase I/II trials.)

But it is important to bear in mind that SCIB1 (ScanCell ImmunoBody 1) is a showcase vaccine for Scancell's re-programmable DNA vaccine platform, ImmunoBody, which will be included in the sale of the company. ImmunoBody allows whoever buys Scancell to produce new 'quick fire' vaccines in weeks to treat any kind of cancer by making small alterations in the vaccine's DNA code. This technology is fully patented and is unique to Scancell.

Scancell has already pre-prepared a second ImmunoBody vaccine, SCIB2, which has completed successful animal studies and is now ready for human trials. SCIB2 is designed primarily to treat lung cancer but is also able to treat oesophageal, liver, gastric, prostate, ovarian and bladder cancers without re-programming.

Moditope™
In addition to Scancell's re-programmable DNA vaccine the company has also developed a second, equally unique, vaccine technology called Moditope.

Up to now scientists using the cell mediated part of the adaptive immune system to fight cancer and viruses have only been able to draw on the assistance of CD8 Killer T Cells to kill cancer and various viral pathogens. But it has long been suspected that CD4 T Cells which normally function as helper cells to aid CD8 Killer T Cells to multiply and work better are able to switch roles and turn into cancer and virus killing cells in their own right. It is believed, for example, that in those instances where a person contracts HIV but proves naturally resistant to the virus and remains AIDs free, it is because these rare CD4 cancer and virus killing cells are produced naturally in those particular individuals.

On January 20th 2013 a research team led by the La Jolla Institute for Allergy & Immunology announced it had discovered the mechanism that nature sometimes uses to enable CD4 Helper T Cells to assume this more aggressive role of Killer T Cells in mounting an immune attack against viruses and cancer but have as yet no practical method to artificially stimulate usable populations of CD4 Killer T Cells in patients. Although published in January of this year the La Jolla team's work was peer reviewed prior to August last year, so when their scientific paper was written they would have been unaware of the new breakthrough discovery and invention of Professor Lindy Durrant, Joint CEO of Scancell Holdings.

On 15th August 2012 Scancell announced the development of a new platform technology, Moditope, that stimulates the production of Killer CD4 T Cells with powerful anti-tumor activity and that the Directors believed "this new discovery could have a profound effect on the way that cancer vaccines are developed."

What Professor Durrant's team had done at Scancell was to find a way of modifying epitopes of cancer and viral antigens (those parts of the cancer and virus recognized by the immune system and incorporated routinely in vaccines to fight these conditions). These specially modified epitopes (Moditopes) were discovered to artificially generate CD4 Killer T Cells in mice and in the tissue of cancer patients. It is now the intention of Scancell to develop a showcase vaccine to display the superior cancer killing capability of these new vaccine components and at the same time license them out for use by other vaccine manufacturers and government agencies to enable their existing vaccines to function with greater potency.

Future valuation of Scancell on sale
Scancell's Directors have recently suggested that instead of spinning Moditope out as a separate company (which they were originally expected to do) they might include this extremely valuable technology in the sale of Scancell as well. If this goes ahead it would add a vast and incalculable sum of money to the likely offer price for Scancell.

Without Moditope, valuations among investors of Scancell on sale range from $5 to an incredible $13 per share! But if Moditope is to be added into the mix then I would expect these figures would receive a sharp upward correction.

Stimulation of killer CD4 T cells with potent anti-tumour activity

Gift_Horse, Scottrade shows O/S of 223 million shares and market cap of roughly $100 millions. How do you feel about having almost quarter billion O/S at this early stage and a market cap of over $100 million? Do these numbers look reach for an early stage biotech?

-null

Disclaimer: Everything is just my opinion. Please do your own due dilligence.

null,

Surprised at the difficulty you experienced with Scottrade online, especially since those were the instructions they provide themselves for buying foreign Ordinary Shares on the OTC Grey Market:

See paragraph entitled, 'Trading ADRs and ORDs listed in the Grey Market'

Anyway, as you indicated, phoning your nearest Scottrade office should resolve things.

Re: Scancell and funding
Cash calls are a pretty rare occurrence when it comes to Scancell. They run a pretty 'tight ship' and cash burn is less than £2 million a year. The recent funding in July netted them £6.5 million; so that should last them a good 3 years. In the meantime they are expected to put the company up for sale. This could happen before the end of 2015. I say this because the principal directors have several million share options to cash in providing they sell the company by then.

Gift_Horse, thank you for the detailed reply. Appreciate your help. While trying to place limit order online, I am getting below error.

Unable to enter the order because no bid or ask price could be found for the symbol you entered.

It seems I will have to use the other alternate that you mentioned and would require broker assistance to place the trade.

What are your thoughts on future dilution? Do you think they have it covered for now until the results come out or they will have to do something to address financing in near future (before the results), like they did very recently?

-null

Disclaimer: Everything is just my opinion. Please do your own due dilligence.

HOW TO BUY SCANCELL (SCNLF) THROUGH SCOTTRADE


Trading ADRs and ORDs in overseas stocks listed in the Grey Market wih Scottrade

Available ADRs and ORDs can be traded the same way as U.S.-listed stocks on the Scottrade Trading Site.

The primary difference between trading ADRs and ORDs listed on the Grey Market and trading other stocks is that they do not provide an inside bid/offer so only limit orders are allowed. These can be broker assisted or executed online.

Online:
When buying SCNLF you will need a realistic limit price per share to enter in the Limit Price field (see below). This can be obtained by finding the ask price in London and using the Pound / Dollar exchange rate to find the dollar equivalent. You should then add a few cents to allow for subsequent price movements and a working limit price. Your order will then be executed at the best possible price below your specified limit. Today $0.64 would be a reasonable limit price to buy SCNLF.


Placing an online limit order for overseas stocks (such as Scancell) listed in the grey market with Scottrade



1. Click on the Trade tab to begin.

2. Using the Buy/Sell drop-down menu, select Buy.

3. Next, enter the number of shares you want to buy and symbol (SCNLF).

4. From the Order Type drop-down menu, select Limit. As soon as you select Limit, the Limit Price field will automatically display. Enter the upper limit you are prepared to pay 'per share' in the Limit Price field. Then select Good Until Cancelled in the Duration drop down menu.

5. You are now ready to click the Review Order button and place your trade.


By Cell Phone:



Broker Assisted:
Alternatively you can contact your nearest Scottrade office and place your order for Scancell (SCNLF) in person. Again you will need your limit order price ready (e.g., $0.64). Use this link to locate your nearest Scottrade branch office:
Find the Nearest Scottrade Office

Help Please!

Is there a way to purchase this security through Scottrade? I do not see any trades or bid/ask? I understand that this security is listed on London Stock Exchange. Any help in this matter will be greatly appreciated.

-null

Disclaimer: Everything is just my opinion. Please do your own due dilligence.

WHEN WILL SCANCELL BE SOLD?

Originally the directors planned to sell Scancell following completion of Part 2 of their ImmunoBody® vaccine's Phase I/II trial this December. But two extraordinary developments have led to a rethink on timing.

The first was a chance discovery which led to the development of a new revolutionary vaccine technology called Moditope™ and the second was the astonishing tumor shrinking power of their established vaccine technology ImmunoBody®.

Moditope™
Moditope™ has the power to generate special cancer and virus killing immune cells called Killer CD4 T Cells. The type of cancer and virus killing immune cells that Scancell and other vaccine makers have been able to generate up to now are called Killer CD8 T Cells. CD4 T Cells play their part in Scancell's and other companies' vaccines but only as Helper Cells. Until Moditope™ no vaccine maker had a way of switching these Helper CD4 T Cells into Killer CD4 T Cells which are believed to be highly effective and doggedly tireless in their cancer and virus killing role. Scientists believe that some people don't develop AIDs when infected with HIV because their bodies have the very rare ability to switch some CD4 T Cells into virus killing cells. So Scancell's discovery is truly groundbreaking and is expected to be used not only by Scancell but by many other vaccine companies to increase the potency of their vaccines to treat both cancer and viral pathogens such as HIV AIDs.

ImmunoBody's® tumor shrinking power
Part 1 of Scancell's ImmunoBody® vaccine trial began in June 2010 and concluded with a report published in December 2012. Called SCIB1 and designed to treat melanoma it was principally being tested for safety and tolerability by giving late stage melanoma patients different dose concentrations of the vaccine. Tests were also run for immune response and one year survival rates which exceeded current treatment options for melanoma by a considerable margin but the truly astonishing result that halted the company in its tracks was the ability of the vaccine to shrink tumors up to 100% in one patient who had not had her tumors surgically removed beforehand, clearing away completely all metastatic tumors from her lungs. Scancell's fellow manufacturers of dendritic cell vaccines (the only type of FDA approved therapeutic cancer vaccine in the market place) could not achieve anything like this when it came to physically shrinking patients' tumors. Dendreon's Provenge vaccine, for instance, is famous for not shrinking tumors, Northwest Biotherapeutics openly admit that they can't shrink tumors and the only dendritic cell vaccine manufacturer that has shown their vaccine capable of shrinking tumors, Celldex Therapeutics, does so by no more than 21% compared to the 100% tumor shrinkage achieved by Scancell's SCIB1 ImmunoBody® vaccine.

The need for a special tumor trial
This called for a radical rethink for Scancell. It became immediately obvious that the price they could command for the company in a trade sale would be greatly bolstered by further evidence of this tumor shrinking capability that sets Scancell apart from its cancer vaccine competitors. But the company had only budgeted for the final (Part 2) of SCIB1's Phase I/II trial. And Part 2 was to take place in 13 patients who didn't have tumors to shrink. The trial design stipulated that this part of the Phase I/II study was to be in patients who had received surgery to remove any tumors present and given the vaccine to test its ability to prevent recurrence.

So Scancell hastily sought permission from the regulators to extend Part 1 of the trial to include a fresh cohort of patients with tumors still in place. They also asked to trial a higher 8mg dose of the vaccine in these patients, believing that this new higher dose could make even more obvious the tumor shrinking power evidenced earlier. But funds were low and no more than 3 to 6 could be recruited.

Beefing up the master plan
As summer approached Scancell was getting closer to the deadline to complete their patent application for Moditope™ and it became increasingly obvious that funding would be needed to prevent this groundbreaking discovery gathering dust. Doing nothing, as Joint CEO Richard Goodfellow was later to explain to shareholders in emails, was not an option.

So fund managers Calculus Capital, longstanding investors in Scancell, agreed to stump up £4.5 million which together with the proceeds from an Open Offer to shareholders provided £6.5 million. Enough to fund the preclinical development of a showcase Moditope™ vaccine and beef up the numbers on the all important ImmunoBody® tumor trial to 13. A reasonable quantity to show SCIB1 can replicate its tumor shrinking capabilities in other metastatic melanoma patients with tumor load.

This funding in place, Scancell's Board now believes it can meet the two key objectives it feels necessary for the company to achieve full value in the proposed trade sale of the business to a large pharmaceutical company. The first to demonstrate in full the unique capabilities of Scancell's ImmunoBody® vaccine, SCIB1, to not only significantly extend survival but also to eliminate metastatic tumors in late stage melanoma patients. The second to progress the company's new groundbreaking vaccine technology, Moditope™, which the directors believe "could have a profound effect on the way that cancer vaccines are developed."

Conclusion
Given these new objectives and considering the current incentive scheme to reward key directors with options in the event of a sale, I have concluded that the latest period the Board can be expected to seek a buyer would be sometime between Spring and Autumn 2015. But it should be born in mind that an unsolicited approach could come at anytime. In this regard it might be apposite to note that the Nottingham Post reported on Thursday August 1st 2013 that both Scancell's platforms, ImmunoBody® and Moditope™, "have attracted unsolicited interest from large pharmaceutical companies."

General Meeting - Shareholder No.2's Account:

Following on from the my previous post which featured an account of Thursday's General Meeting by the LSE poster ciaskin, here is a second account by another shareholder who also attended, dragon101, consisting of two posts to LSE Scancell Chat. The first was posted Thursday evening and the second on Friday morning.


dragon101 arrives home after attending Scancell's General Meeting and posts this:

Meeting

Hi Everyone, it was great to go to the meeting today and get a feel for the BOD. I have to say, I feel very confident about the entire operation. Now the BOD mentioned there will be an investors day on the 1st October, so I suggest anyone who is genuinely interested in Scancell, take the time to attend.

Main points for me are as follows:

EIS will have very little bearing on the decision to sell. The goal is to create the maximum value for all shareholders.

Moditope is the jewel in the crown and according to Lindy works in " beautiful synergy" with the ImmunoBody platform and can target almost all cancers.

I will go through my notes tomorrow and post a more detailed report.



The following morning dragon101 has prepared his more detailed account and posts this:

Meeting Notes

Hi Everyone,

As promised, I have gone through my extended notes from the meeting and below I have summarised in my own words what was discussed:

After all the formal proceedings had been concluded, Dr. Richard Goodfellow (RG) and Prof. Lindy Durrant (LD) gave brief presentations with comments from the Chairman David Evans (DE).


Summary of RG Comments:

Richard talked about how ‘Cancer Immunotherapy’ has evolved over the years to become a headline act at the words biggest forum (ASCO)

Analysts have woken up to this with one leading Citigroup analyst suggesting the market could be worth up to 35 billion dollars.

The problem with current targeted cancer immunotherapy such as Dundreon’s Provenge) and Yervoy (Ipilimumab) are the huge costs and risk of serious side effects are possible, and the fact that for example with Ipilimumab that it’s difficult to predict which of the 5-10% of people will respond.

FDA have fast track approval for breakthrough treatments, potentially saving pharma years of development costs, and this could be possible for therapies like those being developed at Scancell.

Likely date will be 1st October for more in depth presentation and discussion on Moditope.

Moditope

RG then went on to talk about how the surprising discovery of Moditope led to a change in strategy and a discussion on how best to move forward. Three options were discussed:

1, Do Nothing

2, Spin out in to a new company vehicle

3, Raise funds through a placing

It was felt that option 2 would be too complicated; leaving this “very exciting discovery” on the shelf was not an option, so raising funds through a placement was deemed the best course of action.

RG could not say much more because the Moditope patent has yet to be published. This will be discussed in more detail at the investor’s day, which is likely to be held on the 1st October, where there will be more detailed presentations.

RG is still very excited by this technology and indicated that the additional funding along with phase 2 SC1B1 results and the Moditope development will give him fire power to enter into talks with potential buyers.


Summary of LD Comments:

Lindy then made a brief presentation. The key points were the “beautiful synergy between ImmunoBody and Moditope” and the fact she has identified Moditope epitopes which could work with virtually any Cancer.


Questions:

There were some interesting questions from the floor, in regards to the Frankfurt Video, SCIB2 development and the idea of selling multiple licences in the style of ARM holdings

RG was asked about the video and at this point, they had not made a decision about the future strategy for Moditope. It was always imagined that the first point of any potential sale would be with the release of the phase 2 SC1B1 data.

SCIB2 will not be developed further, this is due to Scancell having to prioritise and focus on bringing Moditope to clinical trial and extending the 8MG SCIB1 trials.

DE then confirmed that they have not been in any discussion with Pharma companies and shareholder value will be enhanced with the further investment in Moditope and probably selling the 2 platforms together would be the way to maximise value.

Phase 3 research is not likely as is not within the expertise of this company, and would require a different type of leadership. The strategy is not set in stone but he indicated he feels that is an incredibly exciting platform in its own right and that Moditope came out of that research as a chance discovery.

EIS will have little effect on the timing of selling. The BOD’s ultimate focus is to maximise value for all shareholders.

DE, finished the meeting by saying;

Ultimately they are still focused on the end game to crystallise value and sell, however this strategy is not set in stone and it may be that the company would consider an ARM Holdings type business model.

Scancell have never been so financially well placed and this has had the effect of giving Lindy and her team the greatest level of certainty that they have an opportunity to realise the potential of their research.

The BOD thanked shareholders for their continued support.

General Meeting - Shareholder No.1's Account:

I have decided to post the accounts written by shareholders who attended Scancell's General Meeting held in London at 10 a.m. on Thursday August 1st 2013. These accounts were first posted to London South East Scancell Chat and give a flavor of what went down at the meeting itself which was a darn sight more interesting than the bald Regulatory News issued by the London Stock Exchange later. For clarity I have supplied annotations where necessary in square brackets.

Shareholder No.1 (username, ciaskin) posted the following account on LSE Scancell Chat at 15:01 on Thursday.

MEETING OUTCOME

I will post this only once and will not get into any protracted debates with anyone. I am also neither a ramper nor a deramper: this is simply an accurate report of this morning's meeting from my handwritten notes.

Meeting was in four parts: formal resolution stuff (c 15 mins); presentation from RG & LD [Dr. Richard Goodfellow & Prof. Lindy Durrant, Joint CEO's of Scancell Holdings] (c 25 mins); Q & A from the floor (25 mins) and then another 20 minutes or so of informal, post-meeting chat.

Resolutions all passed; RG presentation reinforced the potential size of the immunotherapy market - $35 billion per annum within 10 years, making it the biggest drug class in history. Immunobody recap - SCIB1 Phase 2 still on course for results in Q4 2014. [This should read "results in Q4 2013" see below] Deadline for final tweaks to Moditope patent submissions is August 7th. They are planning Investor day (tentative date October 1st) for IIs, PIs et al to update on both platforms - but especially Moditope. The £6.5m raised (£6,2M after expenses) will be used for preclinical work on Moditope and to put Immunobody platform "to a good place". As importantly, it gives them "greater firepower to enter into negotiations". More cash in bank means they are less likely "to get screwed".

LD then turned to the science: 4 out of the 6 patients on the 2mg and 4mg doses of SCIB1have shown immune repose and remain alive.In part 2, 13 patients in total are recruited for the 4mg dose and results are on track for Q4 2013. She also mentioned that she expected the immune response of SCIB1 in combination with existing products like Yervoy, to be very strong.

Questions
When asked about potential sale of the asset(s), DE [David Evans, Scancell's Chairman] said that they saw a situation "where 1+1=3", from which I inferred that Immunobody and Moditope would ultimately be sold together - the sum being greater than the parts - at a time when SCIB1 is proven, (meaning that SCIB 2, and potentially 3,4 and 5 are significantly de-risked) and Moditope has full patent protection and pre-clinical work largely done. A much more attractive proposition to pharma, and with more cash in bank, a much better negotiating position.

Question also about EIS shares [shares bought through the Firm Placing by Calculus Capital on behalf of investors in an EIS scheme which carries tax benefits if held for 3 years] hampering the potential sale date. Dismissed by DE as he believes "the tax tail should never wag the dog" and if the right deal comes along which crystalises shareholder value then they would go for it. (So let's bury that one, once and for all).

Question/observation also (from Inanaco, I think [another LSE poster attending the meeting]) about whether there would be licensing opportunities for Moditope (a la ARM Holdings). Awkward silence from BOD - possible but no commitment. So nothing ruled out, and nothing ruled in.

My first meeting of this kind and very glad I went; confidence in BOD restored, money in bank, science progressing well and on time, clear plan & exit strategy. There will probably be SP volatility over the next week or so, but good news flow, investor meeting, RNS etc should keep this rising, methinks. Remains a very...strong hold for me, with buying on the dips .

DYOR etc...

C

RE: $1.94 Target Price

It is important to point out that the BUY rating and $1.94 target price for Scancell's shares was issued by Cenkos Securities in response to the decision to seek the £6.5 million of funding via the issuing of 28,888,888 new shares. So the $1.94 target price is based on the 223,358,373 ordinary shares which will now be in issue as a result of this funding.

Very little really. We are talking about 28,888,888 new ordinary shares giving us a total issued share capital now of 223,358,373 ordinary shares. The dilution is modest, just 13%. Also extra funding of £6.5 million is now in place for several years ahead.

The company uses less than £2 million a year to run its operations. This puts Scancell in a far stronger negotiating position with a potential buyer of the company. It now has the resources to play hardball.

The shares traded OTC here are exactly the same shares traded in London except they are priced in dollar equivalents.

What does all these new shares added mean for us? SCNLF $$$$

REGULATORY NEWS: RESULT OF GENERAL MEETING

RNS Number : 7297K
Scancell Holdings Plc
01 August 2013

?
Scancell Holdings plc
("Scancell" or the "Company")
Result of General Meeting

The Board of Scancell announces that all resolutions put to shareholders at the Company's General Meeting held earlier today were duly passed.

Application has been made for a total of 28,888,888 new ordinary shares to be admitted to trading on AIM. Dealing is expected to commence in respect of 22,222,222 new ordinary shares at 08:00 on 2 August 2013 and in respect of 6,666,666 new ordinary shares at 08:00 on 5 August 2013.

In conformity with rule 5.6.1 of Disclosure and Transparency Rules, the Board of the Company notifies the market of the following:

The total number of ordinary shares of 0.1p each in Scancell in issue following the admission of the 28,888,888 new ordinary shares will be 223,358,373 with each share carrying the right to one vote. There are no shares held in Treasury. The total number of voting rights in the Company will following admission of the Offer Shares therefore be 223,358,373. The above figure may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, Scancell under the FSA's Disclosure and Transparency Rules.

David Evans, Non-Executive Chairman of Scancell, said: "With funding now secured, we can focus on advancing both of Scancell's cancer immunotherapy platforms to key value inflection points that we believe will further support their future role in the rapidly growing new approach to cancer treatment. We look forward to providing updates on our progress in due course."

For more information, please visit www.scancell.co.uk or contact:



For Further Information:

Scancell Holdings Plc:
David Evans, Non Executive Chairman +44 (0) 7740084452
Dr Richard Goodfellow, Joint CEO + 44 (0) 74 2323 0 497


FTI Consulting:
Simon Conway/Mo Noonan + 44 (0) 20 7831 3113


Cenkos Securities plc:
Camilla Hume/Stephen Keys +44 (0) 20 7397 8900



Notes for editors:

About Scancell

Scancell is developing novel immunotherapies for the treatment of cancer based on its ImmunoBody® and Moditope™ technology platforms. Scancell's first ImmunoBody®, SCIB1 is being developed for the treatment of melanoma and is in Phase 1/2 clinical trials. Preliminary evidence from Part 1 of the study showing that SCIB1 produced an immune response which might be associated with clinical benefit in patients with malignant melanoma was released in December 2012.

Scancell's ImmunoBody® vaccines target dendritic cells and stimulate both parts of the cellular immune system; the helper cell system where inflammation is stimulated at the tumour site; and the cytotoxic T-lymphocyte or CTL response where immune system cells are primed to recognise and kill specific cells.

Scancell has also identified and patented a series of modified epitopes that stimulate the production of killer CD4 that destroy tumours without toxicity. The Directors believe that the Moditope™ platform could play a major role in the development of safe and effective cancer immunotherapies in the future.


This information is provided by RNS
The company news service from the London Stock Exchange

END

SCANCELL'S PLATFORMS ATTRACT UNSOLICITED INTEREST

Scancell raises £6.3m for cancer vaccine trial

CENKOS SECURITIES PROVIDES $1.94 TARGET PRICE

Analyst Navid Malik, Head of Life Sciences Research at Cenkos Securities, maintains his BUY rating for Scancell's shares with a target price based on expected news flow of $1.94* per share.

*127.89 pence = £1.28 = $1.94 [pounds and dollar amounts are rounded and based on today's exchange rate].

NAVID MALIK:
Dr. Navid Malik is the Head of Life Sciences Research for Cenkos Securities Plc. in the UK, and has been one of the most influential analysts in the UK and Europe over the last decade, covering the life sciences industry worldwide. In 2011, Dr. Malik was awarded two Starmine Awards (awarded each year by Thomson Reuters and the Financial Times): Number One Stock Picker in the European Pharmaceutical Sector, and Number Two Stock Picker in the UK and Ireland Healthcare Sector. Dr. Malik has built life science teams and franchises at multiple large financial institutions in London, which completed IPOs and secondary stock offerings for small biotech and life sciences companies totaling over $700 million in recent years, and which also initiated research coverage on dozens of small life sciences companies in addition to covering large pharmaceutical, biologics and healthcare companies. Dr. Malik holds a PhD in Drug Delivery within Pharmaceutical Sciences, as well as degrees in Biomedical Sciences Research (M.Sc.) and Biochemistry and Physiology (B.Sc., joint honors). Dr. Malik also holds an MBA in finance.

WEBCAST - SCANCELL HOLDINGS - COMPANY UPDATE

Here is an up to date picture of Scancell via a webcast interview with the company's Joint CEO Dr. Richard Goodfellow, broadcast by BRR Media on Monday, 22nd July 2013:

Webcast interview with Scancell's Joint CEO Dr. Richard Goodfellow

Judging from your buying, it looks just as easy to get out as to get in. I can't see the difference so far from buying in London. You get the same ask so presumably you will get the same bid ....... only in dollars and cents rather than in pounds and pence.

The only inconvenience is that you don't get quoted a bid and ask directly on the Grey Market. But you can work them out by using the London bid and ask and the exchange rate.

SCNLF sounding better all the time. Question, selling. I have heard it can be hard to exit your position in the grey market, what say you? SCNLF $$$$$ I have two other tickers I am in for a 2 month play, hopefully shorter. When I exit my holdings of SCNLF shall increase exponentially...$$$$$

GG Gums,

Actually the target price (issued by the award winning analyst, Navid Malik, of Cenkos Securities) is 127.89 pence to be precise (£1.27). Although Yahoo has it as a 1 year target (as they do with all submitted targets) the target itself is a momentum target and is an indication of where the stock might climb given expected news flow.

In Autumn (most likely September) Scancell is to give details of its new vaccine technology called Moditope™. Vaccines against cancer and viruses stimulate Killer T Cells to attack and destroy these diseases. Scancell's Moditope™ for the first time induces a rare type of Killer T Cell known as a CD4 Killer T Cell. They are more long lasting in their killing effect than the existing type of cancer and virus killing cells available to scientists at the moment which are known as CD8 Killer T Cells. Normally CD4 T Cells don't kill directly but they do help the CD8 Killers to increase in number. Scancell has found a way of causing these CD4 Helper Cells (as they are commonly known) to switch their roles from simple helpers to full blown killers. This is the first time that anyone has successfully done this.

Scancell now plans to showcase this technology in a vaccine of its own and to license this new discovery to other companies to make their vaccines work more powerfully. For instance, patients who get infected with HIV and don't develop AIDs are believed to be protected by their body's rare ability to switch its own CD4 Helper Cells into these tireless Killers which then go on to eradicate or prevent the HIV infection. So Scancell expects its technology to be used not only to make cancer vaccines more potent but also by vaccine manufacturers to fight HIV and other infectious diseases.

The discovery of Moditope™ was first announced last August (2012) but Scancell has been given 1 year to finalize its patent before filing. That period ends next month and the details of the discovery are expected to be published for the first time in September. This is likely to be accompanied by a great deal of publicity on both sides of the pond. The share price could easily hit a dollar or more at that time.

Moditope™

Well that is fine with me a few extra months to highly increase the buy offer is alright in my book. I knew coming in that it was a longer play. I see the parent company over the pond has a $127.00 price target, nice. Could turn out to be a nice x10. SCNLF $$$$

GG Gums,

Timescales to the intended 'offer for sale' of the company have lengthened recently.

Following Scancell's funding round which included a £4.5 million injection from Calculus Capital and a successful £2 million Open Offer to shareholders there will be an extension of their lead vaccine's clinical trial. They will also progress their new vaccine platform Moditope with these extra funds.

The directors intend to sell the company on conclusion of the Phase I/II trial of their skin cancer vaccine SCIB1. The final part of this trial (Part 2) is due to conclude this December which was the expected period when the company would be offered for sale. But because of remarkable results in Part 1 which included 100% shrinking of tumors the directors have decided they would get a much higher price for the company if they could set up an additional mini-trial in patients with extensive secondary tumors in order to showcase this capability to shrink and eliminate tumors. At the moment no manufacturer of authorized therapeutic cancer vaccines can do this.

So far, only one type of therapeutic cancer vaccine has been approved by the FDA, the dendritic cell vaccine; this is the same type of cancer vaccine that Scancell produces. But until Scancell's SCIB1, dendritic cell vaccines have been unable to provide examples of eliminating tumors completely. Dendreon's Provenge for prostate cancer, for example, has never been able to shrink tumors. Northwest Biotherapeutics has openly admitted it can't shrink tumors and the only dendritic cell vaccine manufacturer that has shrunk tumors, Celldex, has only done so so by 21% compared with Scancell's 100%. This was felt by Scancell to be such an important feature of their vaccine that they will now extend this extra tumor trial by a further 10 patients. This could add a year to eighteen months to their schedule to offer up the company for sale.

But, generally that's not how companies get sold anyway. Big Pharma is on a buying spree at the moment, as its patents are running low and they are looking to plug the gap. Citigroup estimate that the market for Immunotherapy treatments could be worth an astonishing $35 billion a year over the next 10 years. So Scancell remains squarely in the bull's eye as an acquisition target for the industry.

Thanks for the insight, I had a $1 dollar bid on my first trade just to find a price. My guess is the pound gains on the dollar later in the year around the time for the proposed "sale" of the English Company, would that give us a better or worse? The CEO recently bought a lot of shares on the open market. Follow the leader.... SCNLF $$$$

GG Gums, Best way to do it. I was going to suggest you might take a few to get a handle on the price. Given the exchange rate, not much different than buying in London. You should be able to trade your shares just as well here as there. That's a confidence builder.

I have you down as paying $0.52 per share. That's £0.34 given the exchange rate. Someone paid the same in London for 4,443 shares.

Obviously exchange rates come into it. That adds an interesting dimension. Nevertheless the exchange rate has remained pretty steady, between $0.60 - $0.67 to the £ since 2011 (check out 5 year chart). Still, its a margin.

Took a very small starter position today, yes that's my toe in the water for 450 shares. Is this a better play then the mother company SCLP.L ?? I think with the exchange rate now @.65 pounds for dollar a currency uptick by December might be in play, projected PPS $127 pounds. Could be a better option, this "Grey" is a hard play cannot see numbers that matter. Input needed. SCNLF $$$$$

Life saver$$$ Thank you. SCNLF $$$$

You are looking at around $0.60 ask.

SCNLF $$ Thanks for the reply, I have E-trade and cannot even get a trader there to give me a quote on what to bid since it is on the "Grey" market. Can anyone here tell me the current ask? Thanks in advance. $$$

You can buy in $$$ now. Etrade or Scottrade should be able to get them for you.

ETRADE'S SCANCELL PAGE

SCOTTRADE'S SCANCELL PAGE

When can you buy in?? SCNLF $$$$

SCANCELL'S FUNDING & OPEN OFFER TO SHAREHOLDERS

Scancell (SCLP.L) the cancer vaccine firm has just sought a round of funding via a Firm Placing to Calculus Capital and a 1 for 22 Open Offer to shareholders. This entails a modest dilution of some 13% which shareholders can offset somewhat by accepting their allocated shares priced at a heftily discounted 22.5p. The company hopes to raise £6.5 million to fund additional recruiting of a further 10 patients to part of its SCIB1 skin cancer vaccine trial and the pre-clinical and early clinical development of Scancell's newly discovered vaccine technology, Moditope. Here is an excellent post written by a Scancell shareholder on Interactive Investor's Scancell discussion board:

Yes, I have just completed my online application, I will be taking up my full allocation as well.

I support the decision to get some extra funding for 10 more patients on the 8mg cohort and the development of Moditope. 13 or so patients will be a reasonable number to see the effects of the SCIB1 vaccine on this special subset of patients. I also agree with the statement that Richard Goodfellow has made in emails that allowing Moditope to remain on the shelf without progression was not an option.

The decision itself is as a result of talks with investors over the funding of Moditope going forward. They came to the right decision. The patent exemplification period for Moditope ends in August by which time they have to include all possible applications and details of their discovery. So after that it is full steam ahead for Moditope.

What I found particularly interesting though was the update on the progress of SCIB1's dose escalation study i.e., part 1 of the Phase I/II trial. Of those 6 patients who have received working doses of the vaccine at either full or half strength (2mg or 4mg doses or a combination of the two) 4 patients or 66.6% are surviving longer than a year and one for 2 years. Now this is only a small data set from a dose escalation study principally designed to test for toxicity but it compares very favourably indeed with the best that the melanoma treatment market is currently offering.

For example, Bristol Myers Squibb's Yervoy (ipilimumab) Phase II trial produced a one year survival rate of 47% to 51% for people with stage III or IV melanoma. The gp100 peptide vaccine plus Yervoy 46% and Yervoy plus the chemotherapy drug dacarbazine 43.7%! Also Yervoy of course is extremely toxic where Scancell's SCIB1 isn't. Yervoy was recently approved by NICE for the treatment of metastatic melanoma by Britain's National Health Service.

Part 2 of the SCIB1 Phase I/II trial, designed to eradicate micro-metastases and prevent recurrence of disease in 13 patients who have had their tumours surgically removed beforehand, is on track to be completed by the end of the year.

Back to the additional 8mg (double dose) trial tagged onto part 1, which resulted from the discovery made in the early dose escalation studies that SCIB1 successfully eliminated target tumours in one patient that had not had them surgically removed beforehand. The extent of this eradication now becomes clear. All target tumours were reduced substantially up to 100% and all lung secondaries were eradicated. A remaining abdominal tumour it now transpires was unrelated to the patient's melanoma (that is it did not exhibit melanoma antigens when surgically removed) so would not have been treatable by the SCIB1 vaccine anyway. This is truly exciting. Hence Scancell seeking permission for the 8mg cohort last December on patients with their tumours still present. They have 3 now and they will recruit an extra 10. The reason why this is now so important for Scancell is that none of their cancer vaccine competitors can shrink or eliminate tumours in this way. The market leader Dendreon has never shown it can shrink tumours, Northwest Biotherapeutics readily admits it can't shrink tumours and the only dendritic cell vaccine manufacturer whose vaccine has had an impact on tumours, Celldex, has only succeeded in shrinking them 21%. This shows the superior strength of Scancell's SCIB1 vaccine over its competitors.

The board are still committed to selling the company and with this extra funding they will have sufficient resources to display their technology to full advantage and command the best price from the industry when its sold.

Shri9

RAT TAT TAT TAT!

Although Scancell plans to sell to the highest bidder in six months time will bidders wait that long?

When my cupboard's bare I go out to the grocery store to stock up, no messing!

Big Pharma's out of patented stock and they ain't messing either!

Two Scancell sized companies have been snaffled up in the space of six days! On June 11th AstraZeneca nabbed Pearl, for its obstructive lung disease inhaler, fresh out of Phase II. Then on June 17th Johnson & Johnson acquired Aragon Pharmaceuticals for its lead drug to treat prostate cancer still in Phase I/II.

Pearl got a $1.15 billion deal for a single drug to treat just one type of lung disease and Aragon got its billion dollar deal for its androgen receptor inhibitor that's no further along the line than Scancell's SCIB1 vaccine is now!

Clearly the big boys don't wait for an invite to come knocking. And when time is such serious money for big pharma, six long months of lost future sales may be a spur to immediate action.

All's peaceful, as tactics are discussed at Scancell manor.
Then an ear shattering, "RAT TAT TAT TAT!"

Yes, that Scancell sized company on next week's shopping list might very well be Scancell itself. And Scancell has a darn sight more product to fill up big pharma's shopping cart than either Pearl or Aragon could offer!

TWO KEY NOTES

There are two key notes playing in the background here. Increasing buying momentum and a M&A climate where a bid could come for Scancell at any moment.

The big pharmas are on a buying spree as their patents expire and their IP pantries get ever emptier. Scancell is a prime target, ticking those golden boxes of immunotherapy and cancer vaccines, where the industry's future income streams will flow the strongest.

In the almost daily announcement of new deals the big boys aren't even waiting for Phase 2 to finish. Its billion dollar deal after billion dollar deal.

The savvy punter will be smelling the confetti of banknotes on the breeze and buying now before the check made out to Scancell gets signed, sealed and delivered.

SELLING THE KEYS TO THE KINGDOM

Scancell has a very simple strategy. Produce a better cancer vaccine than the global leader and sell Scancell on to the highest bidder by the end of the year.

So far only one company has had a therapeutic cancer vaccine approved for commercial use by the FDA. The Dendreon Corporation. Dendreon is therefore the one and only global leader in therapeutic cancer vaccines. But each treatment uses the blood of the patient to prepare it, so because of rejection, can only be given to one person at a time. This is inordinately expensive. So Dendreon's business model has proved to be fatally flawed with each course of treatment costing more than $90,000!

Scancell has found a way round this. It has patented a technology capable of providing the same treatment without having to extract the patient's blood first. Scancell's DNA vaccine can be given to any number of patients from the same batch so is therefore more cost effective, leaving plenty of room for profit.

In other words Scancell has found a short cut to becoming 'King of the Hill.' Whoever buys Scancell and brings its vaccines to market will become straight away the global leader of the cancer vaccine market. That's what's on offer. The keys to the kingdom. And in the expected bidding war to come, that's what will be fought over.

The Intellectual Property of Scancell's skin cancer vaccine, SCIB1, alone has been valued at a billion dollars! But Scancell's DNA vaccine technology allows its vaccines to be reprogrammed to treat different cancers. In fact, any kind of cancer. Indeed its already started the ball rolling for whoever buys Scancell by pre-preparing a second vaccine to treat lung cancer.

Estimates range from $5 to an incredible $18 a share for what the industry will shell out for Scancell's existing vaccines in combination with its reprogrammable vaccine platform. Certainly the coming sale will prove difficult to resist. If one of the big pharmaceutical companies doesn't buy Scancell they hand over to the competition the top global position in cancer vaccines for a generation. A wise person will know that no company can stand by and let that happen! A sizable and convincing bid will prevent such a disaster. So they will fight like dogs to get Scancell. And as they do, its shares will rise and rise. In the end they could well end up climbing to the top estimate of $18 a share!


Scancell's website:

VIDEO INTERVIEW WITH DR. RICHARD GOODFELLOW, JOINT CEO OF SCANCELL HOLDINGS PLC

IS SCANCELL'S SCIB2 VACCINE IN AUCTION?

I have a feeling we're getting closer to a licensing deal for Scancell's lung cancer vaccine SCIB2. Merck Serono is definitely in the frame with its secret tranche of Scancell shares marking its territory. But it may not be alone.

It wouldn't surprise me if Merck Serono has a rival for SCIB2. A deal like that won't come cheap. And there are bigger boys with bigger wallets out there. Merck needs a lung cancer vaccine after its own failed its Phase 3 in December. But is Merck's wallet fat enough to seal the deal?

Increasingly therapies addressing unmet need, such as Scancell's re-programmable SCIB2, are fetching top dollar. Its outstanding preclinical performance and innovative DNA delivery certainly ticks the boxes for breakthrough status with the FDA.

Scancell appears to be offering SCIB2 as a taster ahead of the sale of the company at the end of the year. Its more than a morsel though. Not only is SCIB2 geared up to treat lung cancer but also six further cancers to boot and that's without re-programming!

Scancell has been fending off suitors for years waiting for the big money it can command at the end of Phase 2 trials of its melanoma vaccine, due later this year. So Merck is unlikely to be the only bidder for the SCIB2 licence. There's an edgy quiet about proceedings at the moment with some tense buying pressure building up in Scancell's shares. Is SCIB2 in auction? Expect the unexpected!



Could Scancell's SCIB2 be in auction?

IS SCANCELL ABOUT TO LICENCE ITS LUNG CANCER VACCINE TO MERCK SERONO?

Background to a potential SCIB2 licensing deal
Most relevant to speculation that Merck Serono may conclude a licensing deal for Scancell's lung cancer vaccine SCIB2 is the fact that it already has an option to negotiate an exclusive license under Scancell's ImmunoBody® platform technology for up to five Merck Serono targets. Although this does not formally include SCIB2, we are told by Scancell that this vaccine is now ready for further development and that the company expects "that this work will be undertaken by a licensing partner."

So what other reasons put Merck Serono in the frame as a potential licensing partner for Scancell's SCIB2 lung cancer vaccine?


Merck Serono may seek to replace what's missing
In December Merck Serono's own lung cancer vaccine failed in Phase 3. L-BLP25, licensed from Oncothyreon, like Scancell's SCIB2 was targeted at non-small cell lung cancer. So Merck is missing a vaccine for which SCIB2 seems the ideal replacement.


Merck Serono's 'secret' holding
It may be news to some but as of December 31st 2011, Merck Serono has 1,808,566 shares in Scancell Holdings. So what might this mean? Well Merck held 4.11% of F-Star and then signed a research, license and commercialization agreement with the Austrian firm. It owned 4.9% of Ambrx and last year struck a development and commercialization deal with the company for its biotherapeutic drug conjugates. Now in case the more numerate reader notes that Merck's stake in Scancell represents just 0.93% it might be apposite to point out that Merck held merely 0.75% of Oncothyreon before and after it struck a licensing deal for its ill fated lung cancer vaccine, L-BLP25!

ill buy 50,000,000 shares...

SHARES COULD SKYROCKET!

From an article by Suresh Gupta entitled "Comprehensive Overview Of Active Electroporation Cancer Trials," published on Seeking Alpha:

"Finally, Scancell, a company on the London exchange, is conducting a Phase I/II study on melanoma which looks especially promising. Plasmid DNA called SCIB1 is being electroporated intramuscularly to stimulate T-cells to attack. This phase II trial includes 30 patients who took different doses of the immunotherapy drug. According to a December Scancell press release:

One patient in the 4mg dose group had a long history of metastatic disease and multiple tumour lesions present at the start of treatment (including several in her lungs), all of which decreased in size or disappeared completely following six months of treatment with SCIB1 except for one abdominal tumour nodule which increased in size and which will be resected. This "differential response" pattern is typical of immunotherapeutic agents and is the first signal that SCIB1 may be having an impact on the course of the disease as well as inducing an immune response.

All patients in this trial had either stage III or stage IV melanoma. Of the four patients in the 2-4mg dose, one remains disease free and three of the four are still alive a year after treatment, despite having late stage cancer. The company was given permission to keep treating these patients for 5 years out, which means that although this trial will officially end in 2017, current results will be available at the end of this year.

Scancell has some very impressive results so far and is seeking a buyer when phase II is complete by the end of this year. Given its impressive results for SCIB1, it may be picked up by a big player. If that happens, shares could skyrocket."

Source:
Comprehensive Overview Of Active Electroporation Cancer Trials