TIDMFARN
RNS Number : 5006C
Faron Pharmaceuticals Oy
18 April 2017
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Faron and the University of Birmingham to collaborate on
Clevegen(R) clinical program in liver cancer
TURKU - FINLAND, 18 April 2017. Faron Pharmaceuticals Ltd
("Faron") (LON: FARN), the clinical stage biopharmaceutical
company, is pleased to announce that it has signed an agreement
with the University of Birmingham Medical School, UK, to initiate a
liver cancer program testing Clevegen, the Company's immuno switch
antibody, in clinical trials. This collaboration will focus on
trial and protocol design for a Phase I/II trial, TIETALC, (Tumour
Immunity Enabling Technology Against Liver Cancer) in liver cancer
patients at Birmingham Health Partners' NIHR Clinical Research
Facility and the Centre for Liver Research.
As part of the preparations, approval will be sought from the UK
regulatory authorities (MHRA) for an adaptive protocol, which would
allow flexible administration of Clevegen based on results obtained
in previous dosings. Faron and the University of Birmingham
anticipate filing the clinical trial application (CTA) with the
MHRA in late 2017 or early 2018. In the event of successful
collaboration and CTA approval, it is expected that Faron and the
University of Birmingham will conduct the TIETALC trial
together.
The main focus of TIETALC is to study the safety,
pharmacokinetics/pharmacodynamics and initial efficacy of Clevegen
in liver cancer patients, focusing on those with hepatocellular
carcinoma (HCC). The study will also examine the efficacy of
Clevegen in reducing the number of Clever-1 positive, immune
suppressive myeloid cells, circulating in the blood and entering
tumour tissue of cancer patients where they can suppress
anti-cancer immunity.
TIETALC may also assist Faron with its aim to develop a liquid
biopsy based on recognition of Clever-1 positive circulating
myeloid cells. This detection could potentially become a surrogate
marker of improved immune capacity in response to Clevegen and
assist in the selection of those target cancer patients who are
likely to benefit most from Clevegn treatment.
Dr Markku Jalkanen, CEO of Faron, said: "We are excited to start
this collaboration with this world-renowned liver cancer unit in
Birmingham. Their substantial clinical expertise and numerous
research programmes in liver cancer treatment will provide us with
a unique opportunity to assess the effect Clevegen has on immune
function in these patients. We are optimistic that Clevegen will
stimulate strong immune responses against the cancer, restricting
tumour growth and metastasis, and thereby improving the long term
survival of these patients, whose prognosis with current therapies
is very poor."
Prof. David Adams, Director of the NIHR Biomedical Research
Centre and Head of the College of Medical and Dental Sciences at
University of Birmingham, said: "We are very familiar with the
Clever-1 target molecule. Previously, we have demonstrated that it
controls the accumulation of immunosuppressive regulatory
lymphocytes in the liver(1) and we have also shown in previous
studies that liver cancer can be treated by stimulating anti-tumour
immunity(2) . We are excited to move towards commencement of trials
using Clevegen which we believe has the ability to boost immune
responses against liver cancer through a novel mechanism. The
current prognosis for liver cancer patients is very poor and so
potential treatments, like Clevegen, offer new possibilities in
fighting this aggressive and poorly responsive cancer."
About Liver Cancer
Hepatocelluar cellular carcinoma (HCC) is the most common liver
cancer type and the leading cause of cancer-related morbidity and
mortality worldwide. Less than 20% of HCC patients are alive five
years post diagnosis and there is a clear unmet need for effective
targetted therapies. HCC is usually a complication of liver
cirrhosis which may be caused by viruses, toxins (including
alcohol) or autoimmune liver diseases. Additionally, the liver is a
frequent site of metastasis from other cancers, particularly
colorectal cancer. The immune positive phenotype of HCC and reports
of responses to immunotherapy suggest that is an excellent target
tumour for immuno-oncology treatments by the removal of
immunosuppressive white blood cells including macrophages.
About Clevegen(R)
Faron's preclinical drug development project Clevegen revolves
around Clever-1, a cell surface receptor expressed mainly by
endothelial cells and monocytes/macrophages. Clever-1 is involved
in cancer growth and spread. The active pharmaceutical ingredient
of Clevegen is a humanised anti-Clever-1 antibody.
Clevegen, by binding Clever-1 prevents Tumor Associated
Macrophage (TAM) infiltration into a tumour and blocks
TAM-to-Tumour cell interaction triggering TAM transformation into
tumour supportive cell types. It therefore reduces suppression of
the human immune system and converts the whole immune environment
around a tumour to immune stimulating allowing a patient's own
immune system to combat cancer, known as "immunotherapy". Clevegen
has a local tumour effect which also allows the cell-mediated
immune response to attack infections in normal tissues and removal
of immune suppression locally also limits risk of autoimmune
reaction, a potentially severe side effect observed with some
immune checkpoint inhibitors. The Directors of Faron believe that
Clevegen is well differentiated from competing products as it
specifically targets M2 TAMs which facilitate tumour growth, while
leaving intact the M1 TAMs which support immune activation against
tumours. Clever-1 blocking results especially in activation of Th1
mediated immunity.
About Tumor Immunity Enabling Technology (TIET)
The TIET technology is built around the humanised anti-Clever-1
antibody FP-1305, which binds to a specific Clever-1 proprietary
epitope. Clevegen(R) binding to this epitope activates conversion
of type 2 tumour associated macrophages to type 1 macrophages,
resulting in the transformation of the tumour environment from
immune suppression to immune activation. As the TIET technology is
based on a humanised antibody, the Faron Directors believe it can
be combined with a number of other immune therapies without a
significant risk of increased adverse events. The TIET technology
could provide a significant boost for the efficacy of other immune
checkpoint molecules, as its target is unique and represents a
completely separate control of immunity.
The information contained within this announcement is deemed to
constitute inside information as stipulated under the Market Abuse
Regulation (EU) No. 596/2014. Upon the publication of this
announcement, this inside information is now considered to be in
the public domain.
For more information, please contact:
Faron Pharmaceuticals Ltd
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Consilium Strategic Communications
Mary-Jane Elliott, Chris Welsh, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
E-Mail: chris.brinzey@westwicke.com
Cairn Financial Advisers LLP, Nominated Adviser
Emma Earl, Tony Rawlinson, Rebecca Anderson
Phone: +44 207 213 0880
Panmure Gordon (UK) Limited, Joint Broker
Freddy Crossley, Duncan Monteith (Corporate Finance)
Tom Salvesen (Corporate Broking)
Phone: +44 207 886 2500
Whitman Howard Limited, Nominated Broker (UK)
Ranald McGregor-Smith, Francis North
Phone: +44 207 659 1234
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN) is a clinical stage biopharmaceutical company
developing novel treatments for medical conditions with significant
unmet needs. The Company currently has a pipeline focusing on acute
organ traumas, vascular damage and cancer immunotherapy. The
Company's lead candidate Traumakine, to prevent vascular leakage
and organ failures, is currently the only treatment for Acute
Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical
trials. There is currently no approved pharmaceutical treatment for
ARDS. An additional European Phase II Traumakine trial is underway
for the Rupture of Abdominal Aorta Aneurysm ("RAAA"). Faron's
second candidate Clevegen(R) is a ground breaking pre-clinical
anti-Clever-1 antibody. Clevegen has the ability to switch immune
suppression to immune activation in various conditions, with
potential across oncology, infectious disease and vaccine
development. This novel macrophage-directed immuno-oncology switch
called Tumour Immunity Enabling Technology ("TIET") may be used
alone or in combination with other immune checkpoint molecules for
the treatment of cancer patients. Faron is based in Turku, Finland.
Further information is available at
www.faronpharmaceuticals.com
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed
to be, forward looking statements. Forward looking statements are
identi ed by their use of terms and phrases such as "believe",
"could", "should", "expect", "envisage", "estimate", "intend",
"may", "plan", "potentially", "will" or the negative of those,
variations or comparable expressions, including references to
assumptions. These forward looking statements are not based on
historical facts but rather on the Directors' current expectations
and assumptions regarding the Company's future growth, results of
operations, performance, future capital and other expenditures
(including the amount, nature and sources of funding thereof),
competitive advantages, business prospects and opportunities. Such
forward looking statements re ect the Directors' current beliefs
and assumptions and are based on information currently available to
the Directors.
A number of factors could cause actual results to differ
materially from the results discussed in the forward looking
statements including risks associated with vulnerability to general
economic and business conditions, competition, environmental and
other regulatory changes, actions by governmental authorities, the
availability of capital markets, reliance on key personnel,
uninsured and underinsured losses and other factors, many of which
are beyond the control of the Company. Although any forward looking
statements contained in this announcement are based upon what the
Directors believe to be reasonable assumptions, the Company cannot
assure investors that actual results will be consistent with such
forward looking statements. Accordingly, readers are cautioned not
to place undue reliance on forward looking statements. Subject to
any continuing obligations under applicable law or any relevant AIM
Rule requirements, in providing this information the Company does
not undertake any obligation to publicly update or revise any of
the forward looking statements or to advise of any change in
events, conditions or circumstances on which any such statement is
based.
(1) Shetty et al.( 2011) J. Immunol. 186: 4147-55
(2) Palmer et al. (2009) Hepatology 49: 124-32
This information is provided by RNS
The company news service from the London Stock Exchange
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