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RNS Number : 8347N
4d Pharma PLC
03 February 2021
4D pharma presents update on oncology program
Enrollment progressing well for both expanded Part B of MRx0518
and Keytruda(R) combination study, and pancreatic cancer study
Further analysis of biomarker data in ongoing MRx0518
neoadjuvant monotherapy study
Leeds, UK - February 3, 2021 - 4D pharma plc (AIM: DDDD), a
pharmaceutical company leading the development of Live
Biotherapeutic products (LBPs) - a novel class of drug derived from
the microbiome, today announces progress on activities in its
development program for lead immuno-oncology single strain Live
Biotherapeutic candidate MRx0518.
"4D pharma has continued to make excellent progress with the
MRx0518 development program on multiple fronts. We have generated
additional safety and efficacy data, building on the positive data
from both the monotherapy and KEYTRUDA combination studies last
year. This clinical and development progress has been achieved in
spite of the headwinds of COVID-19," said Dr. Alex Stevenson, Chief
Scientific Officer, 4D pharma. "As 4D pharma extends its leading
position in this exciting and rapidly maturing field, we see the
next 12 months as being instrumental for the space. We look forward
to generating more clinical data from our ongoing studies of
MRx0518 in multiple different tumor types and treatment settings.
This will support 4D pharma's continued productive engagement with
regulatory authorities to develop the clinical strategy to bring
this novel therapeutic to patients suffering from a range of
cancers."
MRx0518 in Combination with KEYTRUDA
MRx0518 is in an ongoing Phase I/II clinical trial in
combination with immune checkpoint inhibitor (ICI) Keytruda(R)
(pembrolizumab), MSD's anti-PD-1 therapy, in patients with advanced
malignancies who have previously progressed on ICI therapy. This
study is comprised of two parts - Part A, an initial safety phase
assessing dose-limiting toxicities of the combination, and the Part
B cohort expansion phase to assess clinical benefit in addition to
safety. In May 2020 the successful completion of Part A and
initiation of Part B was announced.
24 additional patients across five active US sites have now been
treated in Part B of this ongoing study. The safety review
following the first Part B cohort of 10 renal cell carcinoma (RCC)
patients has been completed indicating no dose limiting toxicities.
A total of 12 patients with RCC, nine patients with non-small cell
lung cancer (NSCLC) and three bladder cancer patients have been
enrolled in Part B to date. Recruitment will continue up to a total
of 30 patients in each of these indications.
Target tumor reductions in Part B patients have been observed as
patients reach the first scheduled restaging timepoint (nine
weeks). These include the first signals of anti-tumor activity for
the combination in bladder cancer, adding to the previously
reported activity in RCC and NSCLC in patients in Part A.
Three Part A patients with RCC and NSCLC that were previously
reported to have experienced clinical benefit continue on the
study. Two of these patients have now been treated for over 18
months and have had further target tumor reductions or extended
disease control since the last update. Efficacy of the combination
continues to be evaluated on an ongoing basis.
Following the positive results of Part A in RCC and NSCLC, the
new tumor cohorts added to Part B of the study are now open to
recruitment. Patients with advanced malignancies resistant to ICI
therapy, including triple-negative breast cancer, head and neck
squamous cell carcinoma and microsatellite
instability-high/mismatch repair deficient cancers, are now
eligible for inclusion. Enrolment for the trial is expected to
complete in Q4 2021.
MRx0518 with Radiation in Pancreatic Cancer
Five patients are now enrolled in this Phase I trial. The study
is designed to evaluate safety and efficacy in 15 patients
receiving treatment with MRx0518 and hypofractionated radiation
prior to surgery for pancreatic cancer. This study will generate
valuable data to assess the relationship between systemic and tumor
biomarkers, as well as clinical outcomes. Study treatment is well
tolerated to date. Enrolment continues and we anticipate receiving
initial data from this clinical trial in 2021.
MRx0518 in Neoadjuvant Setting Monotherapy
The previously reported 17 patients in the completed Part A of
this Phase I study continue in the follow up phase for survival
outcomes. Biomarker and safety data from the study were presented
at the Society for Immunotherapy of Cancer (SITC) Annual Meeting
2020, demonstrating systemic immune and tumor microenvironment
modulation following two to four weeks of treatment with MRx0518 .
Additional biomarker analyses are underway to further investigate
the immune response induced by MRx0518. These additional results
may inform an optimization of Part B of this study.
About MRx0518
MRx0518 is single strain Live Biotherapeutic product in
development for the treatment of cancer. It is delivered as an oral
capsule and stimulates the body's immune system, directing it to
produce cytokines and immune cells that are known to attack tumors.
It is currently being evaluated in three clinical trials in cancer
patients. MRx0518-I-001 (NCT03934827) is a neoadjuvant monotherapy
study in a variety of solid tumors and is being conducted at
Imperial College (London, UK). MRx0518-I-002 (NCT03637803) is in
combination with KEYTRUDA (pembrolizumab) in patients who have
previously progressed on anti PD-1 therapies. The Coordinating
Investigator of the study is at The University of Texas MD Anderson
Cancer Center, Houston, USA, with multiple additional sites in the
US. The study is being conducted in collaboration with MSD, the
tradename of Merck & Co., Inc., Kenilworth, NJ, USA.
MRx0518-I-003 (NCT04193904) is in combination with preoperative
radiotherapy in resectable pancreatic cancer.
About 4D pharma
Founded in February 2014, 4D pharma is a world leader in the
development of Live Biotherapeutics, a novel and emerging class of
drugs, defined by the FDA as biological products that contain a
live organism, such as a bacterium, that is applicable to the
prevention, treatment or cure of a disease. 4D has developed a
proprietary platform, MicroRx(R), that rationally identifies Live
Biotherapeutics based on a deep understanding of function and
mechanism.
4D pharma's Live Biotherapeutic products (LBPs) are orally
delivered single strains of bacteria that are naturally found in
the healthy human gut. The Company has six clinical programs,
namely a Phase I/II study of MRx0518 in combination with KEYTRUDA
(pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a
neoadjuvant setting for patients with solid tumors, a Phase I study
of MRx0518 in patients with pancreatic cancer, a Phase I/II study
of MRx-4DP0004 in asthma (NCT03851250), a Phase II study of
MRx-4DP0004 in patients hospitalized with COVID-19 (NCT04363372),
and Blautix(R) in Irritable Bowel Syndrome (IBS) (NCT03721107)
which has completed a successful Phase II trial. Preclinical-stage
programs include candidates for CNS disease such as Parkinson's
disease and other neurodegenerative conditions. The Company has a
research collaboration with MSD, a tradename of Merck & Co.,
Inc., Kenilworth, NJ, USA, to discover and develop Live
Biotherapeutics for vaccines.
In October 2020 4D pharma announced its intention to merge with
Longevity Acquisition Corporation (NASDAQ: LOAC), a special purpose
acquisition company (SPAC), and seek a NASDAQ listing. The merger
is expected to be completed and the NASDAQ listing of 4D pharma
American Depositary Shares (ADSs) under the ticker symbol 'LBPS' is
currently expected to become effective in early 2021, subject to
approval of 4D shareholders and Longevity shareholders, and the SEC
review process.
For more information, refer to https://www.4dpharmaplc.com .
Forward-Looking Statements
This announcement contains "forward-looking statements." All
statements other than statements of historical fact contained in
this announcement, including without limitation statements
regarding timing of enrolments and receipt of clinical data, are
forward-looking statements within the meaning of Section 27A of the
United States Securities Act of 1933, as amended (the "Securities
Act"), and Section 21E of the United States Securities Exchange Act
of 1934, as amended (the "Exchange Act"). Forward-looking
statements are often identified by the words "believe," "expect,"
"anticipate," "plan," "intend," "foresee," "should," "would,"
"could," "may," "estimate," "outlook" and similar expressions,
including the negative thereof. The absence of these words,
however, does not mean that the statements are not forward-looking.
These forward-looking statements are based on the Company's current
expectations, beliefs and assumptions concerning future
developments and business conditions and their potential effect on
the Company. While management believes that these forward-looking
statements are reasonable as and when made, there can be no
assurance that future developments affecting the Company will be
those that it anticipates.
All of the Company's forward-looking statements involve known
and unknown risks and uncertainties, some of which are significant
or beyond its control, and assumptions that could cause actual
results to differ materially from the Company's historical
experience and its present expectations or projections. The
foregoing factors and the other risks and uncertainties that affect
the Company's business, including the risks of delays in enrolments
and the receipt of clinical data and those additional risks and
uncertainties described the documents filed by the Company with the
US Securities and Exchange Commission ("SEC"), should be carefully
considered. The Company wishes to caution you not to place undue
reliance on any forward-looking statements, which speak only as of
the date hereof. The Company undertakes no obligation to publicly
update or revise any of its forward-looking statements after the
date they are made, whether as a result of new information, future
events or otherwise, except to the extent required by law.
Additional Information about the Transaction and Where to Find
it
This press release is being made in respect of a proposed
business combination involving 4D and Longevity. Following the
announcement of the proposed business combination, 4D filed a
registration statement on Form F-4 (the "Registration Statement")
with the SEC. This press release does not constitute an offer to
sell or the solicitation of an offer to buy or subscribe for any
securities or a solicitation of any vote or approval nor shall
there be any sale, issuance or transfer of securities in any
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. The Registration
Statement includes a preliminary prospectus with respect to 4D's
ordinary shares and ADSs to be issued in the proposed transaction
and a proxy statement of Longevity in connection with the merger.
The information in the Registration Statement is not complete and
may be changed. 4D may not sell the ordinary shares referenced in
the Registration Statement until the Registration Statement becomes
effective. The proxy statement/prospectus will be provided to the
Longevity shareholders. 4D and Longevity also plan to file other
documents with the SEC regarding the proposed transaction.
This press release is not a substitute for any prospectus, proxy
statement or any other document that 4D or Longevity may file with
the SEC in connection with the proposed transaction. Investors and
security holders are urged to read the Registration Statement and,
when they become available, any other relevant documents that will
be filed with the SEC carefully and in their entirety because they
will contain important information about the proposed
transaction.
You may obtain copies of all documents filed with the SEC
regarding this transaction, free of charge, at the SEC's website (
www.sec.gov ). In addition, investors and security holders will be
able to obtain free copies of the Registration Statement and other
documents filed with the SEC without charge, at the SEC's website (
www.sec.gov ) or by calling +1-800-SEC-0330.
Participants in the Solicitation
Longevity and its directors and executive officers and other
persons may be deemed to be participants in the solicitation of
proxies from Longevity's shareholders with respect to the proposed
transaction. Information regarding Longevity's directors and
executive officers is available in its annual report on Form 10-K
for the fiscal year ended February 29, 2020, filed with the SEC on
April 30, 2020. Additional information regarding the participants
in the proxy solicitation relating to the proposed transaction and
a description of their direct and indirect interests is contained
in the Registration Statement.
4D and its directors and executive officers may also be deemed
to be participants in the solicitation of proxies from the
shareholders of Longevity in connection with the proposed
transaction. A list of the names of such directors and executive
officers and information regarding their interests in the proposed
transaction is included in the Registration Statement.
Contact Information:
4D pharma
Duncan Peyton, Chief Executive Officer +44 (0)113 895 0130
Investor Relations: ir@4dpharmaplc.com
Investor Relations
Julie Seidel, Stern Investor Relations, Inc. +1-212-362-1200
Julie.seidel@sternir.com
N+1 Singer - Nominated Adviser and Joint Broker +44 (0)20 7496
3000
Philip Davies / Iqra Amin / James Fischer (Corporate
Finance)
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker +44 (0)20 7332
2500
Dominic Wilson / Phil Walker
Image Box Communications
Neil Hunter / Michelle Boxall +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency
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