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 announced a
clinical trial collaboration and supply agreement with Merck KGaA,
Darmstadt, Germany and Pfizer Inc. for BAVENCIO® (avelumab), the
first and only immunotherapy approved as a first-line maintenance
treatment for patients with locally advanced or metastatic
urothelial carcinoma. BAVENCIO is co-developed and
co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer
Inc.
Under the collaboration, 4D pharma intends to commence a
clinical trial in 2021 to evaluate BAVENCIO in combination with
MRx0518 as a first-line maintenance therapy for patients with
locally advanced or metastatic urothelial carcinoma that has not
progressed with first-line platinum-containing chemotherapy.
“With this second clinical trial collaboration for MRx0518 with
a leading immune checkpoint inhibitor, 4D is able to evaluate
MRx0518 in a new combination and earlier treatment setting.
Following the promising data already generated in combination with
checkpoint inhibitor pembrolizumab in refractory patients, and
MRx0518 monotherapy data demonstrating single agent
immuno-modulation presented last year at SITC, this collaboration
allows us to continue to build a broad understanding of the safety
and efficacy of MRx0518 across a range of solid tumors and stages
of disease,” said Duncan Peyton, Chief Executive Officer, 4D
pharma. “The combination of MRx0518 with BAVENCIO has the potential
to further enhance the positive clinical outcomes achieved by
BAVENCIO for the significant number of patients in this treatment
setting.”
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
tumours. It is currently being evaluated in three clinical trials
in patients with cancer. MRx0518-I-001 is a neoadjuvant monotherapy
study in a variety of solid tumours and is being conducted at
Imperial College (London, UK). MRx0518-I-002 is in combination with
KEYTRUDA® (pembrolizumab) in patients whose disease has 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 is in
combination with preoperative radiotherapy in resectable pancreatic
cancer. A fourth clinical trial of MRx0518 in combination with
BAVENCIO® (avelumab) in the first-line maintenance setting for
urothelial carcinoma, conducted in collaboration with Merck KGaA,
Darmstadt, Germany and Pfizer Inc., is expected to initiate in
2021.
Avelumab Approved Indications
Avelumab (BAVENCIO®) is indicated in the US for the maintenance
treatment of patients with locally advanced or metastatic
urothelial carcinoma (UC) that has not progressed with first-line
platinum-containing chemotherapy. BAVENCIO is also indicated for
the treatment of patients with locally advanced or metastatic UC
who have disease progression during or following
platinum-containing chemotherapy, or have disease progression
within 12 months of neoadjuvant or adjuvant treatment with
platinum-containing chemotherapy.
Avelumab in combination with axitinib is approved in the US for
the first-line treatment of patients with advanced renal cell
carcinoma (RCC).
In the US, the FDA granted accelerated approval for BAVENCIO for
the treatment of adults and pediatric patients 12 years and older
with metastatic Merkel cell carcinoma (MCC). This indication is
approved under accelerated approval based on tumor response rate
and duration of response. Continued approval may be contingent upon
verification and description of clinical benefit in confirmatory
trials.
Avelumab Important Safety Information from the US
FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO®) include
immune-mediated adverse reactions (such as pneumonitis and
hepatitis including fatal cases, colitis, endocrinopathies,
nephritis, and other immune-mediated adverse reactions as a single
agent or in combination with axitinib which can be severe and have
included fatal cases), infusion-related reactions, hepatotoxicity
in combination with axitinib, major adverse cardiovascular events
(MACE) in combination with axitinib which can be severe and have
included fatal cases, and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients)
in patients treated with BAVENCIO® monotherapy include fatigue,
musculoskeletal pain, diarrhea, nausea, infusion-related reaction,
peripheral edema, decreased appetite, urinary tract infection and
rash. Common adverse reactions (reported in at least 20% of
patients) in patients receiving BAVENCIO® in combination with
axitinib include diarrhea, fatigue, hypertension, musculoskeletal
pain, nausea, mucositis, palmar-plantar erythrodysesthesia,
dysphonia, decreased appetite, hypothyroidism, rash,
hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade
3-4 hematology laboratory value abnormalities reported in at least
10% of patients with Merkel cell carcinoma treated with BAVENCIO®
monotherapy include lymphopenia; in patients receiving BAVENCIO® in
combination with axitinib, grade 3-4 clinical chemistry
abnormalities include blood triglyceride increased and lipase
increased.
For full US Prescribing Information and Medication Guide for
BAVENCIO®, please see http://www.BAVENCIO.com.
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®, 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 programmes,
namely a Phase I/II study of MRx0518 in combination with KEYTRUDA®
(pembrolizumab) in solid tumours, a Phase I study of MRx0518 in a
neoadjuvant setting for patients with solid tumours, a Phase I
study of MRx0518 in patients with pancreatic cancer, a Phase I/II
study of MRx-4DP0004 in asthma, a Phase II study of MRx-4DP0004 in
patients hospitalised with COVID-19, and Blautix® in Irritable
Bowel Syndrome (IBS) which has completed a successful Phase II
trial. Preclinical-stage programmes 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 press release contains "forward-looking statements." All
statements other than statements of historical fact contained in
this announcement, including without limitation statements
regarding timing of the clinical trial 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 the
commencement of the clinical trial 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210208005074/en/
4D 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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