NEW YORK, Feb. 8, 2021 /PRNewswire/ -- Longevity
Acquisition Corporation (NASDAQ: LOAC) (the "Company"), a
publicly-traded special purpose acquisition company, announced
today that on February 8, 2021, 4D
pharma plc (AIM: DDDD) ("4D pharma"), a pharmaceutical company
leading the development of Live Biotherapeutic products ("LBPs") -
a novel class of drug derived from the microbiome, and a business
combination target of LOAC, has 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 LOAC
LOAC is a blank check company, also commonly referred to as a
Special Purpose Acquisition Company, or SPAC, formed for the
purpose of acquiring, engaging in a share exchange, share
reconstruction and amalgamation, purchasing all or substantially
all of the assets of, entering into contractual arrangements, or
engaging in any other similar business combination with one or more
businesses or entities. LOAC is contemplating a proposed business
combination with 4d pharma plc (AIM: DDDD), a public limited
company incorporated under the laws of England and Wales pursuant to an agreement and plan of
merger dated October 21, 2020 as
disclosed in a Form 8-K filed with the Securities and Exchange
Commission on October 22, 2020. LOAC
is sponsored by Whale Management Corporation, a BVI business
company with limited liability.
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 and the exhibits hereto include
"forward-looking statements" within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995 and within the meaning of Section 27a of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of
1934, as amended. Any actual results may differ from expectations,
estimates and projections presented or implied and, consequently,
you should not rely on these forward-looking statements as
predictions of future events. Words such as "expect," "estimate,"
"project," "budget," "forecast," "anticipate," "intend," "plan,"
"may," "will," "could," "should," "believes," "predicts,"
"potential," "continue," and similar expressions are intended to
identify such forward-looking statements. These forward-looking
statements include, without limitation, LOAC's expectations with
respect to future performance, anticipated financial impacts of the
proposed business combination, approval of the business combination
transactions by security holders, the satisfaction of the closing
conditions to such transactions and the timing of the completion of
such transactions.
Additional Information About the Proposed Business
Combination and Where To Find It
The proposed business combination will be submitted to
stockholders of LOAC for their consideration and approval at a
special meeting of stockholders. 4D pharma has filed a preliminary
registration statement (the "Registration Statement") with the SEC
on November 25, 2020, and LOAC filed
a preliminary proxy statement in connection with LOAC's
solicitation of proxies for the vote by LOAC's stockholders in
connection with the proposed business combination and other matters
as described in the proxy statement, as well as the preliminary
prospectus relating to the offer of the securities to be issued to
LOAC's stockholders in connection with the completion of the
business combination. After the Registration Statement has been
declared effective, LOAC will mail a definitive proxy statement and
other relevant documents to its stockholders as of the record date
established for voting on the proposed business combination. LOAC's
stockholders and other interested persons are advised to read the
preliminary proxy statement and any amendments thereto and, once
available, the definitive proxy statement / consent solicitation /
prospectus, in connection with LOAC's solicitation of proxies for
its special meeting of stockholders to be held to approve, among
other things, the proposed business combination, because these
documents will contain important information about LOAC, 4D pharma
and the proposed business combination. Stockholders may also obtain
a copy of the preliminary proxy statement / prospectus, or
definitive proxy statement / prospectus once available, as well as
other documents filed with the SEC regarding the proposed business
combination and other documents filed with the SEC by LOAC, without
charge, at the SEC's website located at www.sec.gov or by directing
a request to:
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Advantage Proxy,
Inc.
P.O. Box 13581
Des Moines, WA 98198
Attn: Karen Smith
Toll Free: (877) 870-8565
Collect: (206) 870-8565
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Longevity Acquisition Corporation
Yongda International Tower No. 2277
Longyang Road, Pudong District, Shanghai
People's Republic of China
(86) 21-60832028
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This press release does not constitute an offer to sell or the
solicitation of an offer to buy any securities, or a solicitation
of any vote or approval, nor shall there be any sale 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. No offering of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the U.S. Securities Act of 1933, as
amended.
INVESTMENT IN ANY SECURITIES DESCRIBED HEREIN HAS NOT BEEN
APPROVED OR DISAPPROVED BY THE SEC OR ANY OTHER REGULATORY
AUTHORITY NOR HAS ANY AUTHORITY PASSED UPON OR ENDORSED THE MERITS
OF THE OFFERING OR THE ACCURACY OR ADEQUACY OF THE INFORMATION
CONTAINED HEREIN. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL
OFFENSE.
Contact:
Matthew Chen
Longevity Acquisition Corporation
+ (86) 21-60832028
mchen@lonacq.com
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SOURCE Longevity Acquisition Corporation