NEW YORK, Feb. 3, 2021 /PRNewswire/ -- Longevity
Acquisition Corporation (NASDAQ: LOAC) (the "Company"), a
publicly-traded special purpose acquisition company, announced
today that on February 3, 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 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®
(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 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 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® 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 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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or
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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