- Primary Efficacy Endpoint Met Early in Renal
Cell Carcinoma Group in Part B of Study
- Company to Host Conference Call and Webcast
Today March 23, 10:00 am EST (2:00 pm GMT)
4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical
company leading the development of Live Biotherapeutic products
(LBPs), a novel class of drug derived from the microbiome, today
announces that in Part B of its signal finding study of MRx0518 in
combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab)
in patients with solid tumors that have progressed on a prior
immune checkpoint inhibitor (ICI), the renal cell carcinoma (RCC)
group has met its primary efficacy endpoint ahead of enrollment
completion.
The ongoing study is being conducted in heavily pre-treated
metastatic patients with solid tumors who have previously
experienced clinical benefit on prior ICI therapy and subsequently
developed progressive disease. The study is being conducted in
collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ,
USA). The primary efficacy endpoint for Part B of the study is more
than three out of 30 patients per tumor group achieving clinical
benefit, defined as complete response, partial response, or stable
disease for at least six months.
Part B of the study has to date enrolled 20 patients with RCC,
of which four out of the first 16 evaluable patients have achieved
clinical benefit, each having achieved at least 6 months of stable
disease. To date, Part B of the study has enrolled 47 patients of
up to a total of 120 patients with RCC, non-small cell lung cancer,
bladder cancer, and head and neck squamous cell carcinoma. MRx0518
continues to be safe and well tolerated.
“Today’s results in renal cell carcinoma, meeting the predefined
primary efficacy endpoint early in this difficult to treat
population, marks another important step forward for MRx0518 and
the increasing importance of the microbiome in cancer treatment,”
commented Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma.
“Meeting the primary efficacy endpoint for this group is crucial
for the future development of MRx0518, and these data are highly
informative for our strategy going forward as we determine next
steps in RCC.”
4D pharma intends to discuss next steps with partners and its
Genitourinary Cancers Advisory Board regarding the development path
of MRx0518 and a potentially pivotal study in patients with
ICI-refractory RCC. 4D pharma will continue to recruit patients
into the ongoing study of MRx0518 and Keytruda in RCC and the three
tumor groups, with potential expansion into other types of ICI
resistance.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
Conference Call & Webcast Information 4D pharma will
host a conference call and live webcast on Wednesday, March 23,
2022, at 10:00 am ET (2:00 pm GMT) to discuss the interim results
of the Phase I/II study of the combination of MRx0518 and Keytruda
for the treatment of renal cell carcinoma.
4D pharma management will be joined by key opinion leaders
(KOLs) Dr. Petros Grivas, Associate Professor Clinical Research
Division at the Fred Hutchinson Cancer Research Center, and Dr.
Scott T. Tagawa, Professor of Medicine and Urology at Weill Cornell
Medicine, both members of the 4D pharma’s Genitourinary Cancers
Advisory Board.
To access the live webcast, please visit the ‘Events’ section of
the 4D pharma website. To access audio only, please dial (866)
939-3921 (United States) and (678) 302-3550 (International) and
reference Confirmation Number 50287940. A replay of the webcast and
accompanying slides will be available on the 4D pharma website
following the event.
About 4D pharma 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 pharma 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 five 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, and Blautix® in irritable bowel syndrome
(IBS) which has completed a successful Phase II trial. A Phase I
study of MRx0005 and MRx0029 in patients with Parkinson’s disease
is expected to commence in 2022. Additional preclinical-stage
programs include candidates for CNS disease, immune-inflammatory
conditions and cancer. The Company has a research collaboration
with MSD (Merck & Co., Inc., Kenilworth, NJ, USA), to discover
and develop Live Biotherapeutics for vaccines.
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 the efficacy of Live
Biotherapeutics including MRx0518, the informative nature of the
data for the Company’s strategy, the Company’s next steps with its
partners and the potential expansion of the study into other types
of ICI resistance, 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 present
expectations or projections. The foregoing factors and the other
risks that could cause actual results to differ materially include
risks relating to the efficacy of its Live Biotherapeutic drug
candidates including MRx0518, the risk that the Company changes its
expected strategy and plans, risk related to safety of
investigational therapeutics, clinical development risk, and those
additional risks and uncertainties described in the documents filed
by the Company with the US Securities and Exchange Commission
("SEC"). 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220323005207/en/
4D pharma Investor Relations ir@4dpharmaplc.com
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