TIDMDDDD
RNS Number : 6769F
4d Pharma PLC
23 March 2022
4D pharma Announces Positive Interim Results from the Phase I/II
Study of the Combination of MRx0518 and KEYTRUDA(R) (pembrolizumab)
for the Treatment of Renal Cell Carcinoma
- 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)
Leeds, UK, March 23, 2022 - 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(R) (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(R) 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(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 five clinical programs,
namely a Phase I/II study of MRx0518 in combination with
KEYTRUDA(R) (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(R) 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 .
Contact Information:
4D pharma
Investor Relations ir@4dpharmaplc.com
Singer Capital Markets - Nominated Adviser and Joint Broker
Philip Davies / James Fischer (Corporate Finance) +44 (0)20 7496
3000
Tom Salvesen (Corporate Broking)
Bryan Garnier & Co. Limited - Joint Broker
Dominic Wilson +44 (0)20 7332 2500
Stern Investor Relations
Julie Seidel +1-212-362-1200
julie.seidel@sternir.com Julie.seidel@sternir.com
Image Box Communications
Neil Hunter / Michelle Boxall +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency
6 Degrees
Lynne Dardanell +1-336-202-9689
ldardanell@6degreespr.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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCUURURURUOUUR
(END) Dow Jones Newswires
March 23, 2022 03:00 ET (07:00 GMT)
4d Pharma (LSE:DDDD)
Historical Stock Chart
From Mar 2024 to Apr 2024
4d Pharma (LSE:DDDD)
Historical Stock Chart
From Apr 2023 to Apr 2024