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RNS Number : 7844O
4d Pharma PLC
02 February 2023
4D pharma plc (in administration)
4D pharma Announces Updated Results from the Renal Cell
Carcinoma Cohort of the Phase I/II Study of the Combination of
MRx0518 and KEYTRUDA(R) (pembrolizumab)
- Further to prior announcement of having met the primary
efficacy endpoint, an additional patient is confirmed as having a
response
- Strengthens strategic focus on developing MRx0518 in IO
combinations in RCC
Leeds, UK, February 2, 2023 - 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 updated clinical data from 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 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 . In March 2022, it was announced
that 4 patients in the RCC cohort had experienced durable stable
disease.
At the time 4D pharma plc was placed into administration it was
agreed that patient recruitment into the study would be placed on
temporary pause but patients who had already started treatment
would be allowed to continue. There were 2 Part B RCC patients on
treatment at the time of administration.
Today, 4D pharma is pleased to announce that one of these
patients is experiencing a partial response. Part B of the study
has to date enrolled 22 patients with RCC, of which 5 out of 20
evaluable patients have achieved clinical benefit. To date, Part B
of the study has enrolled 51 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 and 5 patients are continuing on treatment.
The 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).
"Despite recent setbacks in the microbiome field experienced by
other companies and the limitations on patient recruitment as a
result of the administration, we are delighted that patients
continue to benefit from the trial treatment. We continue to build
on the body of evidence for the future development of MRx0518 and
4D's approach to Live Biotherapeutics" commented Dr. Alex
Stevenson, Chief Scientific Officer, 4D pharma. "Together with the
clinical, safety and biomarker data we have generated in the wider
MRx018 programme, it is clear that there is an opportunity to take
MRx0518 into earlier lines of treatment to improve outcomes with
immunotherapy. While the safety and tolerability of MRx0518 lends
itself to multiple combinations and indications, the data we have
generated in RCC suggests that this provides our most viable route
to market."
4D pharma is in discussion regarding next steps for this study
and future pivotal studies with partners and Key Opinion
Leaders.
KEYTRUDA(R) is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
On 24 June 2022, David Pike and James Clark of Interpath
Advisory were appointed as administrators of 4D Pharma plc. The
administrators make no statement or representation in respect of
the announcement.
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
4Dpharma@interpathadvisory.com
Singer Capital Markets - Nominated Adviser and Joint Broker
Philip Davies / James Fischer (Corporate Finance) +44 (0)20 7496
3000
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 its Live Biotherapeutics including
MRx0006, use of the MicroRx(R) platform to identify candidates, and
the safety and efficacy of Live Biotherapeutics for the treatment
of conditions of the central nervous system (CNS), 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 MRx0006, risk related to safety of
investigational therapeutics, pre-clinical and 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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END
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