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 the publication of pre-clinical research relating to its
second-generation immuno-oncology LBP MRx1299 improving the
activity of CAR-T.
The research, conducted in collaboration with the
Philipps-University Marburg, Germany, and Universitätsklinikum
Würzburg, Germany, and published in Nature Communications,
demonstrates the ability of the bacterium Megasphaera massiliensis
or its short chain fatty acid (SCFA) metabolite pentanoate to
enhance the anti-tumor activity of cytotoxic T lymphocytes (CTL)
and CAR-T therapies in animal models of cancer, resulting in better
tumor clearance.
4D pharma identified M. massiliensis MRx1299 using its MicroRx®
platform and previously showed MRx1299 to have specific histone
deacetylase (HDAC) inhibitory activity and be a rare prolific
producer of pentanoate. This led to discussions with the lab of Dr.
Alexander Visekruna, corresponding author on the recent
publication, due to their work investigating the effects of SCFAs
on immune cell subsets.
“Our existing clinical
oncology programs, such as the study of MRx0518 and Keytruda in
refractory patients, have shown the important role our live
biotherapeutics have to play in the fight against cancer in
combination with immunotherapies. Using the MicroRx platform we
have now shown we have the potential to improve the efficacies of
cell therapies such as CAR-T,” commented Dr. Imke Mulder, Research Director,
4D pharma. “This demonstrates not only the importance of Live
Biotherapeutics as a new modality poised to revolutionize the
treatment of a wide range of cancers, but also the power of our
MicroRx platform to continue making significant discoveries and
advances in this field.”
“Collectively, these results
suggest that low-abundant commensal bacterial species such as M.
massiliensis and their selective metabolites such as pentanoate,
rather than broadly distributed and abundant commensals, may be
used as specific microbial biotherapeutics to enhance anti-tumor
immunity and increase the efficacy of CAR-T therapy for treating
tumors,” commented Dr
Alexander Visekruna of the Institute for Medical Microbiology and
Hospital Hygiene at Philipps-University Marburg. “Combined
therapies including immune checkpoint inhibitors or CAR-T and
simultaneous provision of low-abundant bacteria synthesizing
specific metabolites as an adjunctive agent may be therapeutically
useful.”
Luu et al., Nature
Communications, ‘Microbial short-chain fatty acids modulate CD8+ T
cell responses and improve adoptive immunotherapy for
cancer’
https://www.nature.com/articles/s41467-021-24331-1
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 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.
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.
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 and their ability to
impact CAR-T treatment outcomes, 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 historical
experience and its present expectations or projections. The
foregoing factors and the other risks and uncertainties that affect
the Company's business, including the risks relating to the
activity and efficacy of its Live Biotherapeutic drug candidates,
and those additional risks and uncertainties described the
documents filed by the Company with the US Securities and Exchange
Commission ("SEC"), should be carefully considered. 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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