TIDMNSCI
RNS Number : 5397L
NetScientific PLC
03 January 2023
RNS: For immediate release
NetScientific plc
("NetScientific" or the "Company")
PDS Biotech Announces Exclusive Global License Agreement for
Investigational IL-12 Tumour-Targeted Cytokine from Merck KGaA,
Darmstadt, Germany
PDS Biotech bolsters immuno-oncology portfolio with a
clinical-stage product synergistic with its Versamune(R)
platform
NetScientific Plc (AIM: NSCI), the investment and
commercialisation group with an international portfolio of
innovative life science, sustainability and technology companies,
reports that its portfolio company, PDS Biotechnology Corporation
(Nasdaq: PDSB), a clinical-stage immunotherapy company developing a
growing pipeline of targeted immunotherapies for cancer and
infectious disease, today announced an exclusive global license
agreement with Merck KGaA, Darmstadt, Germany for the
tumour-targeting IL-12 fusion protein M9241 (formerly known as
NHS-IL12), which will join the pipeline as PDS0301.
M9241 appears to enhance the proliferation, potency, and
longevity of T cells in the tumour. The combination of Versamune(R)
and IL-12 is patented by PDS Biotech and is designed to overcome
tumour immune suppression utilizing a different mechanism from
checkpoint inhibitors.
Under the terms of the agreement, PDS Biotech will receive from
Merck KGaA, Darmstadt, Germany an exclusive license to M9241. PDS
Biotech will assume responsibility for future development,
commercialization, and manufacturing of M9241.
Under the terms of the agreement, Merck KGaA, Darmstadt, Germany
will receive an upfront cash payment of $5 million and will be
entitled to up to $11 million in development and regulatory
milestone payments including first commercial sales for the first 2
indications, and up to $105 million in commercial milestones, and a
10% royalty on future sales of M9241 with standard step-down
provisions. Merck KGaA will receive 378,787 shares of PDS Biotech's
common stock having a value of $5 million, based on the closing
price of PDS Biotech's common stock on December 30, 2022.
Dr Frank Bedu-Addo, President and Chief Executive Officer of PDS
Biotech, said:
"We are pleased to have partnered with Merck KGaA, Darmstadt,
Germany to advance the development of M9241, a highly innovative
cytokine therapy. Under the licensing arrangement between Merck
KGaA, Darmstadt, Germany and PDS Biotech, assumption of an equity
stake by Merck KGaA, Darmstadt, Germany in PDS Biotech further
confirms the potential of the Versamune(R) platform and the data
generated to date with this combination therapy. I would like to
thank the Merck KGaA, Darmstadt, Germany team for their support of
PDS Biotech's mission to potentially offer more cancer patients
improved treatment options."
M9241 was studied in a novel triple combination at the National
Cancer Institute in a Phase 2 trial (NCT04287868) in combination
with PDS0101, a Versamune(R) based HPV16-targeted immunotherapy,
and bintrafusp alfa, a bifunctional fusion protein targeting two
independent immunosuppressive pathways (PD-L1 and
TGF-<BETA>). The triple combination was studied in checkpoint
inhibitor (CPI)-naïve and -refractory patients with advanced
HPV-positive anal, cervical, head and neck, vaginal, and vulvar
cancers who have failed prior therapy.
Data highlights for patients who had failed prior treatments
including CPIs:
-- Median overall survival for treated patients is 21 months in
29 CPI refractory patients. The reported historical median OS in
patients with CPI refractory disease is 3-4 months.
-- 63% (5/8) of treated patients with the optimal dose
combination had significant tumour shrinkage of over 30% (objective
response). With the standard of care, the reported percentage of
patients having an objective response is less than 10%.
-- 79% (11/14) of treated patients demonstrated a greater than
two-fold increase in HPV16-targeted T cells.
Results for patients who had failed prior treatments but were
CPI-naïve also continue to appear to be encouraging:
-- 88% (7/8) of CPI naïve patients had an objective response.
-- 38% (3/8) of responders had a complete response.
-- In CPI naïve subjects, 75% (6/8) remain alive at a median
follow-up of 27 months. As a result, median OS has not yet been
reached. Historically median OS for similar patients with platinum
experienced CPI naïve disease is 7-11 months.
PDS Biotech has a scheduled meeting with the Food and Drug
Administration (FDA) to discuss a registrational trial for
investigating the triple combination of M9241, PDS0101 and a
checkpoint inhibitor in recurrent/metastatic HPV-positive
cancers.
Dr Lauren V. Wood, Chief Medical Officer at PDS Biotech,
commented:
"M9241 seems to be unique in its ability to target the tumour's
microenvironment and appears to further promote proliferation of
Versamune(R)-induced T cells in the tumours while also potentially
enhancing the killing potency of the T cells. With the addition of
M9241 to our Versamune(R)-based pipeline products, our goal is to
develop and achieve checkpoint inhibitor-agnostic and independent
combinations in advanced cancers. We look forward to expanding
clinical development of our novel investigational combination
products."
Dr Ilian Iliev, CEO of NetScientific, also commented:
"This is another important milestone in PDS' development,
working with leading global pharma companies in enhancing its
platform and pipeline commercial potential. After a successful
2022, the PDS team is off to a great start for 2023."
A full version of PDS Biotech's announcement can be accessed
here:
https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/763-iotechnnouncesxclusivelobalicensegreementfo20230103
-Ends-
For more information, please contact:
#NetScientific
Ilian Iliev, CEO Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel / Enzo Aliaj +44 (0)20 7220 1666
Belvedere Communications
John West / Llew Angus +44 (0) 203 008 6867
Email: nsci@belvederepr.com
About NetScientific
NetScientific plc (AIM: NSCI) is an investment and
commercialisation group with an international portfolio of
innovative life science, sustainability and technology
companies.
NetScientific identifies, invests in, and builds high growth
companies in the UK and internationally. The company adds value
through the proactive management of its portfolio, progressing to
key value inflection points, and delivering investment returns
through partial or full liquidity events.
NetScientific differentiates itself by employing a capital-light
investment approach, making judicial use of its balance sheet and
syndicating investments through its wholly owned VC subsidiary, EMV
Capital. The group secures a mixture of direct equity stakes and
carried interest stakes in its portfolio of companies, creating a
lean structure that can support a large portfolio.
NetScientific is headquartered in London, United Kingdom, and is
admitted to trading on AIM, a market operated by the London Stock
Exchange.
www.netscientific.net
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing
a growing pipeline of targeted cancer and infectious disease
immunotherapies based on our proprietary Versamune(R) and
Infectimune(TM) T cell-activating technology platforms. We believe
our targeted Versamune(R) based candidates have the potential to
overcome the limitations of current immunotherapy by inducing large
quantities of high-quality, potent polyfunctional tumour specific
CD4+ helper and CD8+ killer T cells. To date, our lead Versamune(R)
clinical candidate, PDS0101, has demonstrated the potential to
reduce tumours and stabilize disease in combination with approved
and investigational therapeutics in patients with a broad range of
HPV-positive cancers in multiple Phase 2 clinical trials. Our
Infectimune(TM) based vaccines have also demonstrated the potential
to induce not only robust and durable neutralizing antibody
responses, but also powerful T cell responses, including
long-lasting memory T cell responses in pre-clinical studies to
date. To learn more, please visit www.pdsbiotech.com or follow us
on Twitter at @PDSBiotech.
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