PDS Announces Exclusive Global License Agreement
03/01/2023 13:31
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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® 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® 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® 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® based HPV16-targeted immunotherapy, and bintrafusp alfa, a
bifunctional fusion protein targeting two independent immunosuppressive
pathways (PD-L1 and TGF-β). 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®-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®-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 (mailto: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 (http://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(®) and Infectimune™ T cell-activating technology
platforms. We believe our targeted Versamune(®) 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(®) 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™ 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 (http://www.pdsbiotech.com) or follow us on Twitter
at @PDSBiotech.
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