PDS Biotech: Median Overall Survival announcement
28/12/2022 15:05
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RNS Number : 1163L NetScientific PLC 28 December 2022
RNS: For immediate release
NetScientific plc
("NetScientific" or the "Company")
PDS Biotech Reports Median Overall Survival (OS) of 21 Months in Advanced,
Refractory Cancer Patients Having Few Remaining Treatment Options and with
Reported Historical Survival of 3-4 months
Median OS of 21 months in 29 checkpoint inhibitor (CPI) refractory
HPV16-positive cancer patients in National Cancer Institute-led Phase 2
clinical trial of PDS0101 triple combination
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 expanded interim data in a Phase 2 clinical trial
investigating the PDS0101-based triple combination therapy in advanced human
papillomavirus (HPV)-positive cancers.
The triple combination of PDS0101 with the tumour-targeting IL-12 fusion
protein M9241 (formerly known as NHS-IL12), and bintrafusp alfa, a
bifunctional fusion protein targeting two independent immunosuppressive
pathways (PD-L1 and TGF-β), is being studied in CPI-naïve and CPI-refractory
patients with advanced HPV-positive anal, cervical, head and neck, vaginal,
and vulvar cancers.
All patients in the study had failed prior treatment with chemotherapy and 90%
had failed radiation treatment. The interim efficacy data (n=50) involves 37
HPV16-positive evaluable patients, including 29 patients who have, in
addition, failed treatment with CPIs (CPI refractory). Highlights of the
expanded interim data are as follows and are consistent with the results
presented at American Society of Clinical Oncology (ASCO) Annual Meeting 2022
and prior interim data announced in October:
· Median OS is 21 months in 29 checkpoint inhibitor refractory
patients who received the triple combination. The reported historical median
OS in patients with CPI refractory disease is 3-4 months.
· In CPI naïve subjects, 75% 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.
· Objective response rate (ORR) in CPI refractory patients who
received the optimal dose of the triple combination is 63% (5/8). In current
approaches ORR is reported to be less than 10%.
· ORR in CPI naïve patients with the triple combination is 88%. In
current approaches ORR is reported to be less than 25% with FDA-approved CPIs
in HPV-associated cancers.
· Safety data have not changed since October's update. 48% (24/50) of
patients experienced Grade 3 (moderate) treatment-related adverse events
(AEs), and 4% (2/50) of patients experienced Grade 4 (severe) AEs, compared
with approximately 70% of patients receiving the combination of CPIs and
chemotherapy reporting Grade 3 and higher treatment-related AEs.
Both M9241 and bintrafusp alfa are owned by Merck KGaA, Darmstadt, Germany,
and its affiliates.
Dr Ilian Iliev, CEO of NetScientific, commented:
"We are delighted with this expanded interim data from PDS. The triple
combination Phase 2 trial is being conducted at the prestigious Center for
Cancer Research (CCR) at the National Cancer Institute (NCI), one of the
United States' Institutes of the National Institutes of Health."
Dr Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech said:
"The expanded data continue to demonstrate the durability and tolerability of
the PDS0101-based triple combination therapy in advanced HPV-positive cancers,
an extremely challenging population of refractory and previously untreatable
HPV-positive patients."
A full version of PDS Biotech's announcement can be accessed here:
https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/118-2022-news/752-iotecheportsedianverallurvivalof21ont20221228
(https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/118-2022-news/752-iotecheportsedianverallurvivalof21ont20221228)
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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 tumor specific CD4+
helper and CD8+ killer T cells. To date, our lead Versamune(®) clinical
candidate, PDS0101, has demonstrated the potential to reduce tumors 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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