TIDMNSCI
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-<BETA>), 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
-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 tumor specific
CD4+ helper and CD8+ killer T cells. To date, our lead Versamune(R)
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(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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