TIDMNSCI
RNS Number : 5769F
NetScientific PLC
07 November 2022
For immediate release
NetScientific plc
("NetScientific" or the "Company")
PDS Biotech Update
PDS Biotech announces presentation of data for PDS0101 at
Society for Immunotherapy of Cancer
NetScientific Plc (AIM: NSCI), the international life sciences
and sustainability technology investment and commercialisation
Group, is delighted to report that its portfolio company, PDS
Biotechnology Corporation (Nasdaq: PDSB), has announced upcoming
presentations of clinical data from two Phase 2 clinical trials of
PDS0101.
PDS0101 is PDS Biotech's lead candidate being developed as a
potential treatment for HPV-positive cancers.
The presentations will be made at the 37th Annual Meeting for
the Society for Immunotherapy of Cancer being held from 8 to 12
November 2022 in the United States. The Society for Immunotherapy
of Cancer is the world's leading member society of medical
professionals dedicated to advancing cancer immunotherapy and
biological therapy.
First Abstract and Highlights
The first abstract accepted for presentation titled "IMMUNOCERV,
an ongoing Phase II trial combining PDS0101, an HPV-specific T cell
immunotherapy, with chemotherapy and radiation for treatment of
locally advanced cervical cancers," highlights data from The
University of Texas MD Anderson Cancer Center-led IMMUNOCERV Phase
2 clinical trial (NCT04580771).
The study is investigating PDS0101 in combination with
standard-of-care chemoradiotherapy (CRT) for the potential
treatment of cervical cancer in patients with large tumors over 5cm
in size and/or cancer that has spread to the lymph nodes (lymph
node metastasis).
Highlights from the study include:
-- 17 patients have been enrolled in the trial.
-- 8 of the 17 patients had completed a Day 170 post-treatment
Positron Emission Tomography, Computed Tomography (PET CT) scan to
assess the status of the cancer.
-- 87.5% (7/8) of patients treated with the combination of
PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by
PET CT. One patient who received 3 of the 5 scheduled doses of
PDS0101 showed signs of residual disease.
-- In comparison, 74.1% (40/54) of locally advanced patients who
received CRT alone and were monitored at The University of Texas MD
Anderson Cancer Center on a prospective protocol independent of
IMMUNOCERV had a CR on PET CT at Day 170.
-- The 1-year overall survival is 100% (8/8) in patients treated
with the combination of PDS0101 and CRT.
-- The observed 1-year disease-free survival rate for IMMUNOCERV patients is 87.5% (7/8).
-- Patients treated with the combination of PDS0101 and CRT had a 71% increase in multi-cytokine-inducing(polyfunctional) killer (CD8+) T cells within the tumors from baseline to end of treatment (38% to 65%). This increase in activated T cells was not seen in patients receiving standard-of-care CRT.
-- Toxicity of PDS0101 was limited to low-grade local injection site reactions.
Second Abstract and Highlights
The second abstract, titled "Immune Correlates Associated with
Clinical Benefit in Patients with Checkpoint Refractory
HPV-Associated Malignancies Treated with Triple Combination
Immunotherapy," reports data from the Phase 2 triple combination
trial (NCT04287868), which is being led by the Center for Cancer
Research at the National Cancer Institute (NCI), part of the
National Institutes of Health.
The study is investigating PDS0101 in combination with two
investigational immune-modulating agents: M9241, a tumor-targeting
IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional
checkpoint inhibitor (PD-L1/ TGF-<BETA>). The triple
combination is being 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. For most patients who are CPI refractory, there is no
effective therapy. The immune correlates before and after treatment
in the CPI refractory patient population were studied.
Highlights from the study include:
-- A more than two-fold increase in HPV16-specific T cells in
the blood of 79% (11/14 tested) of the evaluated patients.
-- Immune responses were associated with increases in natural
killer cells, soluble granzyme B (associated with active killer T
cells), IFN-<GAMMA>, TNF-<ALPHA>, etc., two weeks after
the first treatment cycle thus signaling a pro-inflammatory
response.
-- These immunogenicity findings highlight the potential role of
the combination in altering immune suppressive forces, and support
previously announced results documenting promising clinical
outcomes in the CPI-refractory population receiving the triple
combination.
Dr Ilian Iliev, CEO of NetScientific, said that:
"We are delighted that research describing PDS0101's therapeutic
potential will be highlighted in two presentations at the
prestigious and respected Annual Meeting of the Society of
Immunotherapy of Cancer in Boston, Massachusetts.
"These presentations set out remarkable progress in the fight
against HPV-positive cancers, and PDS Biotech should be enormously
proud of their achievements. We wish them well at the Annual
Meeting, and encourage attendees to engage with the team and their
findings as they continue their all-important work to battle
various diseases."
Dr Frank Bedu-Addo, CEO of PDS Biotech, said that:
"Taken together, the data being presented demonstrate the
potential ability of PDS0101 to elicit in patients the right type
and quality of therapeutic immune response. This seems to allow
PDS0101 to work in combination with a variety of therapeutic agents
to generate clinical responses that appear to exceed current
standards of care and allow for improved outcomes in patients with
HPV-positive cancers. We look forward to continued progression of
our Phase 2 clinical trials evaluating the efficacy, safety and
tolerability of PDS0101 in combination with other therapies."
A full version of PDS Biotech's announcement can be accessed
here: PDS Biotech Announces Presentation of Preliminary PDS0101
Efficacy, Safety, and Immunology Data at (campaign-archive.com)
This announcement contains inside information for the purposes
of Article 7 of the UK version of Regulation (EU) No 596/2014 which
is part of UK law by virtue of the European Union (Withdrawal) Act
2018, as amended ("MAR"). Upon the publication of this announcement
via a Regulatory Information Service, this inside information is
now considered to be in the public domain.
-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: langus@belvederepr.com
About NetScientific
NetScientific Plc ("NSCI") is an active holding Company that
proactively invests in a global portfolio of companies across the
healthcare, life science, ESG, and deep technology sectors.
NetScientific delivers shareholder returns through a proactive and
hands-on management approach to its portfolio companies;
identifying, investing in, and helping to build game-changing
companies. The Group targets value inflection points and the
release of value through partial or full exits from trade sales,
public listings, or equity sales. The Company has a strong
Trans-Atlantic and growing international presence, providing
attractive expansion prospects.
The Company differentiates itself by employing a capital-light
investment approach, making use of its wholly owned subsidiary, EMV
Capital's network of private, corporate, and institutional
investors. By syndicating investment and making minimal use of its
balance sheet, the Company is able to secure direct stakes, as well
as carried interest stakes, in its portfolio. This ultimately
creates a structure that can support a large portfolio with a
limited balance sheet.
NetScientific is headquartered in London, United Kingdom, and
was admitted to trading on AIM, a market operated by the London
Stock Exchange, in 2013.
www.netscientific.net
About PDS Biotech
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-expressing 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.
https://www.pdsbiotech.com/
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