TIDMNSCI
RNS Number : 3449Z
NetScientific PLC
20 May 2021
NetScientific plc
("NetScientific", the "Group" or the "Company")
PDS Biotech Announces Release of Abstract for PDS0101 in NCI-Led
Phase 2 Clinical Study for Oral Presentation at 2021 ASCO
Meeting
London, UK - 20 May 2021 - NetScientific plc (AIM: NSCI), the
international life sciences and sustainability technology
investment and commercialisation Group, announces that its
portfolio company PDS Biotechnology Corporation (Nasdaq: PDSB)
today announced publication of abstract #2501 by the American
Society of Clinical Oncology (ASCO). The abstract summarizing
interim data from the National Cancer Institute (NCI)-led phase 2
trial has been accepted for oral presentation at the 2021 ASCO
Annual Meeting taking place June 4-8. The presentation, scheduled
for June 7, is expected to include results from a larger sample
than the 14 patients included in the abstract.
Additional data highlights from abstract #2501 include:
-- An overall objective response rate of 71% (10/14) in patients
with refractory HPV16-associated cancers
o 1 complete response (anal cancer)
o 9 partial responses (3 cervical cancer, 2 vulvar/vaginal
cancer, 2 anal cancer, 2 oropharyngeal cancer)
-- 90% of these of these responses are ongoing after a median 5 months of follow up (9/10)
Dr. Lauren Wood, Chief Medical Officer of PDS Biotech commented:
"The achievement of a 71% objective response rate in a difficult to
treat patient population continues to strengthen the evidence of
our novel Versamune(R) platform's potential ability to induce high
levels of tumor-specific CD8+ killer T-cells that attack the cancer
resulting in strong synergy with Bintrafusp alfa and NHS-IL12, thus
leading to effective tumor regression.
"The initial data solidifies our belief that PDS0101's published
preclinical efficacy, when combined with these two
immune-modulating agents, demonstrates the potential to
significantly improve clinical outcomes for patients with advanced,
refractory HPV-associated cancers who have limited treatment
options."
Dr. Ilian Iliev, CEO of NetScientific and Director of PDS
Biotechnology commented: "We are pleased to see the additional data
that further demonstrates the efficacy of the novel Versamune(R)
platform. It represents the significant potential that PDS0101 has
with treating HPV-associated cancers."
NetScientific holds 5.75% of PDS on an undiluted basis.
The full text of the announcement from PDS Biotechnology is
reproduced below and is available online here:
https://www.pdsbiotech.com/investors/news-center/press-releases/press-releases1/113-2021-news/523-iotechnnounceseleaseofbstractfor0101in20210520
###
FLORHAM PARK, N.J., May 20, 2021 (GLOBE NEWSWIRE) -- PDS
Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing novel cancer therapies based on
the Company's proprietary Versamune(R) T-cell activating
technology, today announced publication of abstract #2501 by the
American Society of Clinical Oncology (ASCO). The abstract
summarizing interim data from the National Cancer Institute
(NCI)-led phase 2 trial has been accepted for oral presentation at
the 2021 ASCO Annual Meeting taking place June 4-8. The
presentation, scheduled for June 7, is expected to include results
from a larger sample than the 14 patients included in the
abstract.
Additional data highlights from abstract #2501 include:
-- An overall objective response rate of 71% (10/14) in patients
with refractory HPV16-associated cancers
o 1 complete response (anal cancer)
o 9 partial responses (3 cervical cancer, 2 vulvar/vaginal
cancer, 2 anal cancer, 2 oropharyngeal cancer)
-- 90% of these of these responses are ongoing after a median 5 months of follow up (9/10)
The NCI Center for Cancer Research's Laboratory of Tumor
Immunology and Biology (LTIB) and Genitourinary Malignancies Branch
(GMB) are jointly leading this Phase 2 trial (NCT04287868), which
studies PDS0101 in combination with two investigational
immune-modulating agents: bintrafusp alfa (M7824), a bifunctional
"trap" fusion protein targeting TGF-<BETA> and PD-L1, and
NHS-IL12 (M9241), a tumor-targeting immunocytokine. Bintrafusp alfa
is being jointly developed by Merck KGaA, Darmstadt, Germany, and
GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA,
Darmstadt, Germany.
The trial is evaluating the treatment combination in both
checkpoint inhibitor naïve and refractory patients with advanced
human papillomavirus (HPV)-associated cancers that have progressed
or returned after treatment. Objective response is measured by
radiographic tumor responses according to RECIST 1.1. These
reported data validate the preclinical studies published by the NCI
demonstrating that the complementary mechanisms of action of the
three immunotherapies which involve potent in-vivo HPV16-specific
killer and helper T-cell induction with effective T-cell tumor
infiltration, blocking of immune checkpoints as well as targeting
of TGF-<BETA> resulted in superior tumor regression.
"The achievement of a 71% objective response rate in a difficult
to treat patient population continues to strengthen the evidence of
our novel Versamune(R) platform's potential ability to induce high
levels of tumor-specific CD8+ killer T-cells that attack the cancer
resulting in strong synergy with Bintrafusp alfa and NHS-IL12, thus
leading to effective tumor regression," commented Dr. Lauren Wood,
Chief Medical Officer of PDS Biotech. "The initial data solidifies
our belief that PDS0101's published preclinical efficacy, when
combined with these two immune-modulating agents, demonstrates the
potential to significantly improve clinical outcomes for patients
with advanced, refractory HPV-associated cancers who have limited
treatment options."
There are more than 630,000 cases of HPV-associated malignancies
including cervical, oropharyngeal and anal cancer worldwide
annually. HPV 16 is responsible for most of these cases. About
15-20% of HPV-associated malignancies respond to PD-(L)1
inhibitors. However, for the overwhelming majority of patients who
progress on these immunotherapies there is no effective standard of
care therapy.
The abstract is now available online on the ASCO conference
website: https://am.asco.org/ .
Abstract Number: 2501
Abstract Title: Phase II evaluation of the triple combination of
PDS0101, M9241, and bintrafusp alfa in patients with HPV 16
positive malignancies.
Presenting Author: Julius Strauss, MD, National Cancer
Institute
Session: Developmental Therapeutics-Immunotherapy
Date: June 7, 2021
Time: 3:00 PM-6:00 PM EDT
Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the
Principal Investigator of this phase 2 clinical trial in advanced
HPV-associated cancers. For patients interested in enrolling in
this clinical study, please call NCI's toll-free number
1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email
NCIMO_Referrals@mail.nih.gov, and/or visit the website:
https://trials.cancer.gov .
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing
a growing pipeline of cancer immunotherapies and infectious disease
vaccines based on the Company's proprietary Versamune(R) T-cell
activating technology platform. Our Versamune(R)-based products may
overcome the limitations of current immunotherapy by inducing in
vivo, large quantities of high-quality, highly potent
polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells.
PDS Biotech has developed multiple investigational therapies, based
on combinations of Versamune(R) and disease-specific antigens,
designed to train the immune system to better recognize diseased
cells and effectively attack and destroy them. Our immuno-oncology
product candidates are initially being studied in combination
therapy to potentially enhance efficacy without compounding
toxicity across a range of cancer types. The company's lead
investigational cancer immunotherapy product PDS0101 is currently
in Phase 2 clinical studies in HPV-associated cancers. To learn
more, please visit www.pdsbiotech.com or follow us on Twitter at
@PDSBiotech.
About PDS0101
PDS Biotech's lead candidate, PDS0101, combines the utility of
the Versamune(R) platform with targeted antigens in HPV-expressing
cancers. In partnership with Merck and Co., PDS Biotech is
evaluating a combination of PDS0101 and KEYTRUDA(R) in a Phase 2
study in first-line treatment of recurrent or metastatic head and
neck cancer. PDS Biotech is also conducting two additional Phase 2
studies in advanced HPV-associated cancers and advanced localized
cervical cancer with the National Cancer Institute (NCI) and The
University of Texas MD Anderson Cancer Center, respectively.
###
Further details and the information required in accordance with
the requirements of Article 19(3) of the EU Market Abuse Regulation
No 596/2014 are set out at the end of this announcement.
For more information, please contact:
NetScientific Via Walbrook PR
Ilian Iliev, CEO
WH Ireland (NOMAD, Financial Adviser
and Broker)
Chris Fielding / Darshan Patel +44 (0)20 7220 1666
Walbrook PR +44 (0)20 7933 8780 or netscientific@walbrookpr.com
Nick Rome / Nicholas Johnson / Paul 07748 325 236 / 07884 664 686 / 07980
McManus 541 893
About NetScientific
NetScientific plc (AIM: NSCI) is a holding company, that invests
in, develops, commercialises and realises shareholder value in life
sciences/healthcare, sustainability and technology companies, which
offer significant growth potential predominately in the UK and USA,
as well as globally.
With the acquisition of EMV Capital in August 2020, the Group
doubled its portfolio from 8 to 17 companies, either through direct
subsidiary, balance sheet investment or capital under advisory,
varying from start-up private companies to publicly listed
equities.
NetScientific delivers shareholder returns through a proactive
and hands-on management approach to their 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
transatlantic and growing international presence, providing
attractive expansion prospects.
NSCI can deploy a capital-light investment structure; utilising
the power of the PLC Brand, and the NetScientific balance sheet to
anchor future investments and achieve a multiplier effect by
attracting 3rd party investment for the portfolio companies.
NetScientific is headquartered in London, United Kingdom, and
was admitted to trading on AIM, a market operated by the London
Stock Exchange, in 2013 (website: www.netscientific.net ).
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