TIDMNSCI
RNS Number : 3115Z
NetScientific PLC
16 May 2019
NetScientific plc
("NetScientific" or the "Company")
PDS Biotechnology journal publication
NetScientific plc ("NetScientific", AIM:NSCI), the transatlantic
healthcare IP commercialisation group, announces that its portfolio
company PDS Biotechnology Corporation ("PDS") (Nasdaq:PDSB) has
announced a peer-reviewed publication supporting the novel
mechanisms of action of PDS's proprietary Versamune(R) platform in
cancer immunotherapy.
The article "Antigen Priming with Enantiospecific Cationic Lipid
Nanoparticles Induces Potent Antitumor CTL Responses through Novel
Induction of a Type I IFN Response" was published online in the
Journal of Immunology, and describes the way PDS' Versamune(R)
platform recruits and activates killer T-cells to recognize and
effectively attack cancer cells while simultaneously making cancer
cells more susceptible to T-cell attack. The article will appear in
print in the June 2019 issue of the Journal.
NetScientific holds 8.15% of PDS on a fully diluted basis.
The full text of the announcement released by PDS Biotechnology
Corporation can be found below.
# # #
For more information, please contact:
NetScientific Tel: 020 3514 1800
Ian Postlethwaite, CEO and
CFO
Tel: 020 7220 1666
WH Ireland (NOMAD and Broker)
Chris Fielding / Jessica Cave
PDS Biotechnology Announces Publication Supporting Novel
Mechanisms of Action of its Proprietary Versamune(R) Platform in
Cancer Immunotherapy
PDS Biotechnology Corporation ("PDS Biotechnology") (Nasdaq:
PDSB), a clinical-stage immuno-oncology company pioneering the
development of multifunctional immunotherapeutic products, today
announced a peer-reviewed publication supporting the novel
mechanisms of action of its proprietary Versamune(R) platform in
cancer immunotherapy. The article "Antigen Priming with
Enantiospecific Cationic Lipid Nanoparticles Induces Potent
Antitumor CTL Responses through Novel Induction of a Type I IFN
Response" was published online on May 3, 2019 in the Journal of
Immunology, and describes the way PDS' Versamune(R) platform
recruits and activates killer T-cells to recognize and effectively
attack cancer cells while simultaneously making cancer cells more
susceptible to T-cell attack. The article will appear in print in
the June 2019 issue of the Journal.
Dr. Lauren V. Wood, MD, PDS Biotechnology's Chief Medical
Officer, commented: "As a cancer immunologist who has spent the
last decade performing translational and clinical research in
immuno-oncology at the National Cancer Institute, the versatility
of PDS' Versamune(R) technology, and the strength of this recently
published data, demonstrates Versamune(R)'s potential to provide
significant advancements in the treatment of various cancers and
debilitating diseases. With respect to our lead therapeutic
candidate, PDS0101 (a combination of Versamune(R) nanoparticles
plus proprietary human papillomavirus (HPV)-16 E6 and E7 antigens),
the Journal of Immunology article details Versamune(R)'s ability to
overcome the critical mechanisms associated with ineffective immune
responses mediated by HPV16 and cancer cells, therefore leading to
a superior anti-tumor effect. PDS is seeking to confirm this
activity in upcoming clinical studies of PDS0101, which we plan to
initiate by the end of this year. These studies include; a planned
phase 2 combination study to evaluate PDS0101 in combination with
Keytruda(R) in the treatment of head and neck cancer, a phase 2
study to evaluate PDS0101 in advanced HPV-associated cancers, and
an anticipated registration trial to evaluate PDS0101 monotherapy
in the treatment of high-grade cervical dysplasia".
The preclinical study detailed in the Journal of Immunology
article examined the immunological activity of lipids, including
the novel and proprietary cationic lipid enantiomer
R-1,2-dioleoyl-3-trimethyl-ammonium-propane (R-DOTAP, a component
of Versamune(R) nanoparticles). The study was independently
performed at the University of Kentucky School of Medicine in the
laboratory of Professor Jerold Woodward and sponsored by PDS.
Professor Woodward's study corroborated the results of multiple
earlier related preclinical studies, including those by Professor
Leaf Huang, at UNC Chapel Hill and Dr. Samir Khleif at the National
Cancer Institute (U.S. Patent No. 10,286,064).
These preclinical studies confirm the ability of the
Versamune(R) nanotechnology to promote antigen presentation via
both the MHC Class I and Class II pathways, while simultaneously
stimulating production of type 1 interferons. Together, both
mechanisms appear to promote a powerful antigen-specific and
multi-cytokine inducing (polyfunctional) killer T-cell (CD8+)
response with strong potential for superior anti-tumor efficacy. In
a tumor regression study performed with the HPV-tumor model system
(TC-1), a single subcutaneous injection of tumor-bearing mice with
a PDS0101 prototype uniquely induced complete regression of
established tumors, and was associated with a dramatic increase in
the ratio of HPV-specific killer T cells to immune suppressive
regulatory T-cells within the tumor microenvironment prior to
regression.
About the Versamune(R) Cationic Lipid Platform Technology
Versamune(R) is a proprietary, clinical stage, synthetic
lipid-based immunotherapy platform. PDS Biotechnology's pipeline of
Versamune(R)-based products, which are administered by subcutaneous
injection, provides strong activation of type I interferon genes.
The Versamune(R) mechanism of action also involves effective
presentation of tumor antigens via the MHC Class I and Class II
pathways. These two mechanisms together promote strong in-vivo
induction of polyfunctional tumor-targeting CD8+ T-cells as well as
antigen-specific CD4+ T cells. This result, as well as a high
degree of safety, was confirmed in the PDS0101 monotherapy Phase
1/2a human clinical trial.
Versamune(R)-based immunotherapies have been demonstrated to
alter the tumor micro-environment in preclinical mechanism of
action studies, thus further enhancing the ability of
Versamune(R)-induced T-cells to effectively kill tumor cells.
Versamune(R) is now being applied to the development of multiple
clinical-stage cancer products, including those intended to address
both early and late-stage cancer indications as monotherapies, as
well as in combinations with other successful immuno-oncology
approaches such as checkpoint inhibitors.
About PDS Biotechnology
PDS Biotechnology is a clinical stage immuno-oncology company
with a growing pipeline of clinical-stage immunotherapies to treat
various early-stage and late-stage cancers, including head and neck
cancer, cervical, anal, prostate, breast and other cancers.
PDS Biotechnology's lead product candidate, PDS0101
(Versamune(R)-HPV) is a proprietary clinical stage
immunotherapeutic administered by subcutaneous injection being
developed to treat HPV-associated cancers such as head and neck
cancers and anal cancers, both of which are widely reported to be
increasing in frequency over the last decade, as well as cervical,
penile, vaginal and vulvar cancers and their pre-cancerous
conditions. In a human Phase 1/2a clinical study, PDS0101
monotherapy demonstrated potent in-vivo induction of the critical
phenotype of tumor-attacking killer (CD8) T-cells, and induction of
memory T-cells. No dose-limiting toxicities were observed in this
study, suggesting potential for a rare combination of potency and
safety among immune-oncology therapeutics.
For additional information about PDS, please visit
www.pdsbiotech.com.
Forward Looking Statements
This communication contains forward-looking statements
(including within the meaning of Section 21E of the United States
Securities Exchange Act of 1934, as amended, and Section 27A of the
United States Securities Act of 1933, as amended) concerning PDS
Biotechnology Corporation (the "Company") and other matters. These
statements may discuss goals, intentions and expectations as to
future plans, trends, events, results of operations or financial
condition, or otherwise, based on current beliefs of the Company's
management, as well as assumptions made by, and information
currently available to, management. Forward-looking statements
generally include statements that are predictive in nature and
depend upon or refer to future events or conditions, and include
words such as "may," "will," "should," "would," "expect,"
"anticipate," "plan," "likely," "believe," "estimate," "project,"
"intend," and other similar expressions among others. Statements
that are not historical facts are forward-looking statements.
Forward-looking statements are based on current beliefs and
assumptions that are subject to risks and uncertainties and are not
guarantees of future performance. Actual results could differ
materially from those contained in any forward-looking statement as
a result of various factors, including, without limitation: the
ability of the Company to integrate Edge and PDS Biotechnology
following the merger; the Company's ability to protect its
intellectual property rights; competitive responses to the
completion of the merger; potential adverse reactions or changes to
business relationships resulting from the completion of the merger;
the Company's ability to access capital markets, the timing for the
Company to initiate two clinical trials for its lead asset,
PDS0101; the successful implementation of the Company's research
and development programs and collaborations; the acceptance by the
market of the Company's product candidates, if approved; and other
factors, including legislative, regulatory, political and economic
developments not within the Company's control. The foregoing review
of important factors that could cause actual events to differ from
expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and
elsewhere, including the risk factors included in the Company's
annual and periodic
reports filed with the SEC. The forward-looking statements are
made only as of the date of this press release and, except as
required by applicable law, the Company undertakes no obligation to
revise or update any forward-looking statement, or to make any
other forward-looking statements, whether as a result of new
information, future events or otherwise.
This information is provided by RNS, the news service of the
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contact rns@lseg.com or visit www.rns.com.
END
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