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® 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® 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® technology, and the strength of this
recently published data, demonstrates Versamune®’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®
nanoparticles plus proprietary human papillomavirus (HPV)-16 E6 and
E7 antigens), the Journal of Immunology article details
Versamune®’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® 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® 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® 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® Cationic Lipid
Platform TechnologyVersamune® is a proprietary, clinical
stage, synthetic lipid-based immunotherapy platform. PDS
Biotechnology’s pipeline of Versamune®-based products, which are
administered by subcutaneous injection, provides strong activation
of type I interferon genes. The Versamune® 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®-based immunotherapies have been
demonstrated to alter the tumor micro-environment in preclinical
mechanism of action studies, thus further enhancing the ability of
Versamune®-induced T-cells to effectively kill tumor cells.
Versamune® 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 BiotechnologyPDS
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®-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 StatementsThis
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.
Media & Investor Relations
Contact:Tram Bui / Alexander LoboThe Ruth GroupPhone:
+1-646-536-7035 / +1-646-536-7037Email: tbui@theruthgroup.com /
alobo@theruthgroup.com
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