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PDS Biotech Initiates VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Recurrent/Metastatic Head and Neck Cancer in Collaboration with Merck

Mon 9th November, 2020 9:05pm
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FLORHAM PARK, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- PDS Biotechnology
Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology company
developing novel cancer therapies and infectious disease vaccines based on the
Company’s proprietary Versamune(®) T-cell activating technology, today
announced that its VERSATILE-002 Phase 2 clinical trial evaluating the
combination of PDS0101 and KEYTRUDA(®) (pembrolizumab) for the first-line
treatment of head and neck cancer that has returned or spread is now open. The
trial is being conducted in collaboration with Merck.

The VERSATILE-002 Phase 2 trial is a multi-center, open label, single arm,
non-randomized trial that plans to enroll approximately 100 patients across 25
sites in the U.S. The University of Tennessee Medical Center is the first site
to open. The studies to be performed at the UT Medical Center will be led by
Principal Investigator Dr. Timothy Panella, M.D. The clinical study will
evaluate the efficacy and safety of PDS0101, PDS Biotech’s lead
Versamune(®)-based immunotherapy targeting human papillomavirus
(HPV)-associated cancers, in combination with KEYTRUDA(®) (pembrolizumab),
Merck's checkpoint inhibitor, in the first-line treatment of patients with
HPV16-positive head and neck cancer that has returned or spread. KEYTRUDA(®)
was approved by the FDA in June 2019 as first-line treatment for recurrent or
metastatic head and neck cancer. VERSATILE-002 will study if combining PDS0101
with KEYTRUDA(®) is more effective than what has been previously shown with
KEYTRUDA(®) alone. The main efficacy endpoint in this study is shrinkage of
the tumor referred to as the objective response rate (ORR) at nine months
following the initiation of treatment with the combination.

“The launch of the VERSATILE-002 Phase 2 trial demonstrates our commitment
to developing a safe and effective treatment option that builds upon the
current standard of care for patients with this aggressive cancer and further
strengthens our collaboration with Merck,” commented Dr. Frank Bedu-Addo,
CEO of PDS Biotech. “Though the COVID-19 pandemic impacted our initial
timeline, we are pleased to open up this trial to patients.”

Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech added, “Initial
studies suggest that Versamune(®)-based immunotherapies administered in
combination with checkpoint inhibitors, such as KEYTRUDA(®), have the
potential to enhance the immune system’s ability to induce a more powerful
and targeted anti-tumor response. We look forward to sharing updates as this
study progresses.”

“We are thrilled to offer our patients with recurrent or metastatic head and
neck cancer such an exciting and potentially safe treatment option,”
commented Dr. Timothy Panella, who is the VERSATILE-002 Principal Investigator
at the UT Medical Center, “this type of combination approach is attractive
to patients and offers a novel targeted therapy in the fight against this very
challenging disease.”

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the
University of Carolina at Chapel Hill School of Medicine and Lineberger
Comprehensive Cancer Center, is serving as the Lead Principal Investigator of
VERSATILE-002. Patients interested in enrolling in this clinical study should
email info@pdsbiotech.com or visit the website at
http://pdsbiotech.com/VERSATILE-002 to learn more.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline
of cancer immunotherapies and infectious disease vaccines based on the
Company’s proprietary Versamune(®) T-cell activating technology platform.
Versamune(®) effectively delivers disease-specific antigens for in vivo
uptake and processing, while also activating the critical type 1 interferon
immunological pathway, resulting in production of potent disease-specific
killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered
multiple therapies, based on combinations of Versamune(®) and
disease-specific antigens, designed to train the immune system to better
recognize disease cells and effectively attack and destroy them. 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(®) platform with targeted antigens in HPV-expressing cancers. In
partnership with Merck and Co., PDS Biotech is advancing a combination of
PDS0101 and KEYTRUDA(®) to a Phase 2 study in first-line treatment of
recurrent or metastatic head and neck cancer. In separate partnership with the
National Cancer Institute (NCI), and The University of Texas MD Anderson
Cancer Center, PDS Biotech is conducting additional Phase 2 studies in
advanced HPV-associated cancers and advanced localized cervical cancer

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,”
“forecast,” “guidance,” “outlook” and other similar expressions
among others. 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 Company’s ability to protect its
intellectual property rights; the Company’s anticipated capital
requirements, including the Company’s anticipated cash runway and the
Company’s current expectations regarding its plans for future equity
financings; the Company’s dependence on additional financing to fund its
operations and complete the development and commercialization of its product
candidates, and the risks that raising such additional capital may restrict
the Company’s operations or require the Company to relinquish rights to the
Company’s technologies or product candidates; the Company’s limited
operating history in the Company’s current line of business, which makes it
difficult to evaluate the Company’s prospects, the Company’s business plan
or the likelihood of the Company’s successful implementation of such
business plan; the timing for the Company or its partners to initiate the
planned clinical trials for its lead asset, PDS0101; the future success of
such trials; the successful implementation of the Company’s research and
development programs and collaborations, including any collaboration studies
concerning PDS0101 and the Company’s interpretation of the results and
findings of such programs and collaborations and whether such results are
sufficient to support the future success of the Company’s product
candidates; the acceptance by the market of the Company’s product
candidates, if approved; the timing of and the Company’s ability to obtain
and maintain U.S. Food and Drug Administration or other regulatory authority
approval of, or other action with respect to, the Company’s product
candidates; and other factors, including legislative, regulatory, political
and economic developments not within the Company’s control, including
unforeseen circumstances or other disruptions to normal business operations
arising from or related to COVID-19. 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:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Jacob Goldberger
CG Capital 
Phone: +1 (404) 736-3841 
Email: jacob@cg.capital



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