PDS Biotechnology Expands VERSATILE-002 study of PDS0101 and KEYTRUDA® in Advanced Head and Neck Cancer to Include Patients ...
June 03 2021 - 8:53AM
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing novel cancer therapies and
infectious disease vaccines based on the Company’s proprietary
Versamune® T-cell activating technology, today announced the
protocol amendment to expand its Phase 2 VERSATILE-002 study to
include patients, in an additional arm, who have failed prior
checkpoint inhibitor (CPI) therapy (CPI refractory patients). The
VERSATILE-002 study is designed to evaluate PDS0101 in combination
with KEYTRUDA® (pembrolizumab) in the treatment of advanced human
papillomavirus (HPV)-associated head and neck cancer and is
currently being run at approximately 20 clinical sites in the US.
VERSATILE-002 was initially opened to checkpoint
inhibitor naive HPV16-associated head and neck cancer patients in
first line treatment of recurrent or metastatic cancer.
The trial is actively recruiting patients who have the option to
receive the two immunotherapies rather than chemotherapy as their
first line of treatment for recurrent disease. The additional study
arm will evaluate the objective response to the combination among
approximately 40 patients with advanced head and neck cancer who
have failed multiple treatments, including checkpoint inhibitor
therapy. Objective response is measured by radiographic tumor
responses according to RECIST 1.1. In the expansion arm, the first
21 patients will be evaluated for safety and objective response
before the arm progresses to full enrollment.
The inclusion of CPI refractory patients in
VERSATILE-002 follows the publication of an abstract and subsequent
presentation of interim data in another Phase 2 trial (NCT04287868)
being led by the National Cancer Institute (NCI) evaluating the
combination of PDS0101 (Versamune®-HPV16) in combination with two
investigational immunotherapies. That trial recently reported
clinical responses with objective responses (tumor reduction of 30%
or more) in 63% (5/8) of HPV16-positive cancer patients who had
failed chemotherapy, radiation, and checkpoint inhibitor
therapy.
“There is an enormous unmet medical need in
advanced head and neck cancer patients who have failed multiple
therapies, including chemotherapy, radiation and checkpoint
inhibitor therapy. We believe the combination of PDS0101 and
KEYTRUDA® has the potential to significantly improve clinical
outcomes for these patients who have limited treatment options,”
commented Dr. Lauren Wood, Chief Medical Officer of PDS
Biotech.
Dr. Jared Weiss, Associate Professor of
Medicine, Division of Oncology, University of North Carolina at
Chapel Hill School of Medicine and Lineberger Comprehensive Cancer
Center, is serving as the Principal Investigator of this Phase 2
clinical trial in advanced HPV16-associated head and neck cancer.
For patients interested in learnings more about this clinical
study, please visit the website:
https://pdsbiotech.com/versatile-002.
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® T-cell activating technology platform. Our
Versamune®-based products 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
therapies, based on combinations of Versamune® 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® platform with targeted antigens in
HPV-expressing cancers. In partnership with Merck and Co.,
PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® 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.
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 PDS0101, PDS0203 and other Versamune® based
products; 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, PDS0203 and other Versamune® based products 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 success, timing and cost of the Company’s ongoing clinical
trials and anticipated clinical trials for the Company’s current
product candidates, including statements regarding the timing of
initiation, pace of enrollment and completion of the trials
(including our ability to fully fund our disclosed clinical trials,
which assumes no material changes to our currently projected
expenses), futility analyses, presentations at conferences and data
reported in an abstract, and receipt of interim results, which are
not necessarily indicative of the final results of the Company’s
ongoing clinical trials; any Company statements about its
understanding of product candidates mechanisms of action and
interpretation of preclinical and early clinical results from its
clinical development programs and any collaboration studies; 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 RandolphPDS BiotechPhone: +1 (908)
517-3613Email: drandolph@pdsbiotech.com
Rich CockrellCG CapitalPhone: +1 (404) 736-3838
Email: rich@cg.capital
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