PDS Biotech Enrolls First Stage of Checkpoint Inhibitor Naïve Patient Arm of Phase 2 Clinical Trial in Advanced HPV-16 Positive Head and Neck Cancer
October 04 2021 - 8:30AM
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing novel cancer therapies based on
the Company’s proprietary Versamune® T-cell activating technology,
today announced the completion of enrollment for the first stage of
the checkpoint inhibitor naïve arm of its VERSATILE-002 Phase 2
study for the treatment of recurrent and/or metastatic human
papillomavirus (HPV16)-associated head and neck cancer. 90% of
HPV-associated head and neck cancers are reported to be caused by
HPV16 as reported by a study published in the Journal of Clinical
Medicine.
VERSATILE-002 is studying two groups of
HPV16-positive head and neck cancer patients whose cancer has
returned or spread. The first group has not been previously treated
with a checkpoint inhibitor (CPI naïve). The second group of
patients have failed multiple treatments including checkpoint
inhibitor therapy (CPI refractory). As specified in the clinical
trial design, objective response is measured by radiographic tumor
responses according to RECIST 1.1 (tumor reduction of 30% or more).
If objective response is achieved among at least four of the first
17 patients in the CPI naïve arm, this will trigger advancement to
the second stage of the study arm and enrollment of the planned 54
patients in the CPI naïve arm. The trial is being conducted in
collaboration with Merck & Co.
“Completion of enrollment among checkpoint
inhibitor naïve patients in this first stage of our VERSATILE-002
Phase 2 study in the CPI naïve arm is an important milestone, and
we would like to thank the patients for their participation in this
clinical trial,” said Dr. Lauren V. Wood, Chief Medical Officer of
PDS Biotech. “Through their involvement, together with site
Investigators and study staff, this trial will help us better
understand the potential contribution that PDS0101 may have in
improving the lives of patients with advanced head and neck
cancer.”
Dr. Jared Weiss, Section Chief of Thoracic and
Head and Neck Oncology at the University of North 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 developing a growing pipeline of cancer immunotherapies
based on the Company’s proprietary Versamune® T-cell activating
technology platform. Our Versamune®-based products have
demonstrated the potential to 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. The
company’s pipeline products address various cancers including
breast, colon, lung, prostate and ovarian 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 & 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 or monitoring committees’ or other third parties’
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, significance of milestones, 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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