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PDS Biotech Achieves Safety Requirement Milestone For the First 12 Patients in the VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Advanced Head and Neck Cancer

Mon 20th September, 2021 1:30pm
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FLORHAM PARK, N.J., Sept. 20, 2021 (GLOBE NEWSWIRE) -- 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 its VERSATILE-002 Phase 2 study
for the treatment of advanced human papillomavirus (HPV16)-associated head and
neck cancer achieved its preliminary safety benchmark in its first 12
patients. Enrollment in the trial, which studies PDS0101 administered in
combination with KEYTRUDA(®) (pembrolizumab), will now continue to full
enrollment of the first stage of the study, which will assess efficacy in 17
checkpoint inhibitor (CPI) naïve patients and in an additional group of 21
patients who have also failed prior therapy with checkpoint inhibitors (CPI
refractory). The trial is being conducted in collaboration with Merck & Co.

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 CPI therapy (CPI
refractory). As specified in the clinical trial design, the achievement of an
objective response as measured by radiographic tumor responses according to
RECIST 1.1 (tumor reduction of 30% or more) among at least four of the first
17 patients in the CPI naïve arm and at least 2 patients in the first 21
patients of the CPI refractory arm will trigger advancement to the second
stage of the study and full enrollment of the planned 95 patients.

“The achievement of this important milestone in the VERSATILE-002 Phase 2
clinical trial strengthens the evidence regarding the safety of PDS0101.
Treatment-related adverse events (TRAEs) generally appear to be limited to
transient, manageable local injection site reactions,” commented Dr. Lauren
V. Wood, Chief Medical Officer of PDS Biotech. “There is an enormous unmet
medical need for more effective treatment of advanced head and neck cancer. We
believe the combination of PDS0101 and KEYTRUDA(®) has the potential to
significantly improve clinical outcomes for these patients who have limited
treatment options. We look forward to continuing to share data from this trial
as they become available.”

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.

The advancement of the VERSATILE-002 trial follows the previously disclosed
presentation at the American Society of Clinical Oncology (ASCO) 2021 Annual
Meeting of interim data in a separate Phase 2 trial (NCT04287868) being led by
the National Cancer Institute (NCI). That trial is evaluating the combination
of PDS0101 with two investigational immunotherapies in patients with advanced
HPV-related cancers. That trial has enrolled patients with anal, cervical,
head and neck, vaginal and vulvar cancer, who have failed prior treatment.
Objective responses measured according to RECIST 1.1 (tumor reduction of 30%
or more) were reported in 83% (5/6) of HPV16-positive patients who had failed
chemotherapy and radiation but were CPI naive. In CPI refractory patients,
tumor reduction was reported in 58% (7/12) and objective responses in 42%
(5/12). Two patients, one in each group were reported to have a complete
response (no evidence of disease) at the time of reporting. Clinical responses
were observed in all HPV16-positive tumor types enrolled. More information on
this study can be found on PDS Biotech’s website.

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

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838 
Email: rich@cg.capital


GlobeNewswire, Inc. 2021
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