PDS Biotech Announces Presentation of PDS0101 Data at the 2022 Multidisciplinary Head and Neck Cancers Symposium
January 12 2022 - 08:00AM
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 that the initial safety data from its VERSATILE-002
study has been accepted for presentation at the 2022
Multidisciplinary Head and Neck Cancers Symposium being held
February 24-26, 2022, at the JW Marriott Phoenix Desert Ridge
Resort and Spa, Phoenix, AZ.
The accepted abstract summarizes initial safety
data from the ongoing Phase 2 study, being run in collaboration
with Merck (known as MSD outside the US and Canada) (NCT04260126),
which studies PDS0101 in combination with Merck’s anti-PD-1 therapy
KEYTRUDA® (pembrolizumab) for the treatment of recurrent or
metastatic HPV16-positive head and neck cancer. It was previously
announced that the trial had achieved its preliminary safety
benchmark in the first 12 patients.
“We continue to be encouraged by the data and
look forward to the presentation of safety data from this study,”
said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “The
Multidisciplinary Head and Neck Cancers Symposium brings together
experts in head and neck cancers from around the world and we look
forward to sharing this data with this important group of
physicians and scientists.”
Abstract Number: 157Abstract
Title: Preliminary Safety of PDS0101 (Versamune® +HPVmix)
and Pembrolizumab Combination Therapy in Subjects with
Recurrent/Metastatic Human Papillomavirus-16 Positive Oropharyngeal
Squamous Cell Carcinoma (OPSCC)Presenter: Jared
Weiss, M.D., Associate Professor of Medicine, Division of Oncology
at UNC School of Medicine, UNC Lineberger Comprehensive Cancer
Center
PDS Biotech is also conducting a Phase 2
clinical study in both second- and third-line treatment of multiple
advanced HPV-associated cancers with the National Cancer Institute
(NCI). A third Phase 2 clinical trial in first-line treatment of
locally advanced cervical cancer is being performed with The
University of Texas, MD Anderson Cancer Center (IMMUNOCERV).
KEYTRUDA® is a registered trademark of Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Kenilworth, NJ, USA.
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
HPV16-associated cancers (anal, cervical, head and neck, penile,
vaginal, vulvar) and breast, colon, lung, prostate and ovarian
cancers. To learn more, please visit www.pdsbiotech.com or
follow us on Twitter at @PDSBiotech.
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.
Investor Contact:
Rich CockrellCG CapitalPhone: +1 (404)
736-3838pdsb@cg.capital
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