PDS Biotech Granted Patent for its Novel HPV16 Immunotherapy
January 10 2022 - 7:00AM
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 it has been granted U.S. Patent Application
No. 15,724,818 titled “Novel HPV16 Non HLA-Restricted T-cell
Vaccines, Composition and Methods of Use Thereof” by the United
States Patent and Trademark Office (USPTO).
The newly issued patent covers the PDS0101
immunotherapy which consists of a combination of the Versamune
technology platform with a unique mixture of short protein
fragments derived from the cancer-causing virus, HPV16. The
composition promotes the induction of killer (CD8+) T-cells by the
immune system that recognize, and attack cancers caused by
infection with HPV16 irrespective of the patients’ genetic
makeup.
HPV16 is the most oncogenic or cancer-causing
type of HPV, and is by far the most prevalent in patients with
advanced HPV-associated cancers, including anal, cervical, head and
neck, penile, vaginal and vulvar cancers. More than 40,500
patients are diagnosed with HPV16-associated cancers each year
according to the International Journal of Cancer. Some of
these cancers have been reported to be increasing in incidence over
the last few years.
“We remain excited about the promising early
efficacy and safety data from our ongoing Phase 2 clinical
trials. The early clinical data coupled with the recent grant
of the PDS0101 patent that runs into late 2037 puts PDS Biotech in
a strong position to progress commercialization of the product to
address a significant unmet need for more effective treatment of
advanced HPV-associated cancers,” stated Frank Bedu-Addo, Chief
Executive Officer of PDS Biotech.
In partnership with Merck & Co., PDS Biotech
is evaluating a combination of PDS0101 and KEYTRUDA® in a
Phase 2 study (NCT04260126) in first-line treatment of recurrent or
metastatic head and neck cancer, and also in second-line treatment
of recurrent or metastatic head and neck cancer in patients who
have failed prior checkpoint inhibitor therapy. 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.
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) 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 Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital
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