PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing a novel therapy for HPV-associated
cancer based on the Company’s proprietary Versamune® T-cell
activating technology, and the Head and Neck Cancer Alliance (HNCA)
today announced a partnership. This collaboration seeks to raise
awareness of new and developing treatment options, including
available clinical trials, for patients with HPV-attributed head
and neck cancer diagnoses.
Unlike many other cancers, the incidence of head and neck cancer
is increasing in the United States, primarily due to rates of
infection with human papillomavirus (HPV). Because head and neck
cancer is often diagnosed at later stages, treatment is often more
difficult and more invasive. PDS Biotech is working to change the
landscape of HPV-attributed head and neck cancer treatment with
their lead candidate, PDS0101, which uses Versamune® to activate
the immune system to recognize HPV-associated cancer cells and
respond by inducing T-cells to attack and destroy them.
Partnerships such as the one between PDS Biotech and HNCA are
becoming more common in the patient advocacy and biotechnology
spaces. By combining their efforts, partners can more efficiently
spread the word about emerging treatments, clinical trials, and
additional options for patients who may not have responded to
traditional therapies.
“Raising awareness of treatment options for patients and their
families who are dealing with head and neck cancer that has
returned or spread is critical,” said Dr. Lauren V. Wood, Chief
Medical Officer of PDS Biotech. “Treatment options for these
patients can be limited and the search often expands to include
investigational therapies being studied in clinical research. We’re
excited to partner with the HNCA to raise awareness of these
options for patients and physicians.”
“There are exciting things happening in clinical research for
head and neck cancer therapies,” said Amanda Hollinger, Executive
Director of HNCA. “Partnering with companies like PDS Biotech who
are leading the way forward and working together to raise awareness
of new and developing treatment options brings hope to patients,
survivors, and families of those battling cancer, as well as
offering new avenues of treatment for clinicians.”
Head and neck cancer refers to cancers that arise in the mouth,
voice box, throat, sinuses, nasal cavity, or salivary glands.
Worldwide in 2021, there will be more than 650,000 new cases of
oral, head and neck cancer diagnosed and approximately 330,000
deaths from these cancers. Over the last few decades, there has
been a 225% increase in HPV-attributed head and neck cancer
diagnoses. In 2018, head and neck cancer surpassed cervical cancer
as the most common HPV-attributed cancer in the United States.
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.
About Head and Neck Cancer AllianceHNCA’s
mission is to advance prevention, detection, treatment and
rehabilitation of oral, head and neck cancer through public
awareness, research, advocacy and survivorship. As the one-stop
center for patients, survivors, and family members seeking
information about head and neck cancer, HNCA provides support to
head and neck cancer patients throughout the year and works in
partnership with healthcare, corporate, and community partners to
raise awareness of ongoing research in head and neck oncology and
educate the public in the disease process, treatment and prevention
of oral, head and neck cancers. Led by a Board of Directors with
expertise in head and neck surgery, research, and survivorship,
HNCA develops strategic priorities to tackle the challenges facing
those impacted by this disease.
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.
PDS Biotech 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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