PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing a growing pipeline of targeted
cancer immunotherapies and infectious disease vaccines based on the
Company’s proprietary T cell activating platforms, today
announced that an abstract detailing immune response data from
the VERSATILE-002 Phase 2 clinical trial investigating PDS0101 in
combination with Merck’s anti-PD-1 therapy, KEYTRUDA®
(pembrolizumab), in patients with unresectable, recurrent or
metastatic human papillomavirus (HPV)16-positive head and neck
cancer has been accepted for presentation at the European Society
for Medical Oncology Congress 2023 (ESMO Congress 2023). ESMO
Congress 2023 is being held October 20-24, 2023 in Madrid.
The abstract, titled, “Polyfunctional
HPV16-Specific T cell responses in subjects receiving PDS0101 and
pembrolizumab combination treatment for recurrent/metastatic
HPV16-positive head and neck squamous cell carcinoma (HNSCC),”
reports on the ability of PDS0101 in combination with KEYTRUDA® to
induce the right type of HPV16-specific multifunctional T cell
responses in the treatment of advanced HPV16-positive head and neck
cancer. PDS0101 is designed to stimulate a potent targeted T cell
attack against HPV16-positive cancers. The immunological clinical
data demonstrates the immunotherapy’s potential to generate
clinically-relevant multifunctional HPV16-targeted CD8 and CD4 T
cells with minimal toxicity in advanced head and neck cancer
patients.
“We are pleased to present biomarker data from
the VERSATILE-002 clinical trial among a gathering of the world’s
leading members of the clinical and scientific oncology community
at ESMO Congress 2023,” stated Lauren V. Wood, M.D., PDS Biotech’s
Chief Medical Officer and a co-author of the study. “The incidence
of HPV-positive head and neck cancers is growing rapidly, and there
is currently a lack of effective targeted therapies to address this
population. To date, multiple studies in early-stage and advanced
cancer patients have demonstrated the ability of PDS0101 to induce
high levels of active and potent HPV16-specific CD4 and CD8
multifunctional T cells, as well as long-lasting memory CD8 T
cells, substantiating the potential for PDS0101 combined with
KEYTRUDA® to expand the range of treatments addressing
HPV16-positive head and neck cancers.”
Abstract Title: Polyfunctional
HPV16-Specific T cell responses in subjects receiving PDS0101 and
pembrolizumab combination treatment for recurrent/metastatic
HPV16-positive head and neck squamous cell carcinoma
(HNSCC)Abstract Number: 6982Presenting
Author: Dr. Kevin Harrington, Ph.D., Professor of
Biological Cancer Therapies, The Royal
MarsdenAuthors: K. Harrington, J. Weiss, K. Price,
J. Kaczmar, D. Schaaf, N. Riebel, S. Jones, A. Cotty, S. McCarthy,
L. Wood
For patients interested in enrolling in this clinical trial,
please contact NCI’s toll-free number 1-800-4-Cancer
(1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web
site: https://trials.cancer.gov and/or NCIMO_referrals@mail.nih.gov.
About PDS0101PDS0101, PDS
Biotech’s lead candidate, is a novel investigational human
papillomavirus (HPV)-targeted immunotherapy that stimulates a
potent targeted T cell attack against HPV-positive cancers. PDS0101
is given by subcutaneous injection alone or in combination with
other immunotherapies and cancer treatments. In a Phase 1 study of
PDS0101 in monotherapy, the treatment demonstrated the ability to
generate multifunctional HPV16-targeted CD8 and CD4 T cells with
minimal toxicity. Interim data suggests PDS0101 generates
clinically effective immune responses and the combination of
PDS0101with other treatments can demonstrate significant disease
control by reducing or shrinking tumors, delaying disease
progression, and/or prolonging survival. The combination of PDS0101
with other treatments does not appear to compound the toxicity of
other agents.
About
VERSATILE-002 VERSATILE-002 is a single-arm Phase 2
trial evaluating the safety and efficacy of PDS0101, an
HPV16-targeted investigational T cell-activating immunotherapy that
leverages PDS Biotech’s proprietary Versamune® technology, in
combination with Merck’s anti-PD-1 therapy, KEYTRUDA®
(pembrolizumab). The combination is being evaluated in immune
checkpoint inhibitor (ICI)-naïve and ICI-refractory patients with
recurrent/metastatic HPV16-positive head and neck squamous cell
carcinoma (HNSCC) and was granted Fast Track designation by the
Food and Drug Administration in June 2022.
Interim efficacy and safety data were presented
at the 2023 American Society of Clinical Oncology (ASCO) Annual
Meeting for ICI-naïve patients. Preliminary data from the first 34
patients demonstrated a 12-month overall survival rate of 87% and
median progression free survival of 10.4 months. No Grade 4 or
higher treatment related adverse events were observed.
KEYTRUDA® is a registered trademark of Merck
Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc.,Rahway,
NJ, USA.
About PDS BiotechnologyPDS
Biotech is a clinical-stage immunotherapy company developing a
growing pipeline of targeted cancer and infectious disease
immunotherapies based on our proprietary Versamune®, Versamune®
plus PDS0301, and Infectimune™ T cell-activating platforms. We
believe our targeted immunotherapies have the potential to overcome
the limitations of current immunotherapy approaches through the
activation of the right type, quantity and potency of T cells. To
date, our lead Versamune® clinical candidate, PDS0101, has
demonstrated the ability to reduce and shrink tumors and stabilize
disease in combination with approved and investigational
therapeutics in patients with a broad range of HPV16-associated
cancers in multiple Phase 2 clinical trials and will be advancing
into a Phase 3 clinical trial in combination with KEYTRUDA® for the
treatment of recurrent/metastatic HPV16-positive head and neck
cancer in 2023. Our Infectimune™ based vaccines have also
demonstrated the potential to induce not only robust and durable
neutralizing antibody responses, but also powerful T cell
responses, including long-lasting memory T cell responses in
pre-clinical studies to date. To learn more, please visit
www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
Forward Looking StatementsThis
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® and Infectimune™ based product candidates; 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® and Infectimune™ based product candidates 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 the Company’s ability to fully fund its disclosed
clinical trials, which assumes no material changes to the Company’s
currently projected expenses), futility analyses, presentations at
conferences and data reported in an abstract, and receipt of
interim or preliminary results (including, without limitation, any
preclinical results or data), 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; and other factors, including legislative,
regulatory, political and economic developments not within the
Company’s control. 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
other risks, uncertainties, and other factors described under “Risk
Factors,” “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and elsewhere in the documents
we file with the U.S. Securities and Exchange Commission. 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.
Versamune® is a registered trademark and
Infectimune™ is a trademark of PDS Biotechnology. KEYTRUDA® is a
registered trademark of Merck Sharp and Dohme LLC, a subsidiary of
Merck & Co., Inc.,Rahway, N.J., USA.
Investor Contacts:Deanne
RandolphPDS BiotechPhone: +1 (908) 517-3613Email:
drandolph@pdsbiotech.com
Rich CockrellCG CapitalPhone: +1 (404)
736-3838Email: pdsb@cg.capital
Media Contacts:Tiberend
Strategic Advisors, Inc.Dave SchemeliaPhone: +1 (609)
468-9325dschemelia@tiberend.com
Eric ReissPhone: +1 (802)
249-1136ereiss@tiberend.com
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