PDS Biotech to Host Key Opinion Leader Roundtable Addressing Current and Future Treatments for Recurrent/Metastatic HPV-Positive HNSCC and the Potential Application of PDS0101 on September 27, 2023
13 9월 2023 - 9:00PM
PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or
Company), 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 it will host a Key
Opinion Leader (KOL) Roundtable on Addressing Current and Future
Treatments for Recurrent/Metastatic Human Papillomavirus
(HPV)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC) and
the Potential Application of PDS0101, including an update from the
Phase 2 VERSATILE-002 trial, for analysts, investors and the
scientific community from 8:00 – 9:00 AM EDT on Wednesday,
September 27, 2023.
The Company-sponsored event will focus on
current and potential treatments for HPV16-positive head and neck
cancer, including the emerging use of circulating tumor DNA
(ctDNA), and unmet needs of this growing patient population. The
event will also include a presentation on updated data from the
VERSATILE-002 study of the combination of KEYTRUDA® (pembrolizumab)
and PDS0101, PDS Biotech’s novel investigational HPV-targeted
immunotherapy, as well as the design for the planned VERSATILE-003
Phase 3 clinical trial due to be initiated in the fourth quarter of
2023. The event will be moderated by PDS Biotech’s Chief Medical
Officer, Dr. Lauren V. Wood, and will feature presentations from
the following head and neck cancer KOLs:
- Dr. Glenn Hanna, Assistant
Professor, Harvard University and Medical Oncologist, Dana-Farber
Cancer Institute
- Dr. John Kaczmar, Associate
Professor, Medical University of South Carolina
- Dr. Ricard Mesía, Head of Medical
Oncology, Catalan Institute of Oncology
- Dr. Katharine Price, Associate
Professor, Oncology Head and Neck Disease Group, Mayo Clinic
Comprehensive Cancer Center
Registration of PDS Biotech’s KOL Roundtable is
now open, and a live webcast of the event will be available online
in the investor relations section of the Company’s website at
https://www.pdsbiotech.com/index.php/investors. A replay will be
available for 90 days following the webcast.
About PDS Biotechnology
PDS 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.
About PDS0101
PDS0101, 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 active immune responses,
and the combination of PDS0101 with 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-003
VERSATILE-003 is a randomized, controlled Phase 3 trial
evaluating the safety and efficacy of PDS0101 in combination with
Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) compared with
KEYTRUDA® monotherapy as the control arm. The primary end point for
the study is patient overall survival (OS). The combination is
being evaluated in immune checkpoint inhibitor (ICI)-naïve 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.
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® 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® and Infectimune® are registered trademarks of PDS
Biotechnology Corporation. KEYTRUDA® is a registered trademark of
Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, N.J., USA.
Investor Contact:Rich
CockrellCG CapitalPhone: +1 (404) 736-3838Email:
pdsb@cg.capitalMedia Contacts:Dave
SchemeliaTiberend Strategic AdvisorsPhone: +1 (609) 468-9325Email:
dschemelia@tiberend.com
Eric ReissTiberend Strategic AdvisorsPhone: +1
(802) 249-1136Email: ereiss@tiberend.com
PDS Biotechnology (NASDAQ:PDSB)
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