PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the
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 that data from the IMMUNOCERV
Phase 2 clinical trial investigating PDS0101 in combination with
standard-of-care chemoradiotherapy (CRT) for the treatment of
locally advanced cervical cancer will be featured in an oral
presentation at the American Society for Radiation Oncology (ASTRO
2023) Annual Meeting. ASTRO 2023 is being held October 1-4, 2023,
in San Diego, CA.
The abstract, titled “HPV Circulating Cell-Free
DNA Kinetics in Cervical Cancer Patients Undergoing Definitive
Chemoradiation,” will report on the levels of circulating
HPV-positive cell-free DNA (HPV-cfDNA) in the blood of 47 cervical
cancer patients during and after CRT treatment, including subjects
in the IMMUNOCERV study who received PDS0101 in addition to CRT.
The research is designed to evaluate the relationship between the
levels of circulating HPV viral DNA and the extent of disease,
clinical staging, and treatment response in patients with
HPV-positive cervical cancer. The findings will be presented by Dr.
Aaron Seo, MD, Ph.D., The University of Texas MD Anderson Cancer
Center.
“We are pleased that PDS0101 is being evaluated
in this cutting-edge approach to better understand the patients’
prognosis and the mechanism by which PDS0101 may impact clinical
outcomes in cervical cancer, and we look forward to Dr. Seo’s
presentation at ASTRO 2023,” stated Dr. Lauren V. Wood, Chief
Medical Officer of PDS Biotech. “Examination of HPV-cfDNA in this
larger cohort of patients will also provide additional insights to
the IMMUNOCERV data presented at SITC 2022, which suggested that
PDS0101 promotes the induction of multifunctional CD8 killer T
cells that were associated with declines in circulating tumor DNA
and 100% (9/9) clinical response with greater than 60% tumor
shrinkage at mid-point evaluation in high-risk cervical cancer
patients.”
The IMMUNOCERV Phase 2 study is investigating
PDS0101 in combination with standard-of-care CRT in the treatment
of patients with large tumors over 5 cm in size and/or cancer that
has spread to the lymph nodes.Presentation
Details:Abstract
#: 55593 Abstract
Title: HPV Circulating Cell-Free DNA Kinetics in
Cervical Cancer Patients Undergoing Definitive
Chemoradiation Presenter: Aaron
Seo Author Block: Aaron Seo, Weihong
Xiao, Olsi Gjyshi, Kyoko Court, Tatiana Cisneros Napravnik,
Aradhana Venkatesan, Erica Lynn, Julie Sammouri, Lauren Colbert,
Anuja Jhingran, Melissa Joyner, Lilie Lin, Maura Gillison, Ann
Klopp Scientific Session Number: SS
02 Scientific Session Title: GYN
1: Integrating the Next Wave of Biomarkers for Future Gynecologic
Clinical Trials Session
Date/Time: October 1, 8:00AM-9:00AM
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 Versamune®
Versamune® is a novel investigational T cell
activating platform which effectively stimulates a precise immune
system response to a cancer-specific protein. Versamune® based
investigational immunotherapies promote a potent targeted T cell
attack against cancers expressing the protein. They are given by
subcutaneous injection and can be combined with standard of care
treatments. Clinical data suggest that Versamune® based
investigational immunotherapies, such as PDS0101, demonstrate
meaningful disease control by reducing and shrinking tumors,
delaying disease progression and/or prolonging survival. Versamune®
based immunotherapies have demonstrated minimal toxicity to date
that may allow them to be safely combined with other treatments. We
believe Versamune® based investigational immunotherapies represent
a transformative treatment approach for cancer patients to provide
improved efficacy, safety and tolerability.
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 effective 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.
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. KEYTRUDA® is a registered
trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck &
Co., Inc., Rahway, N.J., USA.
Investor Contacts: Deanne
Randolph PDS Biotech Phone: +1 (908) 517-3613 Email:
drandolph@pdsbiotech.com
Rich Cockrell CG Capital Phone: +1
(404) 736-3838 Email: pdsb@cg.capital
Media Contacts: Dave
Schemelia Tiberend Strategic Advisors Phone: +1 (609)
468-9325 Email: dschemelia@tiberend.com
Eric Reiss Tiberend Strategic
Advisors Phone: +1 (802) 249-1136 Email:
ereiss@tiberend.com
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