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 the submission to the
U.S. Food and Drug Administration (FDA) of an updated Chemistry,
Manufacturing and Controls (CMC) package and a Phase 3 multicenter
registrational protocol to the company’s Investigational New Drug
(IND) submission to evaluate the combination of PDS0101 and
KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the
treatment of recurrent or metastatic human papillomavirus (HPV)
16-positive head and neck squamous cell carcinoma (HNSCC). The
protocol was developed in accordance with guidance from the FDA on
key elements of the Phase 3 program to support the eventual
submission of a Biologics License Application (BLA).
The Phase 3 trial, named VERSATILE-003, is a
randomized, active comparator-controlled study designed to
investigate the safety and efficacy of PDS0101 combined with
KEYTRUDA® compared to KEYTRUDA® monotherapy in immune checkpoint
inhibitor (ICI)-naïve patients with recurrent or metastatic
HPV16-positive HNSCC. The primary efficacy endpoint for
VERSATILE-003, per the protocol, is overall survival (OS). The
Phase 3 study is expected to involve approximately 90-100 clinical
sites globally. PDS Biotech anticipates initiating the
VERSATILE-003 Phase 3 trial in the fourth quarter of 2023.
“Submission of the protocol and supportive CMC
documents for this Phase 3 registrational trial is an important
milestone for PDS Biotech and our VERSATILE-003 program
investigating PDS0101 in combination with KEYTRUDA® as a potential
treatment for recurrent or metastatic HPV16-positive HNSCC,” stated
Dr. Lauren V. Wood, PDS Biotech’s Chief Medical Officer. “Interim
data from our ongoing VERSATILE-002 Phase 2 clinical trial have
been very encouraging, with impressive interim OS and PFS results.
With VERSATILE-003, we have an opportunity to confirm the Phase 2
results from VERSATILE-002 in a controlled, Phase 3 clinical trial
comparing the combination of PDS0101 and KEYTRUDA® to KEYTRUDA®
monotherapy.”
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 suggest 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.
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, and Grade 3
treatment related adverse events were observed in 8% of
patients.
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) versus KEYTRUDA® monotherapy. 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.
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.
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 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 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, Inc. Phone: +1 (609) 468-9325 Email:
dschemelia@tiberend.com
Eric ReissTiberend Strategic Advisors,
Inc. Phone: +1 (802) 249-1136Email:
ereiss@tiberend.com
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