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 updated survival data
from the Phase 2 clinical trial investigating the triple
combination of PDS0101, PDS0301 (IL-12 antibody-drug conjugate) and
an investigational immune checkpoint inhibitor (ICI) in two groups
of advanced cancer patients with various types of human
papillomavirus (HPV) 16-positive cancers. The ICI naïve group had
not responded to standard-of-care treatments but had not yet been
treated with an ICI. The ICI resistant group included patients who
had not responded to multiple prior treatments, including ICI
therapy. Investigators at the National Cancer Institute (NCI), part
of the National Institutes of Health, have completed the primary
endpoint analysis of the Phase 2 trial.
In the ICI naïve group, final survival data from
the trial indicated that 75% (6/8) of these patients were still
alive at 36 months, and the median overall survival (OS) has not
yet been reached. Published data on standard-of-care ICIs report
30-50% of these patients typically remain alive at 12 months, and
less than 30% of the patients remain alive at 24 months.
In the ICI resistant group, the 12-month OS rate
was 72% and the triple combination achieved a median OS of
approximately 20 months. In addition:
- For PDS0101 plus high doses of ICI
and PDS0301, the overall response rate (ORR) was 63% (5/8).
- For PDS0101 plus low doses of ICI
and/or PDS0301, the ORR was 5% (1/21).
- The historical median survival for
ICI therapy in HPV-positive cancer ICI resistant patients is
reported to be 3.4 months.
“We are encouraged by the survival rates for
both ICI naïve and ICI resistant patients with HPV16-positive
cancers who were treated with the triple combination therapy,” said
Frank Bedu-Addo, PhD, Chief Executive Officer of PDS Biotech. “The
ICI resistant data from the VERSATILE-002 trial evaluating PDS0101
in combination with KEYTRUDA® (pembrolizumab) that were reported
October 3, 2023, further clarify the path forward for a potential
registrational clinical trial of PDS0101 and PDS0301 in combination
with a commercial ICI. With this exciting information, we will be
finalizing the regulatory and clinical pathway for the triple
combination with OS as the primary endpoint.”
PDS0101, PDS Biotech’s lead candidate, is a
Versamune® based investigational immunotherapy designed to
stimulate a potent targeted T cell attack against HPV16-positive
cancers. PDS0301 is a novel, proprietary investigational
tumor-targeting IL-12 antibody-drug conjugate that enhances the
proliferation, potency, and longevity of T cells in the tumor
microenvironment formulated to overcome tumor immune suppression
utilizing a different mechanism from checkpoint inhibitors. PDS
Biotech has patented the combination of Versamune® and
IL-12. The investigational ICI used in the triple
combination therapy is Bintrafusp alfa, a bifunctional fusion
protein targeting two independent immunosuppressive pathways (PD-L1
and TGF-β).
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 PDS0301PDS0301 is a novel
investigational tumor-targeting IL-12 antibody-drug conjugate IL-12
that enhances the proliferation, potency and longevity of T cells
in the tumor microenvironment. PDS0301 is given by a subcutaneous
injection. PDS0301 is designed to improve the safety profile of
IL-12 and to enhance the anti-tumor response.
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.
References:Strauss J et al. Journal for
ImmunoTherapy of Cancer 2020;8:e001395Burtness B et al., Lancet.
2019; 394:1915-1928 Ferris RL, et al. NEJM. 2016;375:1856-67
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® is a registered trademark and Infectimune® is a
trademark 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.capital
Media Contact:Gina Cestari6
DegreesPhone: +1 (917) 797-7904Email: gcestari@6degreespr.com
PDS Biotechnology (NASDAQ:PDSB)
Historical Stock Chart
From Apr 2024 to May 2024
PDS Biotechnology (NASDAQ:PDSB)
Historical Stock Chart
From May 2023 to May 2024