PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing a growing pipeline of targeted
immunotherapies for cancer and infectious disease, today announced
the Canadian Intellectual Property Office has allowed patent number
2,876,656 titled, “Cationic Lipid Vaccine Combinations and Methods
of Use,” governing composition of matter and uses for Versamune®
(R-DOTAP) in combination with PDS0301. The intellectual property
provides broad protection for treatments utilizing Versamune® based
therapies, including PDS0101, in combination with PDS0301 as a
potential treatment for cancer. This patent expands PDS Biotech’s
market coverage and adds to the world-wide patent portfolio
including the patent granted by the United States Patent and
Trademark Office (USPTO), U.S. Patent No. 11,401,306, covering the
combination of Versamune® and cytokines including Interleukin 12
(IL-12).
The Canadian patent will protect the capability
of the composition of Versamune® and PDS0301 to reduce the
population of a well-documented population of cells called myeloid
derived suppressor cells (MDSC) that enable the cancer to escape
attack by T cells. The composition, when administered with a tumor
antigen, enhances the Versamune® induced anti-tumor response.
Suppression of anti-tumor immune responses is a major mechanism by
which tumor cells escape attack by T cells. MDSCs are reported to
be the key immunosuppressive cells present in the tumor that
protect the cancer’s ability to grow and are a major obstacle to
effective cancer immunotherapy.
“This newly allowed patent adds to the
intellectual property governing Versamune® based therapies in
combination with PDS0301, which we believe represent a potentially
transformative treatment approach for advanced cancer patients,”
said Dr. Frank Bedu-Addo, CEO of PDS Biotech. “Possessing
multilayered IP for our immunotherapies is an important value
driver for PDS Biotech and is a key component of our business
strategy. We anticipate that Canada will constitute an important
market as we begin our commercialization and partnership
strategies.”
In December 2022, PDS Biotech provided an update
on the National Cancer Institute led study of a combination of
PDS0101, PDS0301 and an immune checkpoint inhibitor (ICI) in
patients with various types of human papillomavirus (HPV)
16-positive cancers who had failed all prior treatments including
ICI therapy. These patients have a historical median overall
survival (OS) of 3-4 months on ICI therapy. This combination
achieved a median overall survival of 21 months reported in 29
patients. In the patients who had not received prior ICI therapy,
median OS had not yet been reached at 27 months, and an objective
response rate of 88% (7/8) and complete response in 38% (3/8) of
patients was reported. In similar ICI naïve patients on a
combination of ICI therapy and chemotherapy, the published median
OS is approximately 13 months and objective response is
approximately 35%. Similar results with the combination of PDS0101,
PDS0301 and an ICI were seen in all types of HPV-positive advanced
cancers including anal, cervical, head and neck, vaginal and
vulvar.
PDS Biotech’s exclusive rights to the
combination of PDS0101 and PDS0301 permits it to design
compositions and methods that overcome tumor immune suppression
utilizing a different mechanism from checkpoint inhibitors.
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 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
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 antibody-conjugated Interleukin 12 (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 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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