PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing a growing pipeline of targeted
cancer immunotherapies and infectious disease vaccines based on the
Company’s proprietary Versamune® and Infectimune™ T cell activating
technologies, today announced that an abstract reporting on interim
data from a first-in-human clinical trial evaluating the
combination of PDS0301, an IL-12-based immunocytokine, with the
chemotherapy medication docetaxel has been accepted for oral
presentation at the 11th Annual Meeting of the International
Cytokine & Interferon Society (Cytokines 2023).
The abstract, titled, “Combining an IL-12-based
Immunocytokine (PDS0301) with Docetaxel in Metastatic Prostate
Cancer: Preliminary Safety and Immune Data”, will report interim
safety and immune data on 18 patients in the clinical trial being
led by the National Cancer Institute (NCI), part of the National
Institutes of Health. The trial is investigating the safety, immune
responses and clinical activity of PDS0301 and docetaxel in
metastatic castration-sensitive and castration-resistant prostate
cancer patients. The study is designed to evaluate three dose
levels of PDS0301 (8 mcg/kg, 12 mcg/kg, and 16.8 mcg/kg) in
combination with docetaxel (75 mg/m2) administered every three
weeks.
“We look forward to Dr. Ravi Madan’s
presentation of the interim safety, clinical outcomes and immune
correlates for PDS0301 administered in combination with standard of
care docetaxel in patients with advanced prostate cancer,” stated
Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “This
clinical trial provides an important opportunity to investigate the
potential of PDS0301 combined with docetaxel chemotherapy to offer
improved treatment options for patients with metastatic
castration-sensitive and castration-resistant forms of prostate
cancer. The results of this study could provide insight into the
potential use of PDS0301 with chemotherapy across multiple solid
tumors.”
Abstract Title: Combining an
IL-12-based Immunocytokine (PDS0301) with Docetaxel in Metastatic
Prostate Cancer: Preliminary Safety and Immune DataPaper
Number: 249Presenting Author: Head,
Prostate Cancer Clinical Research Section, Ravi A.
MadanAuthors: Renee Donahue, Yo-Ting Tsai,
Mohammad O. Atiq, Elias Chandran, Luke Meininger, Fatima Karzai,
Marijo Bilusic, Jennifer Marte, Philip M. Arlen, Lisa Cordes, Megan
Hausler, Amy Hankin, Nikki Williams, William D. Figg, Jeff Schlom,
James L. Gulley, Ravi A. MadanSession Details:
Plenary 3: Cytokines in Cancer Immunity and Immunotherapy,
Mittwoch; Olympia A+BSession Date and Time:
October 18, 2023, 10:00-10:15
For patients interested in enrolling in this
clinical trial, please contact NCI’s toll-free number
1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or
the Web
site: https://trials.cancer.gov and/or NCIMO_referrals@mail.nih.gov.
About PDS0301PDS0301 is a novel
investigational tumor-targeting antibody-conjugated Interleukin 12
(IL-12) that enhances the proliferation, potency and longevity of T
cells and natural killer (NK) cells in the tumor microenvironment.
PDS0301 is given by subcutaneous injection and 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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