PDS Biotech Announces Clinical Trial of Its Lead Immunotherapy Product, PDS0101, in Combination with Chemoradiotherapy in Adv...
June 04 2020 - 4:05PM
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing novel cancer therapies and
infectious disease vaccines based on the Company’s proprietary
Versamune® T-cell activating technology, today announced a Phase 2
clinical trial to evaluate its lead immunotherapy product, PDS0101,
in combination with standard of care chemoradiotherapy for
treatment of locally advanced cervical cancer.
The clinical trial will be conducted at The
University of Texas MD Anderson Cancer Center and the Lyndon B.
Johnson Hospital in Houston by Ann H. Klopp, M.D., Ph.D., Associate
Professor of Radiation Oncology and Olsi Gjyshi, M.D., Ph.D. The
clinical trial will investigate the safety and anti-tumor efficacy
of the PDS0101-chemoradiation combination, and their correlation
with critical biomarkers of an immune response in patients with
locally advanced cervical cancer.
On September 19, 2019, PDS Biotech announced the
results of a PDS0101 Phase 1 clinical study in cervical neoplasia
(pre-cervical cancer) patients. PDS0101 is being developed to
treat multiple cancers associated with HPV infection, including
anal, cervical and head and neck cancers. In the Phase 1
study, PDS0101 demonstrated potent in vivo induction of active
killer T-cells that target cancer cells containing the
cancer-causing HPV proteins, as well as an excellent safety profile
with no limiting toxicities. Treatment with PDS0101 resulted
in complete lesion regression in most of the patients. HPV
infection is responsible for over 99% of cervical cancers.
PDS Biotech currently anticipates initiating this clinical study
within a few months.
“We are pleased to announce this Phase 2
clinical trial being performed to further validate our novel
Versamune®-based immunotherapy platform and lead asset PDS0101,”
said Dr. Frank Bedu-Addo, CEO of PDS Biotech. “We look forward to
investigating PDS0101 as a potentially safe and effective
immunotherapeutic combination with standard of care
chemoradiotherapy to improve the treatment options for women with
locally advanced cervical cancer.”
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company with a
growing pipeline of cancer immunotherapies and infectious disease
vaccines based on the Company’s proprietary Versamune® T-cell
activating technology platform. Versamune® effectively delivers
disease-specific antigens for in vivo uptake and processing, while
also activating the critical type 1 interferon immunological
pathway, resulting in production of potent disease-specific killer
T-cells as well as neutralizing antibodies. PDS Biotech has
engineered multiple therapies, based on combinations of Versamune®
and disease-specific antigens, designed to train the immune system
to better recognize disease cells and effectively attack and
destroy them. To learn more, please visit www.pdsbiotech.com
or follow us on Twitter at @PDSBiotech.
About PDS0101
PDS Biotech’s lead candidate, PDS0101, combines
the utility of the Versamune® platform with targeted antigens in
HPV-expressing cancers. In separate partnerships with Merck
and Co. and the National Cancer Institute (NCI), PDS Biotech is
preparing to initiate two additional Phase 2 studies in head and
neck cancer and in HPV-related advanced cancer respectively.
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,” and
other similar expressions among others. Statements that are not
historical facts are forward-looking statements. 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 timing for the Company or its
partners to initiate the planned clinical trials for its lead asset
PDS0101; the Company’s interpretation of the results of its Phase 1
trial for PDS0101 and whether such results are sufficient to
support additional trials or 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 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
acceptance by the market of the Company’s product candidates, if
approved; the timing of and the Company’s ability to obtain
and maintain U.S. Food and Drug Administration or other
regulatory authority approval of, or other action with respect to,
the Company’s product candidates; and other factors, including
legislative, regulatory, political and economic
developments not within the Company’s control, including
unforeseen circumstances or other disruptions to normal business
operations arising from or related to COVID-19. 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 risk factors included in the
Company’s annual and periodic reports filed with the SEC. 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.
Media & Investor Relations
Contact:
Deanne RandolphPDS BiotechPhone: +1 (908)
517-3613Email: drandolph@pdsbiotech.com
Tram Bui / Alexander LoboThe Ruth GroupPhone: +1
(646) 536-7035 / +1 (646) 536-7037 Email:
tbui@theruthgroup.com / alobo@theruthgroup.com
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