PDS Biotech Announces Publication of Preclinical Results of PDS0101 Combination by the National Cancer Institute in the Journ...
June 22 2020 - 8:30AM
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 the
publication of data generated by the National Cancer Institute
(NCI) based on preclinical studies of PDS Biotech’s lead clinical
program, PDS0101, in combination with two other investigational
anti-cancer agents. The article “Immunomodulation to enhance
the efficacy of an HPV therapeutic vaccine” by Rumfield et al. was
published in the Journal for ImmunoTherapy of Cancer, and provides
strong rationale for clinical evaluation of this three-component
treatment combination in a recently initiated NCI-led Phase 2
clinical trial.
The results of the NCI’s preclinical study
indicated that PDS0101 generated both human papillomavirus
(HPV)-specific T-cells and an associated antitumor response when
used as a monotherapy. When PDS0101 was combined with two
other development-stage anti-cancer agents, Bintrafusp alfa (M7824)
and NHS-IL12, the data suggest the agents worked synergistically to
provide enhanced tumor regression and T-cell response as compared
to the agents alone.
Dr. Frank Bedu-Addo, PDS Biotech’s Chief
Executive Officer, commented, "The results of this preclinical
study highlight the potential of PDS0101, Bintrafusp alfa (M7824)
and NHS-IL12 when administered in combination, to improve treatment
outcomes in patients with advanced HPV-associated cancers such as
anal, cervical, head and neck and vulvar cancers. We look
forward to progressing development of this triple therapeutic
combination in the upcoming Phase 2 study in patients with
HPV-associated cancers.”
The studies detailed in the Journal for
ImmunoTherapy of Cancer were conducted under an existing
Cooperative Research and Development Agreement (CRADA) between PDS
Biotech and the NCI. The CRADA includes collaborative development
work on both PDS0101 and a second development stage compound,
PDS0103.
The full publication can be accessed here.
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 partnership with Merck and Co.,
PDS Biotech is advancing a combination of PDS0101 and KEYTRUDA® to
a Phase 2 study in first line treatment of recurrent or metastatic
head and neck cancer. In separate partnership with the National
Cancer Institute (NCI), and The University of Texas MD Anderson
Cancer Center, PDS Biotech is conducting additional Phase 2 studies
in advanced HPV-associated cancers and advanced localized cervical
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 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) 536-7037Email: tbui@theruthgroup.com /
alobo@theruthgroup.com
PDS Biotechnology (NASDAQ:PDSB)
Historical Stock Chart
From Mar 2024 to Apr 2024
PDS Biotechnology (NASDAQ:PDSB)
Historical Stock Chart
From Apr 2023 to Apr 2024