PDS Biotechnology Expands CRADA with the National Cancer Institute to Include Second Versamune®-Based Anti-Cancer Product
April 29 2020 - 3:05PM
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 an
expansion of its previously announced Cooperative Research and
Development Agreement (CRADA) with the National Cancer Institute
(NCI) to include studies of PDS0103, a Versamune®-based product
incorporating novel mucin-1 (MUC1) epitopes developed by the NCI.
This expansion adds to the NCI’s ongoing evaluation of PDS0101 in
combination with two separate immune-modulating agents, NHS-IL12
and M7824, which will be evaluated in a phase 2 clinical trial in
advanced HPV-associated cancers (NCT04287868).
Under the expanded CRADA, PDS Biotech will
collaborate with the NCI Center for Cancer Research’s Genitourinary
Malignancies Branch (GMB) and the Laboratory of Tumor Immunology
and Biology (LTIB) to conduct preclinical studies of PDS0103, and
potentially human clinical studies in combination with other
therapeutic agents. PDS0103 combines Versamune® with novel highly
immunogenic agonist epitopes of the mucin-1 (MUC1) oncogenic
C-terminal region, designed and developed by the LTIB. PDS0103 is
targeting ovarian, breast, colorectal and lung cancers where
over-expression of MUC1 is associated with a high degree of unmet
need.
“We are excited to further our collaboration
with Dr. Schlom, Dr. Gulley, and their teams at the NCI to progress
the development of PDS0103 and expand the CRADA beyond the
previously announced collaboration involving PDS0101. PDS0103
monotherapy has demonstrated encouraging results in ongoing
preclinical studies,” commented Dr. Bedu-Addo, Chief Executive
Officer of PDS Biotechnology. “Based on the strong T-cell
activation potential of the Versamune®-based products, we believe
that PDS0101 and PDS0103 present an opportunity to improve
immunotherapeutic treatment outcomes across multiple cancer
indications. We look forward to working with the NCI as we jointly
advance the development of PDS0101 and PDS0103.”
Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James
Gulley, Chief, GMB, at NCI will serve as principal investigators
for the NCI for both the PDS0101 and PDS0103 programs, while Dr.
Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech’s Chief Medical
Officer, will serve as the Company’s investigators.
Dr. Julius Strauss, Staff Clinician, LTIB, will
serve as the principal investigator of the phase 2 clinical trial
of PDS0101 in advanced HPV-associated cancers. For patients
interested in enrolling in this clinical study, please call NCI’s
toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:
1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit
the website: https://trials.cancer.gov.
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, 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 partnership with the National Cancer
Institute (NCI), PDS Biotech is advancing a combination of PDS0101,
M7824 and NHS-IL12 to a Phase 2 study in advanced HPV-associated
cancers. A third phase 2 study in advanced localized cervical
cancer combines PDS0101 with standard of care
chemoradiotherapy.
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,” 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) 536-7037Email: tbui@theruthgroup.com /
alobo@theruthgroup.com
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