PDS Biotech Announces Initiation of Phase 2 Trial of PDS0101 Led by the National Cancer Institute
June 15 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 that the
first patient has been dosed in the National Cancer Institute’s
(NCI) Phase 2 clinical study of PDS0101 in the treatment of
advanced human papillomavirus (HPV) associated cancers. This
clinical trial involves a combination of PDS0101 with two clinical
development-stage immune-modulating agents, Bintrafusp alfa (M7824)
and NHS-IL12.
The NCI Center for Cancer Research’s
Genitourinary Malignancies Branch (GMB) and Laboratory of Tumor
Immunology and Biology (LTIB) are jointly leading this Phase 2
trial evaluating PDS0101, which combines the Versamune® platform
with targeted antigens in HPV-expressing cancers, in combination
with Bintrafusp alfa (M7824) and NHS-IL12.
The trial will evaluate the objective response
rate of this novel triple combination in approximately 35 patients
with advanced HPV-associated cancers. The first eight patients will
be evaluated for safety and objective response before the trial
progresses to full enrollment.
“We are excited to have the first patient dosed
in this NCI-led Phase 2 clinical trial, which is an important next
step in further demonstrating the power of our novel Versamune®
platform to induce high levels of tumor-specific CD8 killer
T-cells,” commented Dr. Lauren Wood, Chief Medical Officer of PDS
Biotech. “We believe that PDS0101’s demonstrated preclinical
efficacy when combined with these two immune-modulating agents, has
the potential to significantly improve clinical outcomes for
patients with advanced HPV-associated cancers.”
Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James
Gulley, Chief, GMB, at NCI are serving as principal investigators
for the NCI, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS
Biotech’s Chief Executive Officer and Chief Medical Officer
respectively, will serve as PDS Biotech’s investigators. The
studies are being performed as part of a Cooperative Research and
Development Agreement (CRADA) between PDS Biotech and the NCI.
Dr. Julius Strauss, Staff Clinician, LTIB, is
serving as the principal investigator of this 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 & 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 partnership with the National Cancer
Institute (NCI), PDS Biotech is also advancing a combination of
PDS0101 and two clinical stage immunotherapies to a Phase 2 study
in advanced HPV-associated cancers. A third phase 2 study is to be
performed in advanced localized cervical cancer combining PDS0101
with standard of care chemoradiotherapy.
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
assets, 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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