PDS Biotech Provides Update on National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination
21 October 2021 - 10:30PM
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing novel cancer therapies based on
the Company’s proprietary Versamune® T-cell activating technology,
today announced the temporary suspension of recruitment in the
National Cancer Institute (NCI)-led Phase 2 clinical trial
(NCT04287868) evaluating PDS0101 (Versamune®-HPV16) in combination
with two investigational immune-modulating agents in advanced HPV
cancers.
The issue is not specific to the PDS0101 trial
and is unrelated to any safety or efficacy concerns with the triple
combination. The NCI anticipates that the issue should be resolved
timely, at which time the PDS0101 trial recruitment will resume.
The timing of clinical data resulting from this trial is not
expected to be affected by the recruitment suspension.
“We know from the interim data that this
combination has the potential to significantly improve clinical
outcomes for patients with advanced, refractory HPV16-associated
cancers who have limited treatment options. While the trial is
experiencing a slight administrative delay, we are pleased to
report that the PDS0101 trial recruitment has progressed well and
it is anticipated that it will resume recruitment shortly. We
believe, based on the previously reported results, that this
treatment could significantly improve survival benefit for these
patients, and we look forward to resumption of the trial in the
near term,” said Dr. Lauren V. Wood, PDS Biotech’s Chief Medical
Officer.
The trial is evaluating the novel combination in
both checkpoint inhibitor naïve and refractory patients with
advanced HPV-associated cancers that have progressed or returned
after treatment. The vast majority of these cancers are caused by
HPV16. About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy
company developing a growing pipeline of cancer immunotherapies
based on the Company’s proprietary Versamune® T-cell activating
technology platform. Our Versamune®-based products have
demonstrated the potential to overcome the limitations of current
immunotherapy by inducing in vivo, large quantities of
high-quality, highly potent polyfunctional tumor specific CD4+
helper and CD8+ killer T-cells. PDS Biotech has developed multiple
therapies, based on combinations of Versamune® and disease-specific
antigens, designed to train the immune system to better recognize
diseased cells and effectively attack and destroy them. The
company’s pipeline products address various cancers including
breast, colon, lung, prostate and ovarian cancers. 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 evaluating a combination of PDS0101 and KEYTRUDA® in a
Phase 2 study in first-line treatment of recurrent or metastatic
head and neck cancer. PDS Biotech is also conducting two additional
Phase 2 studies in advanced HPV-associated cancers and advanced
localized cervical cancer with the National Cancer Institute (NCI)
and The University of Texas MD Anderson Cancer Center,
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,” “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® based
products; 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® based products 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 our ability to fully fund our disclosed clinical trials,
which assumes no material changes to our currently projected
expenses), futility analyses, presentations at conferences and data
reported in an abstract, and receipt of interim results, 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; 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
Rich CockrellCG CapitalPhone: +1 (404) 736-3838
Email: rich@cg.capital
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