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 reopening 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 suspension of recruitment was administrative
in nature and was unrelated to any specific safety or efficacy
concerns associated with the triple combination being studied. As a
result, during the recruitment suspension, patients already
enrolled in the study continued to receive scheduled treatment. The
timing of clinical results from this trial is not expected to be
affected by the pause in recruitment of new patients.
The trial is evaluating the novel triple
combination in two groups of patients. Firstly, in second line
treatment of recurrent or metastatic HPV-positive cancers including
anal, cervical, head and neck, penile, vaginal, and vulvar cancers
in patients who are naïve to checkpoint inhibitors and have not
responded to at least one standard of care therapy. Secondly in
third line treatment of the above recurrent or metastatic
HPV-positive cancers in patients who have not responded to at least
two standard of care therapies including checkpoint inhibitor
treatment.
“We are pleased that the NCI, part of the
National Institutes of Health, quickly obtained IRB approval to
resume recruitment in this important trial. We believe the interim
data demonstrated that this combination has the potential to
significantly improve clinical outcomes for patients with advanced,
refractory HPV16-positive cancers who have limited treatment
options. Our approach of treating multiple types of cancer based on
their molecular profiles rather than tissue location, may have the
potential to provide safe Versamune®-based treatment options to an
expanded population of patients suffering from multiple types of
cancer and at different stages of disease,” said Dr. Lauren V.
Wood, PDS Biotech’s Chief Medical Officer.
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 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 HPV16-expressing cancers. In partnership with Merck & Co.,
PDS Biotech is evaluating a combination of PDS0101 and
KEYTRUDA® in a Phase 2 study (NCT04260126) in first-line
treatment of recurrent or metastatic head and neck cancer, and also
in second line treatment of recurrent or metastatic head and neck
cancer in patients who have failed prior checkpoint inhibitor
therapy. PDS Biotech is also conducting a Phase 2 clinical study in
both second- and third-line treatment of multiple advanced
HPV-associated cancers with the National Cancer Institute (NCI). A
third Phase 2 clinical trial in first line treatment of locally
advanced cervical cancer is being performed with The University of
Texas, MD Anderson Cancer Center.
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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