PDS Biotech Announces Oral Presentation of PDS0101 Data by the National Cancer Institute at 2021 American Society of Clinical...
April 29 2021 - 7:30AM
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
initial efficacy and safety data from the National Cancer
Institute’s (NCI) Phase 2 clinical study of PDS0101 for the
treatment of advanced human papillomavirus (HPV)-associated cancers
that have progressed or returned after treatment (NCT04287868) has
been accepted for oral presentation at the American Society of
Clinical Oncology (ASCO) 2021 Annual Meeting taking place June 4-8.
The accepted abstract summarizes initial
findings from the ongoing trial, which studies PDS0101 in
combination with two investigational immune-modulating agents:
bintrafusp alfa (M7824), a bifunctional “trap” fusion protein
targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting
immunocytokine. Earlier this year, it was announced that the trial
had achieved its preliminary efficacy threshold of an objective
response in 3 or more of the first 8 patients as measured by RECIST
1.1. The trial subsequently expanded enrollment to both checkpoint
inhibitor naïve patients and patients who have failed prior therapy
with checkpoint inhibitors. “We are encouraged by the data and look
forward to the presentation of initial findings from the study,”
said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech.
“ASCO provides an important opportunity to share the potential of
both PDS0101 and the Versamune® platform with the research and
medical community.”
Abstract Number: 2501Abstract Title: Phase II
evaluation of the triple combination of PDS0101, M9241, and
bintrafusp alfa in patients with HPV 16 positive malignancies.
Presenting Author: Julius Strauss, MD, National
Cancer InstituteSession: Developmental Therapeutics—Immunotherapy
Date: June 7, 2021Time: 3:00 PM-6:00 PM EDT
The abstract will be available on Wednesday, May
19 at 5:00 PM EDT on ASCO.org.
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. The company’s
lead investigational cancer immunotherapy product PDS0101 is
currently in Phase 2 clinical studies in multiple indications.
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 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. 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 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; 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 Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital
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