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 publication of abstract #2501 by the American
Society of Clinical Oncology (ASCO). The abstract summarizing
interim data from the National Cancer Institute (NCI)-led phase 2
trial has been accepted for oral presentation at the 2021 ASCO
Annual Meeting taking place June 4-8. The presentation, scheduled
for June 7, is expected to include results from a larger sample
than the 14 patients included in the abstract.
Additional data highlights from abstract #2501
include:
- An overall objective response rate
of 71% (10/14) in patients with refractory HPV16-associated cancers
- 1 complete response (anal cancer)
- 9 partial responses (3 cervical cancer, 2 vulvar/vaginal
cancer, 2 anal cancer, 2 oropharyngeal cancer)
- 90% of these of these responses are
ongoing after a median 5 months of follow up (9/10)
The NCI Center for Cancer Research’s Laboratory
of Tumor Immunology and Biology (LTIB) and Genitourinary
Malignancies Branch (GMB) are jointly leading this Phase 2 trial
(NCT04287868), 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. Bintrafusp alfa
is being jointly developed by Merck KGaA, Darmstadt, Germany, and
GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA,
Darmstadt, Germany.
The trial is evaluating the treatment
combination in both checkpoint inhibitor naïve and refractory
patients with advanced human papillomavirus (HPV)-associated
cancers that have progressed or returned after treatment. Objective
response is measured by radiographic tumor responses according to
RECIST 1.1. These reported data validate the preclinical studies
published by the NCI demonstrating that the complementary
mechanisms of action of the three immunotherapies which involve
potent in-vivo HPV16-specific killer and helper T-cell induction
with effective T-cell tumor infiltration, blocking of immune
checkpoints as well as targeting of TGF-β resulted in superior
tumor regression.“The achievement of a 71% objective response rate
in a difficult to treat patient population continues to strengthen
the evidence of our novel Versamune® platform’s potential ability
to induce high levels of tumor-specific CD8+ killer T-cells that
attack the cancer resulting in strong synergy with Bintrafusp alfa
and NHS-IL12, thus leading to effective tumor regression,”
commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech.
“The initial data solidifies our belief that PDS0101’s published
preclinical efficacy, when combined with these two
immune-modulating agents, demonstrates the potential to
significantly improve clinical outcomes for patients with advanced,
refractory HPV-associated cancers who have limited treatment
options.”
There are more than 630,000 cases of
HPV-associated malignancies including cervical, oropharyngeal and
anal cancer worldwide annually. HPV 16 is responsible for most of
these cases. About 15-20% of HPV-associated malignancies respond to
PD-(L)1 inhibitors. However, for the overwhelming majority of
patients who progress on these immunotherapies there is no
effective standard of care therapy.
The abstract is now available online on the ASCO
conference website: https://am.asco.org/.
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
Dr. Julius Strauss, Staff Clinician, LTIB, is
serving as the Principal Investigator of this phase 2 clinical
trial 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 developing a growing pipeline of cancer immunotherapies and
infectious disease vaccines based on the Company’s proprietary
Versamune® T-cell activating technology platform. Our
Versamune®-based products may 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
investigational 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. Our immuno-oncology product candidates are initially being
studied in combination therapy to potentially enhance efficacy
without compounding toxicity across a range of cancer types. The
company’s lead investigational cancer immunotherapy product PDS0101
is currently in Phase 2 clinical studies in HPV-associated 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 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; 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*Updated data and results to be presented in
June at the ASCO meeting1C.S. Rumfield et al., J. Journal for
ImmunoTherapy of Cancer 2020;8:e000612.
doi:10.1136/jitc-2020-000612)2S. Gandhapudi et al, J. Immunology,
2019 (202), 1215
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