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
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 achieved
its preliminary objective response. The trial, which studies
PDS0101 in combination with two investigational immune-modulating
agents bintrafusp alfa (M7824), a TGF-β “trap”/ anti-PD-L1
bifunctional fusion protein, and NHS-IL12 (M9241), a DNA-targeted
immunocytokine, will now progress to full enrollment of
approximately 20 in this group of checkpoint inhibitor (CPI) naïve
patients. As a result of achieving this milestone,
preliminary efficacy assessment of the triple combination in an
added group of approximately 20 patients who have failed prior
therapy with checkpoint inhibitors (CPI refractory) is ongoing.
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.
The trial is evaluating the treatment combination in two patient
groups: one in patients who failed prior treatment, but are naïve
to checkpoint inhibitor treatment; and the second in patients who
have failed treatment with checkpoint inhibitors. As prespecified
in the clinical trial design, the achievement of an objective
response as measured by radiographic tumor responses according to
RECIST 1.1 or iRECIST among at least three of the first eight
patients allows the trial to progress to full enrollment.
Pooled data from phase 1 and 2 trials reported
in the October 2020 issue of the Journal for Immunotherapy of
Cancer (J ImmunoTher Cancer 2020;8:e001395.
doi:10.1136/jitc-2020-001395) showed that bintrafusp alfa (M7824) a
first-in-class bifunctional fusion protein composed of the
extracellular domain of human TGF-β (TGF-β “trap”) fused to an IgG1
antibody blocking PD-L1 (anti–PD-L1) protein, demonstrated efficacy
in checkpoint inhibitor-naïve patients with HPV-associated
malignancies. The observed response rate was 30.5%. M9241 is an
immunocytokine composed of 2 heterodimers of IL-12 fused to the
heavy chains of a human antibody targeting DNA released from
necrotic tumor cells. In preclinical studies performed at the NCI
comparing each drug alone versus all three agents used in
combination, the triple combination achieved the highest induction
of tumor-specific CD8+ killer T-cells and superior antitumor effect
(J ImmunoTher Cancer 2020;8:e000612.
doi:10.1136/jitc-2020-000612).
“The achievement of this important milestone in
this NCI-led Phase 2 clinical trial strengthens 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 to
achieve tumor regression,” commented Dr. Lauren Wood, Chief Medical
Officer of PDS Biotech. “The initial data solidifies our belief
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
and currently untreatable HPV-associated cancers.”
The studies are being performed as part of a
Cooperative Research and Development Agreement (CRADA) between PDS
Biotech and the NCI. 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, are serving as PDS Biotech’s investigators.
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), email
NCIMO_Referrals@mail.nih.gov, 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 and Co.,
PDS Biotech is studying a combination of PDS0101 and KEYTRUDA® to a
Phase 2 study in first-line treatment of recurrent or metastatic
head and neck cancer. In separate partnership with the National
Cancer Institute (NCI), and The University of Texas MD Anderson
Cancer Center, PDS Biotech is conducting additional Phase 2 studies
in advanced HPV-associated cancers and advanced localized cervical
cancer 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
its lead asset PDS0101; 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
Jacob GoldbergerCG CapitalPhone: +1 (404)
736-3841 Email: jacob@cg.capital
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