PDS Biotechnology Initiates Novel Vaccine Development Programs For COVID-19 and Universal Influenza; Delay of PDS0101 VERSATI...
16 April 2020 - 10:30PM
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 an
expanded infectious disease pandemic development program, including
novel vaccines for COVID-19 and universal influenza, in addition to
its previously announced tuberculosis development collaboration
with Farmacore Biotechnology. The Company also announced that
initiation of its multi-center Phase 2 VERSATILE-002 trial for
PDS0101 in advanced/metastatic head and neck cancer has been
delayed due to the severe adverse impact on clinical trial
operations from the COVID-19 pandemic.
PDS Biotech’s products combine its novel
Versamune® technology with custom-designed, disease-specific
proteins to induce both neutralizing antibody and killer (CD8+)
T-cell responses, which when co-induced are more powerful in
fighting disease than either alone. This proven Versamune®
mechanism, combined with a favorable safety profile, provides a
strong rationale to expand the development of Versamune®-based
products beyond its initial series of cancer immunotherapies to add
potentially transformative vaccines to protect and fight against
infectious agents, including COVID-19, influenza, and
tuberculosis.
In the Company’s previously reported Phase I
clinical study of PDS0101 (NCT02065973), Versamune® was
confirmed to be safe and to uniquely facilitate the induction of
strong antigen-specific CD8+ and CD4+ T-cells in vivo, including
memory T-cell responses against the HPV viral target, leading to
regression of disease.
“The potency and versatility of the proprietary
Versamune® T-cell activating platform makes it possible for PDS
Biotech to immediately start development of novel vaccines to
protect against infectious disease agents with pandemic potential,
starting with COVID-19 and influenza,” commented Dr. Frank
Bedu-Addo, CEO of PDS Biotech. “Preventive vaccines to date have
focused on induction of neutralizing antibodies. However, both
neutralizing antibodies and killer (CD8+) T-cells have now been
confirmed to be important in addressing pathogen-induced diseases
such as COVID-19, influenza and tuberculosis. We believe that there
is a clear opportunity to leverage our Versamune® platform to
develop more effective vaccines that have the potential to safely
generate a broader range of immune responses, including antibodies,
killer T-cells, and memory T-cells, to prevent and to provide
long-term protection against the spread of pandemic agents.”
“While we are adding these new programs, we
remain committed to our immuno-oncology programs, including two
upcoming single-site Phase 2 studies – one with the NCI to evaluate
PDS0101 in combination with two promising immuno-modulating agents
in advanced HPV-associated cancers, and another to evaluate the
combination of PDS0101 and chemoradiation in patients with locally
advanced cervical cancer. We will continue to closely monitor
the impact of COVID-19 on these trials and on oncology clinical
trial operations in the US, and will seek to initiate our Phase 2
head and neck cancer trial in the near future if possible,” Dr.
Bedu-Addo concluded.
Dr. Lauren Wood, Chief Medical Officer of PDS
Biotech added, “Versamune® has demonstrated a superior ability to
present viral antigens to our immune system, while simultaneously
activating critical immunological pathways that enable the immune
system to more effectively respond to and protect against disease.
The engineered simplicity, ease of administration, and scalability
of Versamune® also enhances the potential of Versamune®-based
products to better mitigate the devastating impact of emerging
pathogens such as coronaviruses on human health. As we seek to
advance our expanded infectious disease development effort, we look
forward to discussions with relevant government and
non-governmental organizations to determine the most expeditious
path forward into human testing.”
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.
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,” and
other similar expressions among others. Statements that are not
historical facts are forward-looking statements. 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; potential adverse
reactions or changes to business relationships resulting from the
resignation of the Company’s Chief Financial Officer or the
Company’s ability to find a replacement Chief Financial Officerthe
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 timing for
the Company or its partners to initiate the planned clinical trials
for its lead assets, PDS0101 and PDS0102; the Company’s
interpretation of the results of its Phase 1 trial for PDS0101 and
whether such results are sufficient to support additional trials or
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
Tram Bui / Alexander LoboThe Ruth GroupPhone: +1
(646) 536-7035 / +1 (646) 536-7037Email: tbui@theruthgroup.com /
alobo@theruthgroup.com
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