PDS Biotech Collaborator Granted NIAID Award to Accelerate Development of Versamune®-Based Universal Influenza Vaccine
July 14 2020 - 8:30AM
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 PDS
Biotech collaborator, Professor J. Woodward of the University of
Kentucky School of Medicine, has been awarded a grant from the
National Institute of Allergy and Infectious Diseases’ (NIAID)
Collaborative Influenza Vaccine Innovation Centers (CIVICs) program
to progress development of a Versamune®-based universal influenza
vaccine.
The key objective of the NIAID’s CIVICs program
is to develop more durable, broadly protective, and longer-lasting
vaccines effective against multiple strains of influenza,
specifically including pandemic strains. Under the award, PDS
Biotech will continue development of its PDS0202 vaccine program,
which combines Versamune® with novel influenza vaccine antigens,
with a goal of rapidly progressing into a human clinical trial.
Preclinical development studies will be performed at
three sites: PDS Biotech’s Princeton, NJ laboratories, The
University of Kentucky School of Medicine, and the CIVICs Center
for Influenza Vaccine Research for High-Risk Populations
(CIVR-HRP).
“We are excited to accelerate PDS0202
development to further demonstrate Versamune®’s ability to induce
the immune system to generate high levels of neutralizing
antibodies, killer T-cells, and long acting memory T-cells, that
for PDS0202 could provide broad and long-term protection against
multiple influenza strains,” commented Dr. Frank Bedu-Addo, Chief
Executive Officer of PDS Biotech. “NIAID support for the upcoming
PDS0202 preclinical studies could speed development of a more
durable and broadly protective influenza vaccine, thus reducing the
public health consequences of both seasonal and pandemic
influenza.”
PDS Biotech’s infectious disease portfolio
consists of PDS0201 (tuberculosis), PDS0202 (universal flu) and
PDS0203 (COVID-19), all of which are based on the Versamune®
platform and are designed to induce a broad range of long-term
protective immune responses against these pathogens.
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 PDS0201
PDS0201 is an investigational vaccine designed
for the prevention of tuberculosis. PDS0201 combines the
utility of the Versamune® platform with bacillus Mycobacterium
tuberculosis (M. tuberculosis) antigens. Tuberculosis (TB) is the
leading cause of death from a single infectious agent and is caused
by the bacillus M. tuberculosis, which is spread when people who
are sick with TB expel bacteria into the air. About a quarter of
the world’s population is infected with M. tuberculosis and thus at
risk of developing TB disease. PDS0201 is currently in
preclinical development.
About PDS0202
PDS0202 is an investigational vaccine designed
for the prevention of a broad range of influenza strains. PDS0202
combines the utility of the Versamune® platform with a mix of
influenza antigens including conserved regions of the virus.
Influenza is estimated to result in about 3 to 5 million cases of
severe illness, and about 290,000 to 650,000 respiratory deaths
globally. Some strains of influenza are known to have strong
pandemic potential. PDS0202 is currently in preclinical
development.
About PDS0203
PDS0203 is a COVID-19 vaccine candidate that
combines the utility of the Versamune® platform with a mix of
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
antigens. The World Health Organization (WHO) declared the
COVID-19 outbreak caused by a novel coronavirus, Severe Acute
Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), a global health
emergency in January of 2020. Within three months of initial
discovery COVID-19 was declared a global pandemic, reflecting
alarming levels of spread and severity and resulting in
unprecedented action by local and national governments to restrict
the movement of citizens to contain the spread. Building
immunity to the disease is the key to stopping its spread. A
COVID-19 vaccine would train the immune system to recognize and
destroy the virus without the vaccinated person getting sick.
PDS0203 is currently in preclinical development.
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; 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 timing for the Company or its
partners to initiate the planned clinical trials for its lead
assets, PDS0101; 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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