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PDSB - PDS Biotechnology News Story

$6.28 -0.1  -2.0%

Last Trade - 19/01/22

Small Cap
Market Cap £134.1m
Enterprise Value £82.8m
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PDS Biotech and Farmacore Announce Updates to Co-Development of Versamune®-Based COVID-19 Vaccine

Tue 10th November, 2020 9:05pm
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FLORHAM PARK, N.J., Nov. 10, 2020 (GLOBE NEWSWIRE) -- 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 progress on its co-development program with Farmacore Biotechnology
for a Versamune®-based vaccine aimed at preventing COVID-19 infection.

Based on promising and robust preclinical data with PDS0203, and in the
interest of rapid development, PDS Biotech and Farmacore have jointly
prioritized advancement of PDS0203 to human clinical trials. PDS Biotech had
previously announced the parallel development of two Versamune®-based
COVID-19 vaccines PDS0203 and PDS0204 each containing different SARS-CoV-2
proteins. The decision to jointly develop PDS0203 was made with the support of
the Agência Nacional de Vigilância Sanitária (ANVISA) following a
successful pre-investigational new drug meeting on November 06, 2020. ANVISA
and Farmacore reviewed the PDS0203 data and agreed on the path forward for
official submission of a final data package and the phase 1/2 human clinical
trial protocol. Farmacore is in discussions with specific agencies of the
government to extend the preclinical funding to cover the upcoming human
clinical trial anticipated to begin during the first half of 2021.

As previously disclosed, PDS Biotech has generated robust preclinical data
demonstrating that PDS0203 elicits a 30-45 fold increase in the induction of
highly active and potent virus-specific T-cells within 14 days of treatment
compared to the vaccine without Versamune®. Importantly, the study also
demonstrated induction of the long-lasting virus-specific memory T-cells
necessary for longer term protection. The vaccine has also demonstrated strong
and long-lasting induction of neutralizing antibodies. The PDS0203 subunit
vaccine is based on recombinant proteins and does not require the use of
inactivated viruses, traditional adjuvants, DNA or RNA to induce robust
protective immune responses.

“PDS0203 may present strong potential to provide the breadth and level of
immune responses necessary for a safe and effective vaccine with long-term
protection against COVID-19," said Dr. Greg Conn, Chief Scientific Officer of
PDS Biotechnology.

“PDS Biotech and Farmacore are now one step closer to advancing our
Versamune®-based COVID-19 vaccine into the clinic,” said Dr. Frank
Bedu-Addo, Chief Executive Officer of PDS Biotech. “The preclinical results
of PDS0203 demonstrate its potential to induce a robust and broad immune
response. We look forward to evaluating our next-generation vaccine in planned
human clinical trials in partnership with Farmacore and to advance our
understanding of the potential of novel Versamune®-based vaccines like
PDS0203 to provide long-term protection against infection with viruses such as

“In this global pandemic, it is incumbent upon the scientific community to
be flexible and to ensure we are prioritizing the vaccine with the most
clinical potential and that we can progress most quickly,” said Helena
Faccioli, CEO of Farmacore. “We are excited to continue advancing the
partnership with PDS Biotech, and we are thrilled to have the support of
ANVISA to provide the opportunity to develop a treatment in Brazil in the
fight against this pandemic.”

The companies plan to utilize multiple research and development sites in the
United States and Brazil to progress preclinical and clinical development
PDS0203.  Farmacore will lead the regulatory and clinical trial efforts in
Brazil while PDS Biotech will continue to contribute scientific expertise and
operational support.

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 Farmacore

Farmacore is a biotechnology company, founded in 2005 as a startup, focusing
on R&D of innovative immunobiological products for use in the human and
veterinary health sectors. It is a technology-based company that conducts
research and development of biotechnological products and processes for the
human and veterinary sectors. It develops innovative biotechnological and
immunobiological products and adds value to them in all stages of development,
from project design to biomolecule production www.farmacore.com.br.

About PDS0203

PDS0203 is an investigational vaccine designed for the prevention of COVID-19
being jointly developed by PDS Biotech and Farmacore. PDS0203 combines the
utility of PDS Biotech’s Versamune® platform with a recombinant native
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein
recognizable by our immune system (antigen). The Versamune® platform, due to
its unique ability to induce both antibody and T-cell responses is being
utilized to develop a next generation vaccine that may more effectively
prevent COVID-19.

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 Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Jacob Goldberger
CG Capital
Phone: +1 (404) 736-3841
Email: jacob@cg.capital


GlobeNewswire, Inc. 2020
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