PDS Biotechnology and Farmacore Biotechnology Announce Co-Development of PDS0204 COVID-19 Vaccine
June 17 2020 - 08:30AM
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 a
co-development agreement with Farmacore Biotechnology for
Versamune®-CoV-2FC, a Versamune®-based vaccine aimed at preventing
COVID-19 infection.
Under the collaboration, PDS Biotech and
Farmacore will accelerate development of Versamune®-CoV-2FC into
Phase 1 clinical testing in Brazil, with initial financial support
provided by the Brazilian Ministry of Science, Technology,
Innovation and Communication (MCTIC). Versamune®-CoV-2FC combines a
Farmacore-developed recombinant SARS-CoV-2 protein with PDS
Biotech’s Versamune® platform nanotechnology. The rapid advancement
of this joint COVID-19 program expands upon a previously announced
research and development collaboration between PDS Biotech and
Farmacore to develop a Versamune®-based vaccine for
tuberculosis.
“We are excited to expand our ongoing
collaboration with Farmacore, which provides an opportunity to
rapidly accelerate development of a novel COVID-19 vaccine into
Phase 1 clinical testing in Brazil,” said Dr. Frank Bedu-Addo,
Chief Executive Officer, PDS Biotech. “We believe that pairing PDS
Biotech’s Versamune® T-cell activating vaccine technology with
Farmacore’s recombinant SARS-CoV-2 protein will allow us to quickly
assess the efficacy of Versamune®-CoV-2FC to potentially reduce the
continuing spread of COVID-19 infections.”
“This is a global pandemic, which requires a
global effort. In joining forces with our partner PDS Biotech, we
believe we can substantially accelerate our development efforts to
bring an effective COVID-19 vaccine, inducing a broader range of
long-term protective immune responses, to people around the world,”
said Helena Faccioli, Executive Director of Farmacore.
The companies plan to utilize multiple research
and development sites in the United States and Brazil to progress
preclinical and clinical development of Versamune®-CoV-2FC. Under
the terms of the agreement, Farmacore retains commercialization
rights in Latin America, and revenues from Latin America sales will
be shared between the two companies. PDS Biotech retains the right
of first refusal for commercialization outside of Latin America.
PDS Biotech is in discussions with other governmental and
non-governmental agencies regarding additional funding for a
COVID-19 vaccine.
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 Versamune®-CoV-2FC
Versamune®-CoV-2FC (PDS0204) is a COVID-19
vaccine candidate that combines the immune-activating Versamune®
platform with a Farmacore-developed recombinant fusion protein of
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
recognizable by our immune system (antigen). The vaccine’s target
profile is to provide rapid induction of neutralizing antibodies,
as well as killer T-cells and memory T-cells against the SARS-CoV-2
virus, in patients vaccinated with PDS0204 to protect against
COVID-19 and to prevent spread of the infection.
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 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
Tram Bui / Alexander LoboThe Ruth GroupPhone: +1
(646) 536-7035 / +1 (646) 536-7037Email: tbui@theruthgroup.com /
alobo@theruthgroup.com
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