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, and Farmacore
Biotechnology today announced that Blanver Farmoquímica e
Farmacêutica S.A. has joined their consortium to develop and
commercialize a novel COVID-19 vaccine in Latin America.
Blanver is a leading Brazilian Pharmaceutical
Company focused on the development, manufacture, and
commercialization of innovative pharmaceutical products. Under the
terms of the agreement, São Paulo-based Blanver will manufacture,
promote, distribute, and commercialize the Versamune®-based
COVID-19 vaccine in Latin America. As the license holder of
Versamune-CoV2-FC (PDS0203) in Latin America, Farmacore will
continue to lead the regulatory and clinical trial efforts in
Brazil and has selected a top clinical research organization to
conduct clinical trials in Brazil. PDS Biotech will continue to
contribute scientific expertise and operational support.
“Innovation is part of Blanver’s DNA,” commented
Sergio Frangioni, Blanver Group CEO. “We are honored to join the
consortium with PDS Biotech and Farmacore as our partners in Latin
America to advance this innovative treatment to patients quickly in
the fight against this deadly disease.”
“We are delighted to have these two expert
partners in Latin America, who provide a combination of scientific
and manufacturing expertise in addition to local market experience
to help broaden the potential reach of a Versamune®-based COVID-19
vaccine to patients,” said Dr. Frank Bedu-Addo, CEO of PDS
Biotech.
“We are excited to add Blanver’s wealth of
experience in development and commercialization across Latin
America to this consortium as we continue in the fight against this
global pandemic,” said Helena Faccioli, CEO of Farmacore.
The consortium is in active discussions with
specific agencies of the Brazilian government to extend the
preclinical funding to cover the upcoming human clinical trials
anticipated to begin during the first half of 2021.
The novel vaccine combines PDS Biotech’s
Versamune® T-cell activating technology with a SARS-CoV-2
recombinant protein antigen co-developed with Farmacore. As
previously disclosed, preclinical data demonstrated that the
vaccine 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 antigen without Versamune®. The study
also demonstrated induction of long-lasting virus-specific memory
T-cells necessary for longer term protection. The studies also
demonstrated strong, long-lasting induction of neutralizing
antibodies. Notably, the vaccine contains a protein derived from
the spike (S) protein that also includes the receptor binding
domain (RBD) as well as other potentially non-mutating regions of
the virus that can be recognized and attacked by T-cells. The
vaccine is based on recombinant proteins (subunit vaccine) and does
not require the use of attenuated viruses, traditional adjuvants,
DNA or RNA to induce robust protective immune responses. In
addition, a recent Phase I study of PDS0101, a Versamune®-based
HPV16 subunit vaccine, demonstrated powerful T-cell responses and
an attractive human safety profile with no serious or dose-limiting
toxicities, presenting strong potential for an attractive safety
profile for the novel Versamune®-based SARS-CoV-2 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
Biotechnology
Farmacore Biotechnology 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 Blanver Farmoquímica
Blanver Farmoquímica e Farmacêutica S.A. is a
Brazilian company, founded in 1984, focused on R&D, manufacture
and sale of innovative medicines and active pharmaceutical
ingredients (APIs). The company plays in the segments of HIV,
Hepatitis, Oncology and Hematology, providing high quality products
for expanding the population's access to medicines through
partnerships with the Ministry of Health and official laboratories.
Blanver is committed in always looking for innovations that will
improve people's health and quality of life.
About
Versamune-CoV-2FC/PDS0203
PDS0203 is an investigational vaccine designed
for the prevention of COVID-19 being developed for Latin America by
a consortium that includes PDS Biotech, Farmacore Biotechnology and
Blanver Farmoquímica. The vaccine 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
polyfunctional CD8+ killer and CD4+ helper 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 RandolphPDS BiotechPhone: +1 (908)
517-3613Email: drandolph@pdsbiotech.com
Jacob GoldbergerCG CapitalPhone: +1 (404)
736-3841Email: jacob@cg.capital
PDS Biotechnology (NASDAQ:PDSB)
Historical Stock Chart
From Mar 2024 to Apr 2024
PDS Biotechnology (NASDAQ:PDSB)
Historical Stock Chart
From Apr 2023 to Apr 2024