TIDMNSCI
RNS Number : 0210F
NetScientific PLC
11 November 2020
NetScientific plc
("NetScientific" or the "Company")
PDS Biotech and Farmacore Announce Updates to Co-Development of
Versamune(R)-Based COVID-19 Vaccine
PDS0203 prioritized for clinical development by PDS Biotech and
Farmacore after successful meeting with Brazilian Drug Regulatory
Agency
London, UK - 11 November 2020 - NetScientific plc (AIM: NSCI),
the life sciences, technology investment and commercialisation
company, announces that its portfolio company PDS Biotechnology
Corporation ("PDS") (Nasdaq: PDSB) announced progress on its
co-development program with Farmacore Biotechnology for a
Versamune(R)-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(R)-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.
"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(R)-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(R)-based vaccines like PDS0203 to
provide long-term protection against infection with viruses such as
SARS-CoV-2."
NetScientific holds approximately 5.75% of PDS' undiluted share
capital.
The full details of the announcement are set out below and can
be found he re:
https://www.pdsbiotech.com/investors/news-center/press-releases/press-releases1/56-2020-news/454-iotechandarmacorennouncepdatestooevelopmen20201110
# # #
PDS Biotech and Farmacore Announce Updates to Co-Development of
Versamune(R)-Based COVID-19 Vaccine
PDS0203 prioritized for clinical development by PDS Biotech and
Farmacore after successful meeting with Brazilian Drug Regulatory
Agency
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(R) T-cell activating technology, today announced progress
on its co-development program with Farmacore Biotechnology for a
Versamune(R)-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(R)-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(R). 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(R)-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(R)-based vaccines like PDS0203 to
provide long-term protection against infection with viruses such as
SARS-CoV-2."
"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(R) T-cell
activating technology platform. Versamune(R) 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(R) 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(R) platform with a recombinant native Severe Acute
Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein
recognizable by our immune system (antigen). The Versamune(R)
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 .
# # #
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulations (EU) No. 596/2014. Following the
publication of this announcement, this inside information is now
considered to be in the public domain.
For more information, please contact:
NetScientific
Ilian Iliev, CEO Tel: +44 (0)20 3514 1800
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel Tel: +44 (0)20 7220 1666
About NetScientific
NetScientific is a life sciences, technology investment and
commercialisation Group, leveraging trans-Atlantic relationships
and global opportunities to deliver shareholder value.
For more information, please visit the website at www.NetScientific.net
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