NetScientific PLC PDS Initiates Programs for COVID-19, PDS0101 delay
16 Abril 2020 - 10:02AM
RNS Non-Regulatory
TIDMNSCI
NetScientific PLC
16 April 2020
NetScientific plc
("NetScientific" or the "Company")
PDS Biotechnology Initiates Novel Vaccine Development Programs
For COVID-19
and Universal Influenza; Delay of PDS0101 VERSATILE-002
trial
London, UK - 16 April 2020 - NetScientific plc (AIM: NSCI), the
transatlantic healthcare IP commercialisation Group, today
announces that its portfolio company PDS Biotechnology Corporation
("PDS") (Nasdaq: PDSB) announced today an expanded infectious
disease pandemic development program, including novel vaccines for
COVID-19 and universal influenza, in addition to its previously
announced tuberculosis development collaboration with Farmacore
Biotechnology. The Company also announced that initiation of its
multi-center Phase 2 VERSATILE-002 trial for PDS0101 in
advanced/metastatic head and neck cancer has been delayed due to
the severe adverse impact on clinical trial operations from the
COVID-19 pandemic.
Below is the full announcement made today by PDS
Biotechnology
# # #
PDS Biotechnology Initiates Novel Vaccine Development Programs
For COVID-19 and Universal Influenza; Delay of PDS0101
VERSATILE-002 trial
Expanded infectious disease program to address current and
potential pandemics builds on existing tuberculosis
collaboration
Initiation of Phase 2 VERSATILE-002 trial for PDS0101 in
advanced/metastatic head and neck cancer delayed due to global
COVID-19 pandemic
PRINCETON, N.J., April 16, 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 an
expanded infectious disease pandemic development program, including
novel vaccines for COVID-19 and universal influenza, in addition to
its previously announced tuberculosis development collaboration
with Farmacore Biotechnology. The Company also announced that
initiation of its multi-center Phase 2 VERSATILE-002 trial for
PDS0101 in advanced/metastatic head and neck cancer has been
delayed due to the severe adverse impact on clinical trial
operations from the COVID-19 pandemic.
PDS Biotech's products combine its novel Versamune(R) technology
with custom-designed, disease-specific proteins to induce both
neutralizing antibody and killer (CD8+) T-cell responses, which
when co-induced are more powerful in fighting disease than either
alone. This proven Versamune(R) mechanism, combined with a
favorable safety profile, provides a strong rationale to expand the
development of Versamune(R)-based products beyond its initial
series of cancer immunotherapies to add potentially transformative
vaccines to protect and fight against infectious agents, including
COVID-19, influenza, and tuberculosis.
In the Company's previously reported Phase I clinical study of
PDS0101 (NCT02065973), Versamune(R) was confirmed to be safe and to
uniquely facilitate the induction of strong antigen-specific CD8+
and CD4+ T-cells in vivo, including memory T-cell responses against
the HPV viral target, leading to regression of disease.
"The potency and versatility of the proprietary Versamune(R)
T-cell activating platform makes it possible for PDS Biotech to
immediately start development of novel vaccines to protect against
infectious disease agents with pandemic potential, starting with
COVID-19 and influenza," commented Dr. Frank Bedu-Addo, CEO of PDS
Biotech. "Preventive vaccines to date have focused on induction of
neutralizing antibodies. However, both neutralizing antibodies and
killer (CD8+) T-cells have now been confirmed to be important in
addressing pathogen-induced diseases such as COVID-19, influenza
and tuberculosis. We believe that there is a clear opportunity to
leverage our Versamune(R) platform to develop more effective
vaccines that have the potential to safely generate a broader range
of immune responses, including antibodies, killer T-cells, and
memory T-cells, to prevent and to provide long-term protection
against the spread of pandemic agents."
"While we are adding these new programs, we remain committed to
our immuno-oncology programs, including two upcoming single-site
Phase 2 studies - one with the NCI to evaluate PDS0101 in
combination with two promising immuno-modulating agents in advanced
HPVassociated cancers, and another to evaluate the combination of
PDS0101 and chemoradiation in patients with locally advanced
cervical cancer. We will continue to closely monitor the impact of
COVID-19 on these trials and on oncology clinical trial operations
in the US, and will seek to initiate our Phase 2 head and neck
cancer trial in the near future if possible," Dr. Bedu-Addo
concluded.
Dr. Lauren Wood, Chief Medical Officer of PDS Biotech added,
"Versamune(R) has demonstrated a superior ability to present viral
antigens to our immune system, while simultaneously activating
critical immunological pathways that enable the immune system to
more effectively respond to and protect against disease. The
engineered simplicity, ease of administration, and scalability of
Versamune(R) also enhances the potential of Versamune(R)-based
products to better mitigate the devastating impact of emerging
pathogens such as coronaviruses on human health. As we seek to
advance our expanded infectious disease development effort, we look
forward to discussions with relevant government and
non-governmental organizations to determine the most expeditious
path forward into human testing."
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
diseasespecific 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.
For more information, please contact:
NetScientific Tel: +44 (0)20 3514 1800
Ian Postlethwaite, CEO/CFO
WHIreland (NOMAD, Financial Adviser Tel: +44 (0)20 7220 1666
and Broker)
Chris Fielding / Darshan Patel
MO PR ADVISORY (Press Contact) Tel: +44 (0)78 7644 4977
Mo Noonan
About NetScientific
NetScientific PLC is a transatlantic healthcare IP
commercialisation Group focused on technologies and companies that
have the potential to treat chronic disease and significantly
improve the health and well-being of people.
For more information, please visit the website at www.NetScientific.net
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END
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