TIDMNSCI
RNS Number : 0019Q
NetScientific PLC
15 June 2020
NetScientific plc
("NetScientific" or the "Company")
PDS Biotech Announces Initiation of Phase 2 Trial of PDS0101 Led
by the National Cancer Institute
NetScientific plc (AIM:NSCI), the transatlantic healthcare IP
commercialisation group, announces that its portfolio company PDS
Biotechnology Corporation ("PDS") (Nasdaq: PDSB) today announced
that the first patient has been dosed in the National Cancer
Institute's (NCI) Phase 2 clinical study of PDS0101 in the
treatment of advanced human papillomavirus (HPV) associated
cancers. This clinical trial involves a combination of PDS0101 with
two clinical development-stage immune-modulating agents, Bintrafusp
alfa (M7824) and NHS-IL12.
NetScientific holds 7.18% of PDS' undiluted share capital.
The full details of the announcement are set out below and can
be found here:
https://www.pdsbiotech.com/investors/news-center/press-releases/press-releases1/56-2020-news/394-iotechnnouncesnitiationofhase2rialof01020200615
# # #
FLORHAM PARK, N.J., June 15, 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 that the
first patient has been dosed in the National Cancer Institute's
(NCI) Phase 2 clinical study of PDS0101 in the treatment of
advanced human papillomavirus (HPV) associated cancers. This
clinical trial involves a combination of PDS0101 with two clinical
development-stage immune-modulating agents, Bintrafusp alfa (M7824)
and NHS-IL12.
The NCI Center for Cancer Research's Genitourinary Malignancies
Branch (GMB) and Laboratory of Tumor Immunology and Biology (LTIB)
are jointly leading this Phase 2 trial evaluating PDS0101, which
combines the Versamune(R) platform with targeted antigens in
HPV-expressing cancers, in combination with Bintrafusp alfa (M7824)
and NHS-IL12.
The trial will evaluate the objective response rate of this
novel triple combination in approximately 35 patients with advanced
HPV-associated cancers. The first eight patients will be evaluated
for safety and objective response before the trial progresses to
full enrollment.
"We are excited to have the first patient dosed in this NCI-led
Phase 2 clinical trial, which is an important next step in further
demonstrating the power of our novel Versamune(R) platform to
induce high levels of tumor-specific CD8 killer T-cells," commented
Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. "We believe
that PDS0101's demonstrated preclinical efficacy when combined with
these two immune-modulating agents, has the potential to
significantly improve clinical outcomes for patients with advanced
HPV-associated cancers."
Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief,
GMB, at NCI are serving as principal investigators for the NCI,
while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech's Chief
Executive Officer and Chief Medical Officer respectively, will
serve as PDS Biotech's investigators. The studies are being
performed as part of a Cooperative Research and Development
Agreement (CRADA) between PDS Biotech and the NCI.
Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the
principal investigator of this phase 2 clinical trial of PDS0101 in
advanced HPV-associated cancers. For patients interested in
enrolling in this clinical study, please call NCI's toll-free
number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email
NCIMO_Referrals@mail.nih.gov, and/or visit the website:
https://trials.cancer.gov.
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 PDS0101
PDS Biotech's lead candidate, PDS0101, combines the utility of
the Versamune(R) platform with targeted antigens in HPV-expressing
cancers. In partnership with Merck & Co., PDS Biotech is
advancing a combination of PDS0101 and KEYTRUDA(R) to a Phase 2
study in first line treatment of recurrent or metastatic head and
neck cancer. In partnership with the National Cancer Institute
(NCI), PDS Biotech is also advancing a combination of PDS0101 and
two clinical stage immunotherapies to a Phase 2 study in advanced
HPV-associated cancers. A third phase 2 study is to be performed in
advanced localized cervical cancer combining PDS0101 with standard
of care chemoradiotherapy.
# # #
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
MO PR ADVISORY (Press Contact)
Mo Noonan Tel: +44 (0)78 7644 4977
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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