TIDMNSCI
RNS Number : 8655E
NetScientific PLC
10 November 2020
NetScientific plc
("NetScientific" or the "Company")
PDS Biotech Initiates VERSATILE-002 Phase 2 Combination Trial of
PDS0101-KEYTRUDA(R) in Recurrent/Metastatic Head and Neck Cancer in
Collaboration with Merck
VERSATILE-002 Trial for First Line Treatment of
Recurrent/Metastatic Head and Neck Cancer with Combination
PDS0101-KEYTRUDA(R) is Now Open and Recruiting Patients
London, UK - 10 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) today announced that its
VERSATILE-002 Phase 2 clinical trial evaluating the combination of
PDS0101 and KEYTRUDA(R) (pembrolizumab) for the first-line
treatment of head and neck cancer that has returned or spread, is
now open. The trial is being conducted in collaboration with
Merck.
The VERSATILE-002 Phase 2 trial is a multi-center, open label,
single arm, non-randomised trial that plans to enroll approximately
100 patients across 25 sites in the United States of America. The
University of Tennessee Medical Center is the first site to open.
The studies performed at the UT Medical Center will be led by
Principal Investigator Dr. Timothy Panella, M.D. The clinical study
will evaluate the efficacy and safety of PDS0101, PDS Biotech's
lead Versamune(R)-based immunotherapy targeting human
papillomavirus (HPV)-associated cancers, in combination with
KEYTRUDA(R) (pembrolizumab), Merck's checkpoint inhibitor, in the
first-line treatment of patients with HPV16-positive head and neck
cancer that has returned or spread. KEYTRUDA(R) was approved by the
FDA in June 2019 as first-line treatment for recurrent or
metastatic head and neck cancer. VERSATILE-002 will study if
combining PDS0101 with KEYTRUDA(R) is more effective than what has
been previously shown with KEYTRUDA(R) alone. The main efficacy
endpoint in this study is shrinkage of the tumor referred to as the
objective response rate (ORR) at nine months following the
initiation of treatment with the combination.
"The launch of the VERSATILE-002 Phase 2 trial demonstrates our
commitment to developing a safe and effective treatment option that
builds upon the current standard of care for patients with this
aggressive cancer and further strengthens our collaboration with
Merck," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Though
the COVID-19 pandemic impacted our initial timeline, we are pleased
to open up this trial to patients."
Dr. Ilian Iliev, Chief Executive Office of the Company and
Director of PDS Biotechnology said: "We are pleased at the
continued and accelerating progress of PDS in reaching this key
milestone with the start of this Phase 2 combination trial. The
collaboration with Merck for this trial is another significant step
forward for the company. The trial will determine if the
combination provides improved treatment benefit to patients when
compared with administration of Merck's KEYTRUDA(R) first-line
treatment only. This further progress follows the development plans
presented earlier this year by PDS to NetScientific."
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://pdsbiotech.com/investors/news-center/press-releases/press-releases1/56-2020-news/451-iotechnitiates002hase2ombinationri20201109
# # #
PDS Biotech Initiates VERSATILE-002 Phase 2 Combination Trial of
PDS0101-KEYTRUDA(R) in Recurrent/Metastatic Head and Neck Cancer in
Collaboration with Merck
VERSATILE-002 Trial for First Line Treatment of
Recurrent/Metastatic Head and Neck Cancer with Combination
PDS0101-KEYTRUDA(R) is Now Open and Recruiting Patients
Florham Park, NJ, November 9, 2020 - PDS Biotechnology
Corporation (Nasdaq: PDSB), a clinical-stage immuno-oncology
company developing novel cancer therapies and infectious disease
vaccines based on the Company's proprietary Versamune(R) T-cell
activating technology, today announced that its VERSATILE-002 Phase
2 clinical trial evaluating the combination of PDS0101 and
KEYTRUDA(R) (pembrolizumab) for the first-line treatment of head
and neck cancer that has returned or spread is now open. The trial
is being conducted in collaboration with Merck.
The VERSATILE-002 Phase 2 trial is a multi-center, open label,
single arm, non-randomized trial that plans to enroll approximately
100 patients across 25 sites in the U.S.. The University of
Tennessee Medical Center is the first site to open. The studies to
be performed at the UT Medical Center will be led by Principal
Investigator Dr. Timothy Panella, M.D. The clinical study will
evaluate the efficacy and safety of PDS0101, PDS Biotech's lead
Versamune(R)-based immunotherapy targeting human papillomavirus
(HPV)-associated cancers, in combination with KEYTRUDA(R)
(pembrolizumab), Merck's checkpoint inhibitor, in the first-line
treatment of patients with HPV16-positive head and neck cancer that
has returned or spread. KEYTRUDA(R) was approved by the FDA in June
2019 as first-line treatment for recurrent or metastatic head and
neck cancer. VERSATILE-002 will study if combining PDS0101 with
KEYTRUDA(R) is more effective than what has been previously shown
with KEYTRUDA(R) alone. The main efficacy endpoint in this study is
shrinkage of the tumor referred to as the objective response rate
(ORR) at nine months following the initiation of treatment with the
combination.
"The launch of the VERSATILE-002 Phase 2 trial demonstrates our
commitment to developing a safe and effective treatment option that
builds upon the current standard of care for patients with this
aggressive cancer and further strengthens our collaboration with
Merck," commented Dr. Frank Bedu-Addo, CEO of PDS Biotech. "Though
the COVID-19 pandemic impacted our initial timeline, we are pleased
to open up this trial to patients."
Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech added,
"Initial studies suggest that Versamune(R)-based immunotherapies
administered in combination with checkpoint inhibitors, such as
KEYTRUDA(R), have the potential to enhance the immune system's
ability to induce a more powerful and targeted anti-tumor response.
We look forward to sharing updates as this study progresses."
"We are thrilled to offer our patients with recurrent or
metastatic head and neck cancer such an exciting and potentially
safe treatment option," commented Dr. Timothy Panella, who is the
VERSATILE-002 Principal Investigator at the UT Medical Center,
"this type of combination approach is attractive to patients and
offers a novel targeted therapy in the fight against this very
challenging disease."
Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck
Oncology at the University of Carolina at Chapel Hill School of
Medicine and Lineberger Comprehensive Cancer Center, is serving as
the Lead Principal Investigator of VERSATILE-002. Patients
interested in enrolling in this clinical study should email
info@pdsbiotech.com or visit the website at
http://pdsbiotech.com/VERSATILE-002 to learn more.
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 and 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 separate partnership with the National Cancer
Institute (NCI), and The University of Texas MD Anderson Cancer
Center, PDS Biotech is conducting additional Phase 2 studies in
advanced HPV-associated cancers and advanced localized cervical
cancer respectively.
# # #
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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