TIDMNSCI
RNS Number : 7069O
NetScientific PLC
03 October 2019
NetScientific plc
("NetScientific" or the "Company")
Portfolio Company PDS Biotechnology collaborates with Merck in
Phase 2 studies for PDS0101 in metastatic head and neck cancer and
high-risk human papillomavirus-16 (HPV16) infection
London, UK - 03 October 2019 - NetScientific plc (AIM: NSCI),
the transatlantic healthcare IP commercialisation Group, is pleased
to note the modification to the collaboration of its portfolio
company, PDS Biotechnology ("PDS") (Nasdaq: PDSB), with Merck in a
Phase II clinical study of their lead product, PDS0101 in
combination with Merck's anti-PD-1 therapy, KEYTRUDA(R)
(pembrolizumab), as a first line treatment in patients with
recurrent or metastatic head and neck cancer and high-risk human
papillomavirus-16 (HPV16) infection.
The planned clinical trial will now evaluate the efficacy and
safety of the combination as a first-line treatment in patients
with recurrent or metastatic head and neck cancer and high-risk
human papillomavirus-16 (HPV16) infection and is expected to be
initiated in the first quarter of 2020.
Full details are set our below.
Ian Postlethwaite, CEO of NetScientific, said:
"This collaboration advancing PDS0101 into Phase II studies
clearly demonstrates the strength of the results from PDS's initial
Phase I studies for PDS0101. Merck is renowned in the field of
immuno-oncology, and PDS0101 when working in combination with their
leading treatment for cancer, KEYTRUDA(R), has the potential to
offer a new and exciting therapy for patients suffering from these
devastating diseases."
# # #
Below is the full announcement made today by PDS
Biotechnology:
PDS Biotechnology Corp. Announces Clinical Collaboration with
Merck
PDS0101- KEYTRUDA(R) (Pembrolizumab) Combination to be Evaluated
in First Line Treatment of Metastatic Head and Neck Cancer
Berkeley Heights, NJ, October 03, 2019 / PDS Biotechnology
Corporation ("PDS Biotechnology") (Nasdaq: PDSB), a clinical-stage
immuno-oncology company pioneering the development of
multi-functional immunotherapeutic products, today announced a
modification of the clinical trial collaboration agreement with a
subsidiary of Merck (known as MSD outside the United States and
Canada) to evaluate the combination of PDS's lead Versamune(R)
-based immunotherapy, PDS0101, with Merck's anti-PD-1 therapy,
KEYTRUDA(R) (pembrolizumab), in a Phase II clinical trial. The
planned clinical trial will now evaluate the efficacy and safety of
the combination as a first-line treatment in patients with
recurrent or metastatic head and neck cancer and high-risk human
papillomavirus-16 (HPV16) infection and is expected to be initiated
in the first quarter of 2020.
The modification to the clinical trial design now allowing
evaluation of PDS0101 in combination with KEYTRUDA(R) as first-line
treatment comes as a result of Merck's recent approval by the FDA
on June 10, 2019 for KEYTRUDA(R) as monotherapy in patients whose
tumors express PD-L1 (CPS >=1) or in combination with platinum
and fluorouracil (FU) for the first-line treatment of patients with
metastatic or with unresectable, recurrent head and neck squamous
cell carcinoma.
"We are honored to collaborate with Merck, a proven leader in
the field of immuno-oncology to evaluate novel investigational
combination therapies that have the potential to further improve
the lives of cancer patients," said Dr. Lauren V. Wood, Chief
Medical Officer of PDS." The recently updated clinical outcome
findings of the PDS0101 phase 1 human clinical trial demonstrate
unique in-vivo systemic induction of high levels of granzyme-b
inducing HPV-specific killer T-cells associated with observed
clinical responses (regression/ elimination of pre-cancerous
lesions) in the majority of evaluable patients treated with PDS0101
monotherapy, and a lack of dose limiting toxicities at all tested
doses (PDS press release September 19, 2019). Preclinical data
demonstrating the novel multi-functional mechanism of action of the
Versamune(R) platform technology and the resulting superior T-cell
induction and unique regression of advanced tumors were published
in the June 2019 issue of the Journal of Immunology.
PDS Biotechnology's lead product candidate, PDS0101
(Versamune(R)-HPV) is a proprietary clinical stage
immunotherapeutic administered by subcutaneous injection being
developed to treat HPV-associated cancers. These include cancers
such as head and neck cancers and anal cancers, both of which are
widely reported to be increasing in frequency over the last decade,
and cervical cancer.
Details of the collaboration were not disclosed.
KEYTRUDA(R) is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
Versamune(R) is a registered trademark of PDS Biotechnology
Corporation, Berkeley Heights, NJ, USA.
About the Versamune(R) Platform Technology
Versamune(R) is a proprietary, synthetic lipid-based T-cell
activating platform. PDS Biotechnology's pipeline of
Versamune(R)-based products, which are administered by subcutaneous
injection, provides strong activation of type I interferon genes.
The Versamune(R) mechanism of action also involves effective
presentation of tumor antigens via the MHC Class I and Class II
pathways. These mechanisms together promote strong in-vivo
induction of polyfunctional tumor-targeting CD8+ T-cells.
Versamune(R)-based immunotherapies have been demonstrated to alter
the tumor micro-environment in preclinical mechanism of action
studies, thus further enhancing the ability of Versamune(R)-induced
T-cells to effectively kill tumor cells. Preclinical data
demonstrating the novel multi-functional mechanism of action of the
Versamune(R) platform technology and the resulting superior T-cell
induction and unique regression of advanced tumors were published
in the Journal of Immunology (Journal of Immunology, Vol. 202,
Issue 1215 June 2019).
About PDS Biotechnology and PDS0101
PDS Biotechnology is a clinical stage immuno-oncology company
with a growing pipeline of clinical-stage immunotherapies to treat
various HPV-associated cancers, including head and neck cancer,
cervical and anal cancers. PDS0101 includes the Versamune(R)
immune-activating platform and a mixture of HPV16 E6 and E7 peptide
antigens designed to induce cytolytic T-cell responses against HPV
expressed in patients with HPV-associated cancers. Clinical outcome
findings from the PDS0101 Phase 1 clinical study demonstrated
unique in-vivo systemic induction of high levels of granzyme-b
inducing HPV-specific killer T-cells associated with observed
clinical responses (regression and elimination of pre-cancerous
lesions) in the majority of evaluable patients treated with PDS0101
monotherapy, and a lack of dose limiting toxicities at all tested
doses.
For full release and additional information about PDS, please
visit www.pdsbiotech.com.
# # #
This announcement contains inside information for the purposes
of Article 7 of the Market Abuse Regulation (EU) No. 596/2014.
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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