TIDMNSCI
RNS Number : 8290U
NetScientific PLC
30 March 2023
RNS: For immediate release
NetScientific plc
("NetScientific" or the "Company")
PDS Biotech Announces Plan to Initiate Phase 3 Study Evaluating
PDS0101 in Combination with KEYTRUDA(R) in Head and Neck Cancer in
2023
Company has completed Phase 3 manufacturing of PDS0101 for
randomized, controlled, registrational trial in
recurrent/metastatic HPV16-positive head and neck cancer
NetScientific Plc (AIM: NSCI), the investment and
commercialisation group with an international portfolio of
innovative life science, sustainability and technology companies,
reports that its portfolio company, PDS Biotechnology Corporation
(Nasdaq: PDSB), a clinical-stage immunotherapy company developing a
growing pipeline of targeted immunotherapies for cancer and
infectious disease, today announced that it has completed key tech
transfer, scale up and manufacturing activities required to
initiate a global, multicenter Phase 3 registrational trial
investigating the combination of PDS0101 and KEYTRUDA(R)
(pembrolizumab), Merck's anti-PD-1 therapy, in the fourth quarter
of 2023.
The Phase 3 trial, named VERSATILE-003, will investigate the
combination compared to KEYTRUDA(R) monotherapy for the treatment
of unresectable, recurrent/metastatic human papillomavirus (HPV)
16-positive head and neck squamous cell carcinoma (HNSCC).
In preparation for the VERSATILE-003 trial, PDS Biotech plans to
submit an amended Investigational New Drug (IND) application to the
U.S. Food and Drug Administration (FDA) in the third quarter of
2023. VERSATILE-003 is expected to involve approximately 90-100
clinical sites globally.
PDS Biotech's plan to initiate the VERSATILE-003 trial follows
the successful completion of an End-of-Phase 2 meeting in the third
quarter of last year with the FDA, during which PDS Biotech
received guidance from the FDA on key elements of the Phase 3
program that will support the submission of a Biologics License
Application (BLA). Data reported at the 2022 American Society of
Clinical Oncology (ASCO) Annual Meeting indicated the combination
of PDS0101 and KEYTRUDA(R) achieved an objective response rate of
41% and an overall survival rate of 87% at nine months in 17
evaluable patients with HPV16 and PD-L1 positive recurrent or
metastatic HNSCC. Safety data reported on the first 43 patients
enrolled in the trial suggested that the combination was well
tolerated with no treatment-related Grade 3 or 4 Adverse Events.
Based on these data, the FDA granted Fast Track designation to the
combination of PDS0101 and KEYTRUDA for the treatment of
HPV16-positive HNSCC.
Dr. Frank Bedu-Addo, PDS Biotech CEO commented:
"With the maturing data from VERSATILE-002, we are pleased to
now have visibility into the progression free survival and
potential overall survival, and we are excited to move into the
final stage of development for our lead asset, PDS0101. The
initiation of a randomized, controlled Phase 3 registrational trial
of PDS0101 in combination with KEYTRUDA(R) as a potential treatment
for recurrent or metastatic HPV16-positive head and neck squamous
cell carcinoma is a significant milestone for the Company."
He added: "Head and neck cancer remains a devastating diagnosis
with a significant unmet medical need. Our goal is to advance this
Phase 3 trial as expeditiously as possible to provide additional
treatment options for these patients. We are proud to have achieved
this milestone on the eve of Oral, Head and Neck Cancer Awareness
Month."
Dr Ilian Iliev, CEO of NetScientific, said:
"NetScientific initiated its support for PDS when they were a
pre-clinical company, and it has been a privilege to watch how
Frank and his team have navigated the company to this important and
major milestone. We look forward to the launch of the Phase 3
trial, and the results of the rest of PDS' pipeline."
A full version of PDS Biotech's announcement can be accessed
here:
https://www.pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/125-2023-news/805-iotechnnounceslantonitiatehase3tudyvalua20230330
-Ends-
For more information, please contact:
NetScientific
Ilian Iliev, CEO Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel / Enzo Aliaj +44 (0)20 7220 1666
Belvedere Communications
John West / Llew Angus +44 (0) 203 008 6867
Email: nsci@belvederepr.com
About NetScientific
NetScientific plc (AIM: NSCI) is an investment and
commercialisation group with an international portfolio of
innovative life science, sustainability and technology
companies.
NetScientific identifies, invests in, and builds high growth
companies in the UK and internationally. The company adds value
through the proactive management of its portfolio, progressing to
key value inflection points, and delivering investment returns
through partial or full liquidity events.
NetScientific differentiates itself by employing a capital-light
investment approach, making judicial use of its balance sheet and
syndicating investments through its wholly owned VC subsidiary, EMV
Capital. The group secures a mixture of direct equity stakes and
carried interest stakes in its portfolio of companies, creating a
lean structure that can support a large portfolio.
NetScientific is headquartered in London, United Kingdom, and is
admitted to trading on AIM, a market operated by the London Stock
Exchange.
www.netscientific.net
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing
a growing pipeline of targeted cancer and infectious disease
immunotherapies based on our proprietary Versamune(R), Versamune(R)
plus PDS0301, and Infectimune(TM) T cell-activating platforms. We
believe our targeted immunotherapies have the potential to overcome
the limitations of current immunotherapy approaches through the
activation of the right type, quantity and potency of T cells. To
date, our lead Versamune(R) clinical candidate, PDS0101, has
demonstrated the ability to reduce tumors and stabilize disease in
combination with approved and investigational therapeutics in
patients with a broad range of HPV16-associated cancers in multiple
Phase 2 clinical trials. and will be advancing into a Phase 3
clinical trial in combination with KEYTRUDA(R) for the treatment of
recurrent/metastatic HPV16-positive head and neck cancer in 2023.
Our Infectimune(TM) based vaccines have also demonstrated the
potential to induce not only robust and durable neutralizing
antibody responses, but also powerful T cell responses, including
long-lasting memory T cell responses in pre-clinical studies to
date. To learn more, please visit www.pdsbiotech.com or follow us
on Twitter at @PDSBiotech.
About PDS0101
PDS0101, PDS Biotech's lead candidate, is a novel
investigational human papilloma virus (HPV)-targeted immunotherapy
that stimulates a potent targeted T cell attack against
HPV-positive cancers. PDS0101 is given by a simple subcutaneous
injection in combination with other immunotherapies and cancer
treatments. Interim data suggests PDS0101 generates clinically
effective immune responses, and the combination of PDS0101 with
other treatments can demonstrate significant disease control by
shrinking tumors, delaying disease progression and/or prolonging
survival. The combination of PDS0101 with other treatments does not
appear to compound the toxicity of other agents.
About VERSATILE-003
VERSATILE-003 is a randomized, controlled Phase 3 trial
evaluating the safety and efficacy of PDS0101, an HPV16-targeted
investigational T cell-activating immunotherapy that leverages PDS
Biotech's proprietary Versamune(R) technology, in combination with
Merck's anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab) compared to
KEYTRUDA(R) monotherapy. The combination is being evaluated in
immune checkpoint inhibitor (ICI)-naïve patients with
recurrent/metastatic HPV16-positive head and neck squamous cell
carcinoma (HNSCC) and was granted Fast Track designation by the
Food and Drug Administration in June 2022.
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