TIDMNSCI
RNS Number : 2820J
NetScientific PLC
14 August 2023
RNS: For immediate release
NetScientific plc
PDS Biotechnology Announces Submission of Phase 3 Protocol to
FDA to Initiate VERSATILE-003 Trial
VERSATILE-003 will evaluate PDS0101 in combination with
KEYTRUDA(R) in recurrent or metastatic HPV16-positive head and neck
cancer
PDS Biotech anticipates initiating the VERSATILE-003 trial in
the fourth quarter of 2023
NetScientific Plc (AIM: NSCI), the deep tech and life sciences
VC investment group, reports that its portfolio company, PDS
Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage
immunotherapy company developing a growing pipeline of targeted
cancer immunotherapies and infectious disease vaccines based on its
proprietary T cell activating platforms, has announced the
submission to the U.S. Food and Drug Administration (FDA) of an
updated Chemistry, Manufacturing and Controls (CMC) package and a
Phase 3 multicenter registrational protocol to the company's
Investigational New Drug (IND) submission to evaluate the
combination of PDS0101 and KEYTRUDA(R) (pembrolizumab), Merck's
anti-PD-1 therapy, for the treatment of recurrent or metastatic
human papillomavirus (HPV) 16-positive head and neck squamous cell
carcinoma (HNSCC). The protocol was developed in accordance with
guidance from the FDA on key elements of the Phase 3 program to
support the eventual submission of a Biologics License Application
(BLA).
The Phase 3 trial, named VERSATILE-003, is a randomized, active
comparator-controlled study designed to investigate the safety and
efficacy of PDS0101 combined with KEYTRUDA(R) compared to
KEYTRUDA(R) monotherapy in immune checkpoint inhibitor (ICI)-naïve
patients with recurrent or metastatic HPV16-positive HNSCC. The
primary efficacy endpoint for VERSATILE-003, per the protocol, is
overall survival (OS). The Phase 3 study is expected to involve
approximately 90-100 clinical sites globally. PDS Biotech
anticipates initiating the VERSATILE-003 Phase 3 trial in the
fourth quarter of 2023.
Dr Ilian Iliev, CEO of NetScientific, commented:
" We congratulate PDS Biotech on reaching this significant
milestone and look forward to seeing the initiation in Q4 2023 of
this important Phase 3 trial, VERSATILE-003 ."
Dr Lauren V. Wood, PDS Biotech's Chief Medical Officer,
said:
" Submission of the protocol and supportive CMC documents for
this Phase 3 registrational trial is an important milestone for PDS
Biotech and our VERSATILE-003 program investigating PDS0101 in
combination with KEYTRUDA(R) as a potential treatment for recurrent
or metastatic HPV16-positive HNSCC. Interim data from our ongoing
VERSATILE-002 Phase 2 clinical trial have been very encouraging,
with impressive interim OS and PFS results. With VERSATILE-003, we
have an opportunity to confirm the Phase 2 results from
VERSATILE-002 in a controlled, Phase 3 clinical trial comparing the
combination of PDS0101 and KEYTRUDA(R) to KEYTRUDA(R)
monotherapy."
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/854-iotechnnouncesubmissionofhase3rotocolto20230814
-Ends-
For more information, please contact:
NetScientific
Ilian Iliev, CEO Via Belvedere Communications
WH Ireland (NOMAD, Financial Adviser and Broker)
Chris Fielding / Darshan Patel +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 a deep tech and life sciences
VC investment group with an international portfolio of innovative
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(R) 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 and
shrink tumours 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(R)
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.
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