REG - NetScientific PLC - PDS Biotech: Submission of Phase 3 Protocol to FDA

NetscientificAnnouncement

14/08/2023 18:00

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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(®) 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(®) (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(®) compared to KEYTRUDA(®) 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(®) 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(®) to KEYTRUDA(®) 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
(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 (mailto: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 (http://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(®), Versamune(®) plus PDS0301, and
Infectimune(®) 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(®) 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(®) for the treatment of
recurrent/metastatic HPV16-positive head and neck cancer in 2023. Our
Infectimune(®) 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
(http://www.pdsbiotech.com) or follow us on Twitter at @PDSBiotech.

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