REG - EMV Capital PLC - PDS: VERSATILE-003 Phase 3 Clinical Trial

EMV CapitalAnnouncement

07/03/2025 16:30

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250307:nRSG8848Za&default-theme=true

RNS Number : 8848Z  EMV Capital PLC  07 March 2025

For immediate release

 

EMV Capital plc

 

("EMVC" or the "Company")

 

PDS Biotech Initiates VERSATILE-003 Phase 3 Clinical Trial Evaluating
Versamune® HPV in HPV16-Positive Head and Neck Cancer

 

First-ever HPV16-positive head and neck cancer Phase 3 clinical trial

 

EMV Capital plc (AIM: EMVC), the deeptech and life sciences VC investment
group, reports that its portfolio company PDS Biotechnology Corporation
(Nasdaq: PDSB) - a late-stage immunotherapy company focused on transforming
how the immune system targets and kills cancers, and in which it holds a 2.3%
direct holding - has announced the initiation of the VERSATILE-003 Phase 3
clinical trial. The trial is now open to patient enrollment.

 

Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech,
said:

 

"We are thrilled to share that the first trial site has been initiated, and
activation of additional clinical sites continues. Considering the strength
and durability of the clinical responses in our VERSATILE-002 study, we are
pleased to get this registrational trial underway. We are confident in the
potential of our innovative combination therapy to improve patient outcomes
and enhance the standard of care."

 

VERSATILE-003 is a global, multi-centre, randomized, controlled and open-label
Phase 3 pivotal trial designed to evaluate the safety and efficacy of
Versamune(®) HPV in combination with pembrolizumab as a first-line treatment
for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma
("HNSCC"). The trial is designed to enroll approximately 350 patients into
either the investigational arm or into a control arm receiving pembrolizumab
alone at a 2:1 ratio. The primary endpoint is overall survival, and secondary
endpoints include objective response rate, progression free survival, disease
control rate and duration of response. Katharine Price, M.D., Associate
Professor of Oncology, Head and Neck Disease Group, Mayo Clinic Comprehensive
Cancer Centre will serve as the trial's Principal Investigator.

 

Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, said:

 

"Advancing into Phase 3 is a significant milestone in our mission to improve
treatment options for patients with HPV16-positive recurrent/metastatic HNSCC,
and we are optimistic about the potential of Versamune(®) HPV in combination
with pembrolizumab to enhance immune response and deliver meaningful clinical
benefits."

 

Versamune(®) HPV is an HPV-specific T cell stimulating immunotherapy
delivered subcutaneously that has shown the potential to stimulate high levels
of HPV16-specific CD8+ and CD4+ T cells within patients by activating multiple
immune pathways. Based on data from the VERSATILE-002
(https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Flinkprotect.cudasvc.com%2Furl%3Fa%3Dhttps%253a%252f%252fpdsbiotech.us4.list-manage.com%252ftrack%252fclick%253fu%253d407bd594246e0ad6fd93882af%2526id%253daf818bcfe2%2526e%253d27d88613f0%26c%3DE%2C1%2CDqgtT033Iftgqwp-MJSMKuoQN-mQWlpq1FmFV1NjJEvmC2uyaVH-uxxZ-v8cpj9QNMb9Uh3OBKt2ZWEhkrJ8zjlTnXVncfeDMcX8cE93lJSc3ruUNRPGMAvLyy4%2C%26typo%3D1&data=05%7C02%7Clangus%40rosewoodpr.co.uk%7Ca249c6512c3f4f372f7808dd5d85014a%7Cb9b2cf7e777c4d0caf8dae122314ff67%7C0%7C0%7C638769548052545021%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=IMBY2Df0B2PF9CI65xNCX4O3qAOgL%2B4p7FMjFqQsl20%3D&reserved=0)
Phase 2, open-label, multicenter trial, the U.S. Food and Drug Administration
granted Versamune(®) HPV Fast Track designation, making it eligible for
Priority Review at the time of Biologics License Application (BLA) submission.

 

For more information on VERSATILE-003, visit ClinicalTrials.gov
(https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Flinkprotect.cudasvc.com%2Furl%3Fa%3Dhttps%253a%252f%252fClinicalTrials.gov%26c%3DE%2C1%2Ceon8ilRRdAqwDKBZmSlmfBd3-pEXpyZUWDb_lCiA8qiy_awVdnWyx3YCsuopxJt-M22lD_o2YSTIx0cszhi-HQXAi-I8l15Iv0PKCSiC%26typo%3D1%26ancr_add%3D1&data=05%7C02%7Clangus%40rosewoodpr.co.uk%7Ca249c6512c3f4f372f7808dd5d85014a%7Cb9b2cf7e777c4d0caf8dae122314ff67%7C0%7C0%7C638769548052564702%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ANSRR4poRklLpaXxuhORfRfjzWSSP09eCt7Qhhr5peE%3D&reserved=0)
(Identifier: NCT06790966
(https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Flinkprotect.cudasvc.com%2Furl%3Fa%3Dhttps%253a%252f%252fpdsbiotech.us4.list-manage.com%252ftrack%252fclick%253fu%253d407bd594246e0ad6fd93882af%2526id%253da75d21f283%2526e%253d27d88613f0%26c%3DE%2C1%2Chk1aXwIP4Y6UpEJ161SDX5NpHcuKmnjK3o_qfzOCVWNrvxIWaVqYF_w68z2BgIZ40HReUVyPKyfGoLj6dMbKJcLmorHKHjYoZoR1tOs1qw%2C%2C%26typo%3D1&data=05%7C02%7Clangus%40rosewoodpr.co.uk%7Ca249c6512c3f4f372f7808dd5d85014a%7Cb9b2cf7e777c4d0caf8dae122314ff67%7C0%7C0%7C638769548052582874%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Rs%2BY00bV70wlaytRtCBCKhxkogxjQrQvSOxSxaOWNe4%3D&reserved=0)
).

 

A full version of PDS Biotech's announcement can be accessed here:

 

https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/132-2025-news/973-iotechnitiates003hase3linicalrial20250307
(https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/132-2025-news/973-iotechnitiates003hase3linicalrial20250307)
(https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/132-2025-news/972-iotechnnouncesupto22illionegisteredirect20250227)
 

 

-Ends-

 

For more information, please contact:

 EMV Capital plc                                                              via Rosewood

 Ilian Iliev, CEO

 Panmure Liberum (UK) Limited (NOMAD and Broker)                              +44 (0)20 7886 2500

 Emma Earl / Will Goode / Freddy Crossley / Mark Rogers (Corporate Finance)

 Rupert Dearden (Corporate Broking)

 Rosewood (Financial PR)                                                      +44 (0)20 7653 8702
 John West / Llewellyn Angus / Lily Pearce

 

 

About EMV Capital plc (EMVC)

 

EMV Capital plc, formerly known as NetScientific plc, is a deep tech and life
sciences venture capital investment group with an international portfolio of
high-growth companies.

With a strategic focus on generating superior returns for investors from the
fast-growing sectors and technologies that will define our future; EMV Capital
invests in, manages and strengthens early stage IP-rich companies.

EMV Capital holds both direct equity stakes and carried interest in its
portfolio companies, creating an evergreen structure that supports extensive
growth and value creation. EMV Capital's investment thesis is realised through
these capital sources:

·     capital-efficient investments through Group balance sheet;

·     fund management of the Evergreen EIS and Martlet Capital Funds;

·     syndicated investments leveraging its network of third-party
investors.

EMV Capital's approach is characterised by its proactive management style,
aiming to advance portfolio companies to critical value inflection points by
actively engaging with them. Companies are supported through Board
representation and the use of its Value Creation Services practice.

Headquartered in London, with a Cambridge presence and strong international
links, EMV Capital is quoted on the AIM market of the London Stock Exchange.

www.emvcapital.com (http://www.emvcapital.com/)

 

About PDS Biotechnology

 

PDS Biotechnology is a late-stage immunotherapy company focused on
transforming how the immune system targets and kills cancers. The Company
plans to initiate a pivotal clinical trial to advance its lead program in
advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech's
lead investigational targeted immunotherapy Versamune(®) HPV is being
developed in combination with a standard-of-care immune checkpoint inhibitor,
and also in a triple combination including PDS01ADC, an IL-12 fused antibody
drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

 

www.pdsbiotech.com
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fpdsbiotech.us4.list-manage.com%2ftrack%2fclick%3fu%3d407bd594246e0ad6fd93882af%26id%3d4baca8d283%26e%3d5ec0d8129e&c=E,1,KvEMXzHVPivn_h59beCKD2b_rhhDVx-4ziC0t3oALRfo2FM7mgMIuHWmX-SXM6LC6pgLg6lH76m1GY6b8W8CK4bNjoUm1xU8aSqWH3PZSIKX_Q_9GLwXuml0a9c,&typo=1)

 

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  FURBLGDXDDGDGUR