REG - EMV Capital PLC - PDS Biotech reaffirms guidance for clinical trial

EMV CapitalAnnouncement

05/02/2025 15:30

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RNS Number : 0665W  EMV Capital PLC  05 February 2025

For immediate release

 

EMV Capital plc

 

("EMVC" or the "Company")

 

PDS Biotech Reaffirms Guidance for First Quarter Initiation of VERSATILE-003
Phase 3 Clinical Trial in HPV16-Positive Recurrent/Metastatic Head and Neck
Squamous Cell Carcinoma

 

FDA-cleared amended trial design

First site initiation expected Q1 2025

 

EMV Capital plc (AIM: EMVC), the deeptech and life sciences VC investment
group, reports that its portfolio company PDS Biotechnology Corporation
(Nasdaq: PDSB) in which it holds a 2.8% direct holding has reaffirmed its
guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune®
HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic
(R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first
quarter of this year.

 

PDS Biotech is a late-stage immunotherapy company focused on transforming how
the immune system targets and kills cancers.

 

PDS Biotech submitted its updated clinical protocol on 15 November 2024,
amending the Investigational New Drug (IND) application. The window for
comments from the US Food and Drug Administration (FDA) has passed, and the
Company is on track to initiate site activation in the first quarter of 2025.
The Company has received Fast Track designation from the FDA for the
combination of Versamune(®) HPV and pembrolizumab in R/M HNSCC.

 

See VERSATILE-002 Phase 2 clinical results here:
https://pdsbiotech.com/images/pdf/presentation/2024/ESMO_2024_Poster_Final_14SEP2024_1.pdf
(https://pdsbiotech.com/images/pdf/presentation/2024/ESMO_2024_Poster_Final_14SEP2024_1.pdf)

 

Dr Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS
Biotech said:

 

"The integral elements for trial initiation are ready, including alignment
with the FDA. We look forward to initiating VERSATILE-003 this quarter and
advancing the combination of Versamune® HPV plus pembrolizumab to potentially
provide improved outcomes for patients with HPV16-positive R/M HNSCC."

 

HPV16-positive patients represent a large, fast-growing subgroup in need of
targeted therapies to treat the underlying cause of the cancer. A recently
validated companion diagnostic to confirm HPV16-positive HNSCC will be
utilised during the patient screening process of the VERSATILE-003 trial.

 

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

 

"PV16-positive HNSCC is poised to become the dominant type of HNSCC in the US
and EU. Confirming HPV16 status with a potentially commercialisable test is
essential to effectively identifying the patients suitable to receive
Versamune HPV. This will be the first investigational use of this type of
companion diagnostic in a Phase 3 clinical trial in HNSCC."

 

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%2CBSuk5IE01v_-BGPN4a0rQXbX0SF88d1l9VX_ZLlkJK_RbCFIbiFys85xO6z7UpoctsU6uH2A25GrrG4aiWeBLf2JBTyYowewlzAKF6cDhg9MIcYTR7avbg%2C%2C%26typo%3D1%26ancr_add%3D1&data=05%7C02%7Clpearce%40rosewoodpr.co.uk%7C97aa1ddd9d4d4d6cbd4f08dd45eb8a6f%7Cb9b2cf7e777c4d0caf8dae122314ff67%7C0%7C0%7C638743600133003292%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=7fVIQBYY%2FXNP6mfNx7ZggHUCASE0nBSDZzz9RlJlrTs%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%253d34e633aeb9%2526e%253d27d88613f0%26c%3DE%2C1%2CbW5mez3LqKhztmmGY-H450_TuM3W6i3IZB1GYfCuFyu6JBVGkRsNBOn7MTslNm6mZ2vPB2JnKZM2G5yzT8BwRKT3KP0dHPJ0-2Tc_BttHg%2C%2C%26typo%3D1&data=05%7C02%7Clpearce%40rosewoodpr.co.uk%7C97aa1ddd9d4d4d6cbd4f08dd45eb8a6f%7Cb9b2cf7e777c4d0caf8dae122314ff67%7C0%7C0%7C638743600133019935%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ZOnFUG59CctTGcmETcihSzPzY7YLauORgR2MN%2Fbbq0M%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/968-iotecheaffirmsuidanceforirstuarternitiation20250205
(https://pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/132-2025-news/968-iotecheaffirmsuidanceforirstuarternitiation20250205)

 

-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 / Llew 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 T-cell stimulating 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 (http://www.pdsbiotech.com)

 

 

 

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