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
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 (Identifier: NCT06790966).
A full version of PDS Biotech's announcement can be accessed here:
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For more information, please contact:
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| EMV Capital plc | via Rosewood |
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Ilian Iliev, CEO |
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| Panmure Liberum (UK) Limited (NOMAD and Broker) | +44 (0)20 7886 2500 |
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Emma Earl / Will Goode / Freddy Crossley / Mark Rogers (Corporate Finance) |
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Rupert Dearden (Corporate Broking) |
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| 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.
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.
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