PDS Biotech reaffirms guidance for clinical trial

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:

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.