PDS Biotech VERSATILE-002 Phase 2 Clinical Trial Meets Primary Study Endpoints in First Line Recurrent/Metastatic HPV16-Positive Head and Neck Cancer

NetScientific PLC Reports Positive Results from PDS Biotech's VERSATILE-002 Phase 2 Clinical Trial

NetScientific PLC has reported positive results from its portfolio company, PDS Biotechnology Corporation, regarding the VERSATILE-002 trial. The trial evaluated Versamune® HPV + KEYTRUDA® (pembrolizumab) in patients with HPV16-positive head and neck squamous cell cancer (HNSCC). The trial met its primary endpoint, with a median overall survival of 30 months in first-line recurrent metastatic HNSCC, which is significantly higher than the published results for immune checkpoint inhibitors.

The immune checkpoint inhibitor (ICI) naïve cohort also met its primary endpoint of best overall response, with a 34% response rate for CPS≥1 and 48% for CPS≥20. Additionally, the combination of Versamune® HPV + pembrolizumab was well tolerated. Based on these positive results, the company announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune® HPV + PDS01ADC + pembrolizumab as a first-line treatment in HPV16-positive recurrent/metastatic HNSCC.

PDS01ADC is the company's novel, investigational tumour-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune® HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute. The first part of the clinical trial will focus on dose optimization, while the randomized second part will include an interim data readout with overall survival as its primary endpoint.

NetScientific PLC is a deep tech and life sciences VC investment group with an international portfolio of innovative companies. 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. PDS Biotechnology, a late-stage immunotherapy company in NetScientific's portfolio, is focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers (HNSCC).

The positive results from the VERSATILE-002 trial indicate a promising future for PDS Biotechnology's immunotherapy approach, and the company's updated clinical strategy reflects its commitment to advancing innovative treatments for HPV16-positive HNSCC.