NetScientific PLC's portfolio company, PDS Biotechnology Corporation, is set to commence the Phase 3 VERSATILE-003 trial in Q4 2024 for its Versamune®-based investigational immunotherapy targeting HPV16-positive head and neck squamous cell carcinoma (HNSCC). The U.S. Food and Drug Administration (FDA) has provided support for the trial, which will include double and triple combinations of Versamune® with other agents. The company aims to investigate the potential of Versamune® HPV + pembrolizumab as the first targeted immunotherapy for HPV16-positive HNSCC. The trial has garnered significant key opinion leader support and interest from potential trial sites.
PDS Biotech presented recent data from its VERSATILE-002 study and proposed an updated design for the Phase 3 trial, including statistical endpoints based on recent and more mature survival data. The FDA supported the strategy and development of the double and triple combinations, with the Versamune® HPV + pembrolizumab combination having received Fast Track designation. The company's President and CEO, Frank Bedu-Addo, expressed appreciation for the FDA's support and highlighted the potential of the combination to advance the treatment of HPV16-positive HNSCC.
The Phase 3 VERSATILE-003 trial will focus on the first-line treatment of patients with recurrent or metastatic HPV16-positive HNSCC, with overall survival as the primary endpoint. PDS Biotech's Chief Medical Officer, Kirk Shepard, confirmed that the preparatory work for the trial is advancing, with a significant number of target sites expressing strong interest in participating. The company is also considering the addition of PDS01ADC in the future to potentially provide further clinical benefit to the targeted immunotherapy.
NetScientific PLC, a deep tech and life sciences VC investment group, holds a 3% direct holding in PDS Biotechnology Corporation. The company focuses on identifying, investing in, and building high-growth companies in the UK and internationally, adding value through proactive portfolio management and delivering investment returns through liquidity events. NetScientific differentiates itself by employing a capital-efficient investment approach and securing a mixture of direct equity stakes and carried interest stakes in its portfolio of companies.