NetScientific Plc reported that its portfolio company, PDS Biotechnology Corporation has announced updated survival data from the Phase 2 clinical trial investigating the triple combination of PDS0101, PDS0301 (IL-12 antibody-drug conjugate) and an investigational immune checkpoint inhibitor (ICI) in two groups of advanced cancer patients with various types of human papillomavirus (HPV) 16-positive cancers. The ICI naive group had not responded to standard-of-care treatments but had not yet been treated with an ICI. The ICI resistant group included patients who had not responded to multiple prior treatments, including ICI therapy.

Investigators at the National Cancer Institute (NCI), part of the National Institutes of Health, have completed the primary endpoint analysis of the Phase 2 trial. In the ICI naive group, final survival data from the trial indicated that 75% (6/8) of these patients were still alive at 36 months, and the median overall survival (OS) has not yet been reached. Published data on standard-of-care ICIs report 30-50% of these patients typically remain alive at 12 months, and less than 30% of the patients remain alive at 24 months.

In the ICI resistant group, the 12-month OS rate was 72% and the triple combination achieved a median OS of approximately 20 months. In addition: For PDS0101 plus high doses of ICI and PDS0301, the overall response rate (ORR) was 63% (5/8). The historical median survival for ICI therapy in HPV-positive cancer ICI resistant patients is reported to be 3.4 months.

The ICI resistant data from the VERSATILE-002 trial evaluating PDS0101 in combination with KEYTRUDA®? (pembrolizumab) that were reported 3 October 2023, further clarify the path forward for a potential registrational clinical trial of PDS0101 and PDS0301 in combination with a commercial ICI. With this exciting information, the company will be finalising the regulatory and clinical pathway for the triple combination with OS as the primary endpoint.

PDS0101, the company's lead candidate, is a Versamune®? based investigational immunotherapy designed to stimulate a potent targeted T cell attack against HPV16-positive cancers. The group secures a mixture of direct equity stakes and carried interest stakes in its portfolio of companies, creating a lean structure that can support a large portfolio.