PDS Biotechnology Corporation (NASDA: PDS) has announced that its VERSATILE-002 second phase study of advanced human papillomavirus (HPV)-related head and neck cancer treatment attained the primary objective response goal.
VERSATILE-002 conducted in two cohorts
VERSATILE-002 is progressing in two cohorts of HPV16+ head and neck cancer participants whose disease has spread or returned or, in partnership with Merck (popular as MSD outside North America). The first cohort (CPI nave) has never been medicated with a checkpoint inhibitor. The combination is currently being tested in the second cohort of 21 subjects who failed previous checkpoint inhibitor therapy (CPI refractory).
The study, which is testing PDS0101 in conjunction with Merck’s anti-PD-1 treatment KEYTRUDA® (pembrolizumab), expects to recruit the remaining 54 participants in this cohort of CPI-naive patience accomplishment of objective response as evaluated by radiographic cancer cell responses as per RECIST 1.1 (cancer cell reduction of more than 30%) confirmed by two different metrics in more than four of the first 17 subjects in the CPI nave arm enables that arm to proceed to full registration, as indicated in the clinical study design.
PDS Chief Medical Officer Dr. Lauren Wood said, “The achievement of this important milestone in the VERSATILE-002 Phase 2 clinical trial strengthens the evidence of our novel Versamune® platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer to achieve tumor regression.”
PDS0101 combination with KEYTRUDA has demonstrated efficacy
The preliminary data support our opinion that PDS0101’s shown preclinical efficacy in combination with KEYTRUDA® can enhance clinical results for people with advanced HPV16+ head and neck cancer.
By producing enormous amounts of high-quality, very powerful polyfunctional tumor-specific CD8+ killer T-cells and CD4+ helper in vivo, Versamune-based treatments have shown the ability to overcome the limits of existing immunotherapies. In addition, the company has developed many medicines that use a combination of Versamune and disease-specific antigens to teach the immune system to detect sick cells and try to destroy them more efficiently.
