PDS Biotech Reports Promising Phase 2 Results for HPV16-Positive Head and Neck Cancer

PDS Biotech’s Survival Data and Phase 2 Trial in Head and Neck Cancer

Announcement

The PDS biotechnology corporation, a leading late-stage immunotherapy company, aims to transform the ability of the immune system to kill and target cancers, proudly announced final excellent survival data from its VERSATILE-002 phase 2 clinical trial. The versatile-002 evaluated PDS0101 (Versamune HPV) plus Keytruda (pembrolizumab) in HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (1L R/M HNSCC).

Phase 2 Clinical Trial Details

Around 53 patients were enrolled in the 1L R/M HNSCC trial. The PDS0101 was led by subcutaneous injection with the 4th infusion of pembrolizumab in the first 4 treatment cycles. The final 5th subcutaneous PDS0101 dose was administered on the 12th cycle. On each cycle where PDS0101 was unsupervised, the pembrolizumab monotherapy was managed. This continued till the disease reached progression with the death or to cycle 35. The median overall survival (MOS) is 39.3 months in CPS >1 patients. The lower limit of the 95% interval is 23.9 months, and the upper limit has not yet been measured.

The durable patient survival is popularized by a high level of multifunctional, long-term HPV16-specific CD8+ T cells influenced by PDS0101 and was similar across the clinical characteristics and patient demographics, like CPS status, prior treatment, and age.

Views and Statements from the Company Leaders

MD, Chief Medical Officer of PDS Biotech, Dr. Kirk Shepard said, “We expect this final result of excellent survival data from our VERSATILE-002 clinical trials will contribute to the durability of clinical effect of PDS0101 with matchable commitment to the survival outcomes showed in recent published studies, the NCI-led study and IMMUNOCERV study in the HPV16-positive recurrent and/or metastatic cancers.” Further, “We believe that the PDS0101, which is easy and simple to administer, will bring hope to the increasing population of patients with HPV16-positive head and neck cancer. We are looking forward to publishing the full data prepared for this trial later this year.”

PhD, President and Chief Executive Officer of PDS Biotech, Frank Bedu-Addo, said, “Following these results, PDS Biotech is suitable for leadership in the huge and most rapidly increasing segment of HNSCC in Europe and the US. The HPV16-positive HNSCC states a prominent and increased unmet medical need, a focused target to treat the cause of the condition, with an urgent need. We hope the oncologist will consistently prioritize therapies that give a chance to the patients to survive.”