Presentation of efficacy and safety data from VERSATILE-002 phase II clinical trial in recurrent or metastatic head and neck cancer at ASCO 2022.- PDS Biotechnology.

VERSATILE-002 is a single-arm Phase II study evaluating the safety and efficacy of PDS 0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune technology, in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab). The combination is being evaluated in checkpoint inhibitor (CPI) -naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). In the VERSATILE-002 clinical trial, patients are being treated with Keytruda 200 mg by IV infusion every three weeks, plus subcutaneous injection of PDS 0101 for the first 4 treatment cycles (Cycles 1-4) and again on Cycle 12; Keytruda treatment continues for up to 35 cycles, or until disease progression or demonstrated intolerance to therapy.

Highlights of the abstract from 19 patients (safety) with available imaging data for 17 of the 19 (efficacy) in the VERSATILE-002 clinical trial include: Response rates thus far: i. Tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients in comparison to the published results of approximately 19% for approved checkpoint inhibitors used as monotherapy for recurrent or metastatic head and neck cancer, with 2 of the 7 having complete responses (CR) . ii. Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30% . iii. Clinical efficacy (ORR + SD) was seen in 13/17 (76.5%) patients. iv. Progressive/ongoing disease was reported in 4/17 (23.5%) patients. v. Patients had received a median of 4/5 doses of PDS 0101 (range 1-5) and 9/35 doses of Keytruda (range 1-18). vi. There were no treatment-related adverse events greater than or equal to Grade 3 (N=19). vii. No patients required dose interruption or reduction on the combination treatment. vii. No patients discontinued the combination treatment.

At 9 months of follow up (median not yet achieved):.a Progression free survival (PFS) rate was 55.2%. b. Overall survival (OS) rate was 87.2%. The data being presented at ASCO will detail preliminary safety and efficacy data for CPI-naïve patients at a prespecified interim analysis point.