PDS Biotechnology CorporationPDSB announced expanded interim data in the Phase 2 trial investigating the PDS0101-based triple combination therapy in advanced human papillomavirus (HPV)-positive cancers.
The triple combination of PDS0101 with the tumor-targeting IL-12 fusion protein M9241 and bintrafusp alfa is being studied in CPI-naïve and CPI-refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers.
Median overall survival is 21 months in 29 checkpoint inhibitor refractory patients who received the triple combination. The reported historical median OS in patients with CPI refractory disease is 3-4 months.
In CPI naïve subjects, 75% remain alive at a median follow-up of 27 months. As a result, the median OS has not yet been reached. Historically median OS for similar patients with platinum-experienced CPI naïve disease is 7-11 months.
The objective response rate (ORR) in CPI refractory patients who received the optimal dose of the triple combination is 63% (5/8). In current approaches, ORR is reported to be less than 10%.
ORR in CPI naïve patients with the triple combination is 88%. In current approaches, ORR is reported to be less than 25% with FDA-approved CPIs in HPV-associated cancers.
Price Action: PDSB shares are up 8.564% at $10.00 on the last check Wednesday.
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