Precigen: FDA OK for Phase 2 Study of Off-the-Shelf Immunotherapy Combo for Cervical Cancer

 –  HPV is responsible for more than 90 percent of cervical cancer cases globally with approximately 300,000 women living with cervical cancer in the US –

–  Current response rates to second line treatments in recurrent or metastatic cervical cancer are very low and associated with a high rate of toxicity –

– PRGN-2009 is designed to generate de novo T-cell immune response against HPV 16/18-positive solid tumors cells and is differentiated from other platforms due to the ability of gorilla adenovectors to enable repeat administrations –

–  PRGN-2009 Phase 1 data to be presented at the 2023 ASCO annual meeting on June 3 (Abstract # 2628); PRGN-2009 in combination with a checkpoint inhibitor demonstrated a favorable safety profile and resulted in a 30% ORR in patients with heavily pre-treated HPV-associated cancers, including those who have previously failed checkpoint inhibitors –

–  Phase 2 study of PRGN-2009 is in combination with pembrolizumab in the second line setting in patients with recurrent or metastatic cervical cancer previously treated with pembrolizumab for recurrent or metastatic disease –

–  CMC path in place to support delivery of product for Phase 2 study as well as future framework to support potential pivotal trials –

https://www.biospace.com/article/releases/precigen-receives-fda-clearance-of-ind-to-initiate-phase-2-study-of-prgn-2009-off-the-shelf-adenoverse-immunotherapy-in-combination-with-pembrolizumab-to-treat-patients-with-recurrent-or-metastatic-cervical-cancer/