Precigen received FDA clearance to initiate Phase 2 study of PRGN-2009 in cervical cancer

CAR-T Digest - August 2020

May 31, 2023: PRGN-2009 (SC) / Cervical Cancer / Precigen: US FDA approval to initiate Phase 2 trial

Precigen announced that the US FDA has approved IND application to initiate a Phase 2 study of PRGN-2009 Off-the-Shelf AdenoVerse™ immunotherapy in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer
PRGN-2009 Phase 1 data to be presented at the ASCO 2023:
- 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
- PRGN-2009 showed a favorable safety profile with no DLT
“We are encouraged by the 30% ORR in the Phase 1 study which demonstrated a favorable safety profile with no dose-limiting toxicities, strong antigen-specific immune response, and lack of significant neutralizing antibody response upon repeat administrations in combination with a checkpoint inhibitor…. Additionally, we are pleased that in collaboration with FDA, we have agreed upon a CMC path to support the delivery of product for the Phase 2 study as well as a future framework to support potential pivotal trials.” said Helen Sabzevari, Ph.D., President and CEO of Precigen