After publication of the INK Morning Report this morning, IMV (IMV) released an update on its DPX-Survivac Program following a routine meeting with the FDA.
In the release the company reports:
the FDA acknowledged the potential for accelerated approvals in advanced ovarian cancer based on objective response rate (ORR) according to RECIST 1.1 criteria with reported median duration of response (DOR). In addition, the FDA provided important guidance on clinical design considerations for different lines of therapy and platinum-sensitive and -resistant patient populations.
In addition, IMV submitted a protocol amendment for a predictive enrichment approach to the phase 2 DECIDE trial.
The company also reports that multiple clinical sites are now open for enrollment in the DECIDE phase 2 trial.