Prima BioMed (ASX:PRR) has announced the first patient has been dosed as part of the enlarged randomised phase of its AIPAC Phase 2b clinical trial for IMP321 in metastatic breast cancer.
IMP321 is a first-in-class Antigen Presenting Cell (APC) activator based on the immune checkpoint target LAG-3. As an APC activator, IMP321 boosts the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T cell response.
The randomised phase of AIPAC (Active Immunotherapy PAClitaxel) will see half of the 226 patients receiving paclitaxel plus a placebo and half receiving paclitaxel in conjunction with IMP321.
This follows the Dose Escalation Committee approval of the 30mg dosage level for IMP321 and commencement of the randomised study late last year.
Prima’s Chief Medical Officer, Dr Frédéric Triebel, said: “We are pleased to have dosed the first patient in the randomised and double-blind Phase of the AIPAC trial. Following positive interim data released in December and the 30mg dosage approval, we are now focused on screening and enrolment of the enlarged patient cohort across our European centres.”