Immutep announces completion of lead-in, opening of Phase II study of AIPAC-003

Immutep Limited announces the open-label safety lead-in of its integrated AIPAC-003 Phase II/III trial evaluating for the very first time 90mg of eftilagimod alpha in combination with paclitaxel has been completed with no safety or tolerability issues. Six patients with metastatic breast cancer receiving this immuno-oncology chemotherapy combination, after exhaustion of all endocrine/CDK4/6 based therapies, tolerated the therapy very well and there were no dose limiting toxicities, as confirmed by the independent Data Monitoring Committee appointed for the trial. The IDMC recommended proceeding to the randomised Phase II portion of the trial. The randomised Phase II portion of the study will now open to include up to 58 evaluable patients with metastatic breast cancer receiving either 30mg efti or 90mg efti to determine the optimal biological dose. The evaluation of 90mg efti dosing in combination with paclitaxel is driven by efti’s excellent safety profile, along with the FDA’s Project Optimus initiative in oncology. Importantly the determination of the optimal biological dose is relevant for the whole efti program across all disease indications.