Immutep completes patient enrolment in AIPAC-003 trial

Immutep Limited (ASX:IMM) has successfully completed patient enrolment in the randomised Phase II portion of the AIPAC-003 clinical trial. The trial enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of eftilagimod alpha ('efti') in combination with paclitaxel to determine the optimal biological dose consistent with the FDA's Project Optimus initiative.

Executive Commentary

We are pleased to have completed patient enrolment in the randomised Phase II portion of the AIPAC-003 trial. This marks a significant milestone in our efforts to develop novel LAG-3 immunotherapies for metastatic breast cancer. The trial's focus on determining the optimal biological dose of eftilagimod alpha in combination with paclitaxel is aligned with the FDA's Project Optimus initiative, and we look forward to further updates after data collection, data cleaning, and analysis.

Summary

Immutep Limited (ASX:IMM) has achieved a key milestone by completing patient enrolment in the randomised Phase II portion of the AIPAC-003 trial for metastatic breast cancer. The trial enrolled 65 patients across 22 clinical sites in Europe and the United States to determine the optimal biological dose of eftilagimod alpha in combination with paclitaxel. The company remains dedicated to leveraging its expertise in LAG-3 immunotherapy to bring innovative treatment options to patients and maximize value for shareholders. Further updates on the trial's progress are anticipated after data analysis, and Immutep continues to focus on advancing therapeutics for cancer and autoimmune disease.