On October 3, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported patient enrolment has been completed in the randomised Phase II portion of the AIPAC-003 (Active Immunotherapy and PAClitaxel) clinical trial (Press release, Immutep, OCT 3, 2024, View Source [SID1234647006]).
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The Phase II 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.
Further updates will be provided after data collection, data cleaning, and analysis. For more information on the trial, please visit clinicaltrials.gov (NCT05747794).