Immutep Completes Patient Enrolment in Randomised Phase II of AIPAC-003 Trial in Metastatic Breast Cancer
Rhea-AI Summary
Immutep (ASX: IMM; NASDAQ: IMMP) has completed patient enrolment in the randomised Phase II portion of the AIPAC-003 clinical trial. The trial enrolled 65 metastatic breast cancer patients who have exhausted endocrine therapy including CDK4/6 inhibitors. Patients were recruited from 22 clinical sites in Europe and the United States.
The study is designed to determine the optimal biological dose of eftilagimod alpha ('efti') in combination with paclitaxel, aligning with the FDA's Project Optimus initiative. Patients were randomised 1:1 to receive either 30mg or 90mg dosing of efti. The company will provide further updates after data collection, cleaning, and analysis.
Positive
- Completed patient enrolment for Phase II of AIPAC-003 trial
- Study aligns with FDA's Project Optimus initiative
- Trial conducted across 22 clinical sites in Europe and the US
Negative
- None.
News Market Reaction – IMMP
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Media Release
SYDNEY, AUSTRALIA, Oct. 03, 2024 (GLOBE NEWSWIRE) -- 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, today announces patient enrolment has been completed in the randomised Phase II portion of the AIPAC-003 (Active Immunotherapy and PAClitaxel) clinical trial.
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).
About Immutep
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.
Australian Investors/Media:
Catherine Strong, Sodali & Co.
+61 (0)406 759 268; catherine.strong@sodali.com
U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
