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.

Insights

Medical Research Analyst

The completion of patient enrollment in the randomized Phase II portion of the AIPAC-003 trial is a significant milestone for Immutep. This study focuses on metastatic breast cancer patients who have exhausted endocrine therapy options, including CDK4/6 inhibitors. The trial's design, comparing 30mg and 90mg doses of eftilagimod alpha (efti) with paclitaxel, aligns with the FDA's Project Optimus initiative, aiming to optimize dosing in oncology.

The trial's scope, involving 65 patients across 22 clinical sites in Europe and the US, provides a robust sample for evaluating efti's efficacy. This LAG-3 immunotherapy approach could potentially offer a new treatment option for patients with alternatives. However, it's important to note that while enrollment completion is positive, the true value lies in the upcoming data analysis.

Investors should monitor for future updates on data collection and analysis, as these results will be critical in determining efti's potential market impact and Immutep's future prospects in the competitive oncology field.

Financial Analyst

From a financial perspective, the completion of patient enrollment in this Phase II trial is a positive development for Immutep (NASDAQ: IMMP). It signifies progress in their clinical pipeline, which is important for biotech companies with a $309 million market cap. This milestone could potentially increase investor confidence and support the stock price in the short term.

However, it's important to note that the real value driver will be the trial results. Positive data could significantly boost Immutep's market valuation and potentially attract partnership opportunities or additional funding. Conversely, negative results could have a substantial adverse impact.

Investors should consider the company's cash position and burn rate, as clinical trials are expensive. The timeline for data analysis and potential regulatory submissions will be critical in assessing the company's financial needs and strategic options going forward. While this news is encouraging, it's prudent to await the trial results before making significant investment decisions.

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

FAQ

What is the purpose of Immutep's AIPAC-003 trial for IMMP stock?

The AIPAC-003 trial aims to determine the optimal biological dose of eftilagimod alpha (efti) in combination with paclitaxel for treating metastatic breast cancer patients who have exhausted endocrine therapy including CDK4/6 inhibitors.

How many patients were enrolled in the Phase II portion of IMMP's AIPAC-003 trial?

The Phase II portion of the AIPAC-003 trial enrolled 65 metastatic breast cancer patients across 22 clinical sites in Europe and the United States.

What are the dosing regimens being tested in Immutep's AIPAC-003 trial for IMMP stock?

Patients in the AIPAC-003 trial were randomised 1:1 to receive either 30mg or 90mg dosing of eftilagimod alpha (efti) in combination with paclitaxel.

When will Immutep (IMMP) provide results from the AIPAC-003 trial?

Immutep has stated that further updates will be provided after data collection, data cleaning, and analysis. No specific timeline was mentioned in the press release.