Immutep Limited, a clinical-stage biotechnology company specializing in advanced LAG-3 immunotherapies, has announced the completion of patient enrolment for its Phase II AIPAC-003 clinical trial. This trial aims to assess the efficacy of its investigational agent, eftilagimod alpha (“efti”), in combination with the chemotherapy drug paclitaxel, for individuals with metastatic breast cancer.

The trial has now successfully recruited 65 patients, focusing specifically on individuals with metastatic hormone receptor-positive (HR+), HER2-negative/low, or triple-negative breast cancer who have exhausted available endocrine therapies, including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Participants were enrolled across 22 clinical sites in Europe and the United States, highlighting the significant international interest in Immutep’s innovative therapeutic approach.

Key Details of the AIPAC-003 Trial

The AIPAC-003 trial is a randomized Phase II study evaluating eftilagimod alpha (efti) as an immune response enhancer against cancer. Participants have been randomized into two cohorts, each receiving either 30 mg or 90 mg doses of efti in combination with paclitaxel. This dosing strategy is designed to identify the optimal biological dosage, in alignment with the U.S. Food and Drug Administration’s Project Optimus initiative. Project Optimus represents an FDA effort to promote more individualized and effective cancer treatment through optimal drug dosing paradigms.

With Phase II enrolment now complete, Immutep is progressing to the subsequent phase—data collection, data cleaning, and statistical analysis. This step is pivotal in determining whether the combination of efti and paclitaxel results in significant clinical benefit for patients who face limited therapeutic options. Immutep has emphasized its commitment to maintaining transparency and providing regular updates as the trial data undergoes processing and analysis.

A Step Towards Improved Immunotherapy

Eftilagimod alpha forms a key component of Immutep’s diversified therapeutic pipeline that seeks to exploit the Lymphocyte Activation Gene-3 (LAG-3) pathway to either stimulate or modulate immune responses. In oncologic applications, efti functions as an immunostimulatory agent, enhancing the patient’s immune response to more effectively recognize and eliminate cancer cells. This approach has garnered considerable attention within the oncology community, given its potential to provide a safer and more efficacious treatment alternative with a reduced side effect profile compared to conventional chemotherapy.

Expert analysis of Immutep’s ongoing research remains cautiously optimistic. Industry analysts have indicated that the AIPAC-003 trial represents a meaningful advance in the establishment of eftilagimod alpha as a viable immunotherapeutic candidate in the global oncology landscape. The combined use of efti and paclitaxel could provide renewed hope for patients with metastatic breast cancer, particularly those who have exhausted other therapeutic avenues. Experts underscore that identifying the optimal dosing regimen is crucial, and Immutep’s alignment with the FDA’s Project Optimus provides a solid regulatory framework for the trial.

Share Price and Market Sentiment

Shares of Immutep Limited (ASX: IMM; NASDAQ: IMMP) have demonstrated positive momentum following the enrolment completion announcement. Market analysts are closely monitoring the situation, as favorable trial outcomes could lead to significant returns for shareholders. Moreover, Immutep is expected to attract heightened institutional interest, given the promising outlook of its therapeutic pipeline and the successful achievement of enrolment milestones. As the trial progresses, the company aims to further consolidate its leadership in the field of LAG-3 based immunotherapies.

  AIPAC-003, Breast Cancer, eftilagimod alpha, Europe, FDA, Immutep Limited, LAG-3, Project Optimus, Sydney