Initial Clinical Results for 90mg Efti Dosage

Immutep, a clinical-stage biotechnology firm, has reported positive safety and preliminary efficacy data from the initial 90mg dosage of eftilagimod alpha (efti) combined with weekly paclitaxel in the AIPAC-003 Phase II/III trial. The data, derived from the safety lead-in phase with six patients, showed no serious adverse events and all adverse events were mild.

Six patients with HR-positive/HER2-negative/low metastatic breast cancer (MBC), who had exhausted endocrine therapy including CDK4/6 inhibitors, displayed a 50% overall response rate with one complete response and two partial responses. Additionally, all patients achieved a 100% disease control rate, with the remaining three having stable disease.

While recognizing the early stage of these results, the combination of efti and paclitaxel has historically shown a dose-dependent effect in MBC, and the 30mg efti dose, previously the highest tested, has shown a stronger immune response and greater efficacy than lower doses.

The ongoing Phase II part of the AIPAC-003 trial, which will involve up to 58 evaluable patients, is assessing the safety and efficacy of the 90mg efti dose compared to the 30mg dose. The trial has enrolled 23 patients so far, and the determination of the optimal biological dose is aligned with the FDA’s Project Optimus initiative, impacting the entire efti program.

Efti is Immutep’s proprietary LAG-3 protein and MHC Class II agonist, which stimulates both innate and adaptive immunity to treat cancer. As an APC activator, it activates various immune cells and boosts the immune system’s ability to combat cancer.

Efti is being evaluated for several solid tumors, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favorable safety profile allows for various combinations with treatments such as anti-PD-[L]1 immunotherapy and chemotherapy. The FDA has granted Fast Track designation for efti in first-line HNSCC and NSCLC.

Immutep is a pioneer in LAG-3 immunotherapy for cancer and autoimmune diseases, with a diversified product portfolio that leverages LAG-3’s ability to stimulate or suppress immune responses. The company is committed to providing innovative treatment options for patients and maximizing shareholder value.