Immutep (ASX:IMM) has announced the initiation of the AIPAC-003 (Active Immunotherapy, Eftilagimod Alpha, and PAClitaxel) clinical trial evaluating its eftilagimod alpha (efti) in combination with paclitaxel for the treatment of metastatic HER2-neg/low breast cancer.
Efti is an investigative LAG-3 immunotherapy currently in development for cancer and autoimmune disease.
The company said the first patient is expected to be enrolled in the second quarter of the calendar year 2023.
CEO Marc Voigt said, “With its novel mechanism of action to activate antigen-presenting cells, efti has to date safely improved clinical outcomes from anti-PD-(L)1 therapies and standard-of-care chemotherapy.
“We look forward to AIPAC-003 building upon the encouraging synergy seen in our previous Phase IIb trial in metastatic breast cancer, especially with its three key adaptations: same-day administration of efti plus paclitaxel, this dual IO-chemotherapy treatment continuing until disease progression, and a new primary endpoint of overall survival. The selected Phase II/III trial design allows us to move forward with a risk-balanced approach in MBC, as we continue our prioritized late-stage clinical development with anti-PD1 therapy in 1st line head and neck squamous cell carcinoma and 1st line non-small cell lung cancer.”