Immutep announces initiation of Phase II/III trial for eftilagimod alpha

Immutep announced the initiation of AIPAC-003, an integrated Phase II/III trial to evaluate eftilagimod alpha in combination with paclitaxel for the treatment of metastatic HER2-neg/low breast cancer. Regulatory approval has been received in the US and Institutional Review Board approval has been received in Spain, with approvals in additional countries anticipated to follow shortly. The first patient is expected to be enrolled in early Q2 CY2023. Immutep 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-PD-1 therapy in 1st line head & neck squamous cell carcinoma and 1st line non-small cell lung cancer." The Company and the US Food and Drug Administration agreed to the integrated Phase II/III trial design for AIPAC-003 that will help inform a Biologics License Application. Additionally, the trial design incorporates feedback from Scientific Advice meetings with the European Medicines Agency to support a Marketing Authorisation Application. With respect to the late-stage clinical development of efti, the Phase II portion of the MBC trial, the ongoing randomized/controlled Phase II trial in 1st line HNSCC, and the initiation of the registrational trial in 1st line NSCLC are included in the budget and have no impact on the Company’s expected cash runway to the end of the 1st half of calendar year 2024.