• Confirmation of 30 mg efti as optimal biological dose
• Registrational TACTI-004 Phase III trial in 1L NSCLC now opening clinical sites
• Efti's optimal dose has strategic relevance for Immutep's oncology pipeline

Immutep Limited, a late-stage immunotherapy company, has announced that it has received positive feedback from the US Food and Drug Administration (FDA) regarding the successful completion of Project Optimus requirements and agreement on 30 mg as the optimal biological dose for eftilagimod alfa (efti). This is a significant milestone that carries strategic importance for Immutep's ongoing and future clinical development of efti, including the global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with pembrolizumab and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. With the conclusion of Project Optimus, the TACTI-004 registrational study is now in the process of opening clinical sites in the United States. Efti is a novel immunotherapy that directly activates antigen-presenting cells to initiate a broad anti-cancer immune response. It is being evaluated for various solid tumors, including NSCLC, head and neck squamous cell carcinoma, soft tissue sarcoma, and breast cancer. Efti has received Fast Track designation in first-line HNSCC and NSCLC from the FDA. Immutep is a late-stage biotechnology company dedicated to developing innovative treatment options for patients in need and maximizing value for shareholders.