• New investigator-initiated Phase II trial to evaluate neoadjuvant efti in HR+/HER2-negative breast cancer
• Trial funded by grants and The George Washington University Cancer Center
• Aims to determine pathological complete response after efti monotherapy and in combination with chemotherapy

Immutep Limited has announced the initiation of an investigator-initiated Phase II trial evaluating neoadjuvant eftilagimod alfa (efti) administered subcutaneously as monotherapy and then in combination with standard-of-care chemotherapy prior to surgery in patients with early-stage HR+/HER2-negative breast cancer. The study will treat up to 50 evaluable patients in a two-stage design and will be primarily funded by grants and The George Washington (GW) University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding. The trial will be led by Principal Investigator, Pavani Chalasani, MD, MPH, Division Director of Hematology and Medical Oncology at the GW Cancer Center. The goal of the multi-center study is to determine pathological complete response (pCR) after neoadjuvant efti treatment and neoadjuvant chemotherapy (NAC). Efti's targeting and unique activation of powerful antigen-presenting cells via MHC Class II leads to a broad anti-cancer immune response, including the activation and proliferation of cytotoxic CD8+ T cells. This novel immunotherapy has yielded encouraging clinical results in metastatic disease and earlier-stage disease in its initial trial as a neoadjuvant treatment in soft tissue sarcoma.

Immutep believes this novel immune system activator can play a meaningful role in metastatic settings and in the ongoing expansion of immunotherapy into neoadjuvant settings to fight cancer.