Immutep enters reseach collaboration with GW University Cancer Center

Immutep (IMMP) announces the initiation of an investigator-initiated Phase II trial evaluating neoadjuvant eftilagimod alfa 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 University Cancer Center. Immutep will provide efti at no cost, technical support, and limited funding that falls within its existing budget. The trial will be led by Principal Investigator, Pavani Chalasani, MD, MPH, Division Director of Hematology and Medical Oncology at the GW Cancer Center and a leader of the GW Cancer Center Breast Cancer clinical research team. Efti’s targeting and unique activation of powerful antigen-presenting cells via MHC Class II leads to a broad anti-cancer immune response. This includes the activation and proliferation of cytotoxic CD8+ T cells that can be armed in vivo with chemotherapy-induced tumour antigens, as well as numerous other immune cells and cytokines enhancing the immune system’s ability to fight cancer. 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. The goal of this multi-center study led by the GW Cancer Center is to determine pathological complete response after neoadjuvant efti treatment and neoadjuvant chemotherapy. This is a single-arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer who are eligible for NAC. Enrolled patients will be treated with efti monotherapy for three weeks and then start NAC in combination with efti.