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TVI-Breast-1 is an autologous T cell immunotherapy being developed by TVAX Biomedical for the treatment of breast cancer. The therapy is based on the TVAX Immunotherapy platform, a unique two-step approach that combines a cancer vaccine with adoptive T cell transfer. In the first stage, patients are vaccinated with their own irradiated tumor cells combined with an adjuvant (typically GM-CSF) to sensitize the immune system and generate 'pre-effector' T cells. These sensitized T cells are subsequently harvested from the patient's blood via leukapheresis, activated and expanded to large numbers *ex vivo* using interleukin-2 (IL-2), and then re-infused into the patient. Once re-infused, these activated effector T cells are capable of trafficking to and destroying tumor cells throughout the body. The program is currently in Phase 2 clinical development.
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