Phase 1 study met primary endpoints, showed safety and tolerability at the maximum tolerated dose, and generated protocol-defined immune responses in 74% of participants

SAN JOSE, Calif., April 1, 2026 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ:ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it has entered into a development and manufacturing agreement with Cytovance Biologics (www.cytovance.com), a leading full-service contract development and manufacturing organization ("CDMO") specializing in mammalian and microbially expressed biologics, to produce cGMP clinical materials for its planned Phase 2 clinical trial of its breast cancer vaccine.

The agreement follows positive final Phase 1 results in which the investigational vaccine met all primary endpoints, was safe and well tolerated at the maximum tolerated dose, and generated protocol-defined immune responses in 74% of participants. Based on these results, Anixa is advancing preparations for a Phase 2 clinical trial.

Anixa's breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin—a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By generating an immune response against α-lactalbumin-expressing cells, the vaccine is designed to potentially provide both therapeutic and preventive benefits for patients with tumors expressing this protein. The vaccine is based on preclinical research led by the late Vincent Tuohy, Ph.D., who served as the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic.