ANIX

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. Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "With final Phase 1 data demonstrating safety, tolerability, and strong immune responses in 74% of participants, we are focused on advancing this program toward Phase 2. Our agreement with Cytovance represents an important operational milestone as we work to secure cGMP clinical supply for the next stage of development." Dr. Kumar continued, "As we advance toward the Phase 2 trial, we expect to provide near-term updates on our progress." "We are pleased to partner with Anixa to manufacture clinical materials for its Phase 2 breast cancer vaccine trial," said Ping Zhang, CEO of Cytovanc...

Phase 1 Data Highlights Potential of First-in-Class Vaccine to Transform Breast Cancer Treatment and Prevention Comprehensive Results, Supported by U.S. Department of Defense Funding, to Inform FDA Discussions and Advance Phase 2 Development Plans SAN JOSE, Calif., Sept. 22, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that final results from the Phase 1 clinical trial of its breast cancer vaccine will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Thursday, December 11, 2025. The trial, conducted at Cleveland Clinic and funded by a grant from the U.S. Department of Defense, evaluated the safety and immunogenicity of an alpha-lactalbumin (aLA) vaccine for breast cancer. The presentation, titled "Final Results of a Phase I Trial of alpha-lactalbumin (aLA) Vaccine for Breast Cancer," will be delivered by Justin Johnson, Ph.D., Program Manager at Cleveland Clinic and co-inventor of the vaccine technology. With the trial now complete and comprehensive analyses of blood and tissue samples underway, this presentation at SABCS will represent the most detailed data release to date. A full report of the findings will also be submitted to the U.S. Department of Defense, which funded the study, and separately to the U.S. Food and Drug Administration (FDA) to inform upcoming Phase 2 planning discussions. Presentation Details: Abstract Number: 765 Presentation Number: PS4-06-19 Presentation Title: Final Results of a Phase I Trial of an Alpha-lactalbumin (aLA) Vaccine for Breast Cancer Poster Presentation: Thursday, December 11, 2025, 5:00–6:30 PM CST "We are very encouraged by the data generated in this human clinical trial, which continues to exceed our expectations," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "This vaccine builds on decades of pioneering preclinical work led by the late Vincent Tuohy, Ph.D. and his team at Cleveland Clinic. His visionary research, has brought us to this pivotal moment—one that has the potential to transform the future of breast cancer prevention and treatment." About Anixa Biosciences, Inc. Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy...