Anixa Biosciences Advances Breast Cancer Vaccine Toward Phase 2 With Selection Of Cytovance Biologics For Cgmp Manufacturing

San Jose, CA - Anixa Biosciences, Inc. (“Anixa” or the “Company”) (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the signing of a development and manufacturing agreement with Cytovance Biologics, a leading full-service contract development and manufacturing organization (“CDMO”) specializing in mammalian and microbially expressed biologics, for the cGMP manufacture of clinical materials to support its planned Phase 2 clinical trial of its breast cancer vaccine.

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.

Final Phase 1 results demonstrated that the investigational vaccine achieved all primary endpoints, was safe and well tolerated at the maximum tolerated dose (MTD), and generated protocol-defined immune responses in 74% of participants. Based on these findings, Anixa intends to advance the program into a Phase 2 clinical trial.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, “Selecting Cytovance for cGMP manufacturing marks a critical step as we prepare to advance our breast cancer vaccine into Phase 2. Our Phase 1 data demonstrated safety, tolerability at the maximum tolerated dose, and a strong immune response in 74% of participants. Cytovance’s expertise in cGMP biologics production provides us with the technical strength and reliability necessary to support our next phase of clinical development.” Dr. Kumar continued, “As we advance toward the Phase 2 trial, we expect to provide 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 Cytovance Biologics. “Our team is committed to delivering high-quality cGMP manufacturing solutions that support innovative biotech programs. We look forward to leveraging our development and production capabilities to help advance this promising immunotherapy candidate.”

About Cytovance

Cytovance Biologics is an established CDMO specializing in the expression and production of therapeutic proteins and antibodies from both mammalian cell culture and microbial fermentation. For 20 years, Cytovance has offered flexibility and ingenuity across a full range of integrated services, supporting clients on their journey from molecule to commercial manufacturing.

Learn more about Cytovance Biologics at www.cytovance.com.
Follow us on LinkedIn: @Cytovance Biologics

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 liraltagene autoleucel, or lira-cel, an ovarian cancer immunotherapy being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system. The Company’s vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against “retired” proteins that have been found to be expressed in certain forms of cancer. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies. Anixa’s unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on LinkedIn, X, Facebook and YouTube