Anixa Biosciences Advances Breast Cancer Vaccine to Phase 2 Following Successful Phase 1 Trial
Key Insights
Anixa Biosciences' breast cancer vaccine met all primary endpoints in Phase 1, demonstrating safety and tolerability at the maximum tolerated dose.
The investigational vaccine generated protocol-defined immune responses in 74% of participants, supporting advancement to Phase 2 clinical trials.
The company has partnered with Cytovance Biologics (search) for cGMP manufacturing of clinical materials needed for the upcoming Phase 2 study.
Anixa Biosciences has announced positive Phase 1 results for its investigational breast cancer vaccine, meeting all primary endpoints and demonstrating strong immune responses in 74% of participants. The biotechnology company is now advancing toward Phase 2 clinical trials after securing a manufacturing partnership with Cytovance Biologics (search) for cGMP clinical material production.
Phase 1 Trial Results Demonstrate Safety and Immunogenicity
The Phase 1 study successfully met its primary endpoints, showing the vaccine was safe and well tolerated at the maximum tolerated dose. Most significantly, the vaccine generated protocol-defined immune responses in 74% of participants, providing strong evidence of the treatment's immunogenic potential.
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."
Novel Target Mechanism for Breast Cancer Prevention and Treatment
The breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin (search)—a lactation-associated protein that is typically expressed only in breast tissue during lactation but 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. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa, with Cleveland Clinic entitled to royalties and other commercialization revenues.
Manufacturing Partnership Supports Phase 2 Advancement
Anixa has entered into a development and manufacturing agreement with Cytovance Biologics (search), a leading full-service contract development and manufacturing organization specializing in mammalian and microbially expressed biologics. The partnership will focus on producing cGMP clinical materials for the planned Phase 2 clinical trial.
"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 (search). "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."
Cytovance Biologics (search) 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, the company has offered integrated services supporting clients from molecule to commercial manufacturing.
Broader Cancer Vaccine Portfolio
The breast cancer vaccine represents part of Anixa's broader vaccine portfolio, which includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent both breast cancer and ovarian cancer, as well as additional cancer vaccines targeting 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.
Dr. Kumar indicated that the company expects to provide near-term updates on progress toward the Phase 2 trial as preparations advance.