Anixa Biosciences is advancing its breast cancer vaccine programme towards Phase 2 clinical development following the selection of Cytovance Biologics to manufacture clinical trial material under cGMP conditions.

The agreement supports preparation for a planned Phase 2 study of Anixa’s investigational breast cancer vaccine, which is being developed in collaboration with Cleveland Clinic.

The vaccine targets alpha-lactalbumin, a lactation-associated protein normally expressed in breast tissue during lactation but which re-emerges in several forms of breast cancer. The approach is designed to stimulate an immune response against cells expressing the protein, with potential therapeutic and preventive applications.

The candidate is based on preclinical research led by the late Vincent Tuohy, former Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic.

Anixa said final Phase 1 results showed the 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.

Amit Kumar, chairman and chief executive officer of Anixa Biosciences, said: “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.”

He added: “Cytovance’s expertise in cGMP biologics production provides us with the technical strength and reliability necessary to support our next phase of clinical development.”

Cytovance Biologics will provide contract development and manufacturing services to produce clinical-grade material for the upcoming trial. The company specialises in mammalian and microbial biologics manufacturing and will support scale-up and production under regulatory standards required for clinical development.

Ping Zhang, chief executive officer of Cytovance Biologics, said: “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.”

The Phase 1 study results provide early clinical evidence supporting both safety and immunogenicity, with Anixa now preparing for expansion into a larger Phase 2 trial.

The programme reflects growing interest in cancer vaccines targeting tumour-associated antigens, particularly in breast cancer, where preventative and immune-based strategies remain an active area of research.

Further updates on Phase 2 trial initiation are expected as manufacturing and regulatory preparation progresses.