Biotechnology company Anixa Biosciences has partnered with Cytovance Biologics to support the Phase II clinical trial of a breast cancer vaccine. 

The 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 tumours expressing this protein.  

Phase I 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 programme into a Phase II clinical trial. 

“Selecting Cytovance for cGMP manufacturing marks a critical step as we prepare to advance our breast cancer vaccine into Phase II,” said Dr Amit Kumar, Chairman and CEO of Anixa Biosciences. 

“Our Phase I 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.” 

“We are pleased to partner with Anixa to manufacture clinical materials for its Phase II breast cancer vaccine trial,” added Ping Zhang, CEO of Cytovance Biologics.  

“Our team is committed to delivering high-quality cGMP manufacturing solutions that support innovative biotech programmes. We look forward to leveraging our development and production capabilities to help advance this promising immunotherapy candidate.”