Anixa Biosciences Initiates Transfer of Breast Cancer Vaccine IND Application, Plans Phase 2 Trial

Anixa Biosciences has initiated the transfer of the IND application for its breast cancer vaccine, following positive immune response data in its Phase 1 clinical trial. The company plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND. Anixa has engaged Advyzom as its U.S. regulatory agent to oversee the transfer process. The vaccine targets α-lactalbumin, a protein expressed in breast tissue during lactation and re-emerges in many forms of breast cancer.

Anixa Biosciences (NASDAQ: ANIX) has initiated the transfer of the Investigational New Drug (IND) application for its breast cancer vaccine from Cleveland Clinic, signaling a significant milestone in its clinical development pipeline. The company plans to advance the vaccine into a Phase 2 clinical trial, with full sponsorship of the IND application. Anixa has engaged Advyzom as its U.S. regulatory agent to oversee the transfer process [1].

The breast cancer vaccine targets α-lactalbumin, a protein normally expressed during lactation but also found in many breast cancers. The vaccine has shown promising results in Phase 1 trials, with over 70% of patients demonstrating protocol-defined immune responses [1]. This level of immunogenicity is encouraging and suggests the vaccine is biologically active. The vaccine was also well-tolerated, which is crucial at this stage of development.

The transfer of the IND application from Cleveland Clinic to Anixa indicates confidence in the program's potential and a transition to sponsor-led development. The preliminary Phase 1 results are particularly noteworthy, with 70% of patients exhibiting protocol-defined immune responses [1]. This suggests the vaccine is biologically active and may offer both therapeutic and preventive benefits by targeting α-lactalbumin, a relatively specific target that may minimize off-target effects.

The engagement of Advyzom as regulatory consultant suggests Anixa is preparing for more complex regulatory interactions that typically accompany Phase 2 studies. This trial progression also indicates that Cleveland Clinic, a prestigious research institution, has generated sufficient data to warrant continued development - an important external validation of the technology.

For biotechnology investors, this news represents tangible progress in Anixa's clinical pipeline and suggests the company is methodically advancing toward potential commercialization, though several years of additional clinical development would still be required.

References:
[1] https://www.stocktitan.net/news/ANIX/anixa-biosciences-announces-commencement-of-us-fda-approved-ind-bc38el8hhp64.html
[2] https://www.yahoo.com/news/articles/really-breast-cancer-vaccine-175157022.html