Anixa Biosciences Initiates Transfer of Breast Cancer Vaccine IND to Phase 2 Trial.

Anixa Biosciences has initiated the transfer of the IND for its breast cancer vaccine to a Phase 2 clinical trial after observing positive immune response data in a completed Phase 1 trial. The company plans to assume full sponsorship of the IND and has engaged Advyzom as its U.S. regulatory agent. The Phase 2 trial aims to advance the vaccine's development for cancer treatment and prevention.

Anixa Biosciences (NASDAQ: ANIX) has taken a significant step forward in its breast cancer vaccine development by initiating the transfer of the Investigational New Drug (IND) application from Cleveland Clinic to support an upcoming Phase 2 clinical trial. This move follows positive immune response data from a completed Phase 1 trial, where over 70% of patients demonstrated protocol-defined immune responses [1][2][3].

The company plans to assume full sponsorship of the IND and has engaged Advyzom as its U.S. regulatory agent to manage FDA interactions during this process. The Phase 2 trial aims to further validate the vaccine's efficacy and safety, moving it closer to potential commercialization. The vaccine targets α-lactalbumin, a protein that is normally expressed during lactation but also appears in many breast cancer cells, offering both therapeutic and preventive benefits [1][2].

Anixa's breast cancer vaccine, developed in collaboration with Cleveland Clinic, has shown promising results in early-stage trials. The company's strategic partnership with Cleveland Clinic and the engagement of Advyzom indicate a methodical approach to advancing the vaccine through clinical development. This progress is a notable milestone for Anixa, signaling confidence in the program's potential and its ability to navigate complex regulatory interactions [1][2].

For biotechnology investors, this news represents tangible progress in Anixa's clinical pipeline. While several years of additional clinical development are still required, the company's systematic advancement towards potential commercialization is encouraging. The vaccine's unique mechanism, targeting a protein specifically expressed in breast cancer cells, distinguishes it from other cancer vaccines [1][2].

References:
[1] https://www.stocktitan.net/news/ANIX/anixa-biosciences-announces-commencement-of-us-fda-approved-ind-bc38el8hhp64.html
[2] https://www.streetinsider.com/Press+Releases/Anixa+Biosciences+Announces+Commencement+of+US+FDA+Approved+IND+Transfer+to+Support+Upcoming+Phase+2+Breast+Cancer+Vaccine+Trial/25140366.html
[3] https://www.marketscreener.com/news/anixa-biosciences-announces-commencement-of-us-fda-approved-ind-transfer-to-support-upcoming-phase-2-ce7c5edadf8bff21