Anixa Biosciences Moves Breast Cancer Vaccine Forward: IND Sponsorship Transfer Marks Key Development Milestone

Anixa Biosciences (NASDAQ: ANIX) just leveled up in its cancer vaccine game. The biotech firm has officially taken over sponsorship of the Investigational New Drug (IND) application for its breast cancer vaccine from Cleveland Clinic—a move that signals serious progress in the candidate’s clinical journey.

What’s Actually Happening Here?

Let’s break it down: Anixa Biosciences completed enrollment in its Phase 1 trial with solid immune response and safety data in hand. Now the company is ready to push into Phase 2. Taking over IND sponsorship isn’t bureaucratic busy work—it’s the natural next step that means Anixa Biosciences is confident enough to run the show independently, while still partnering with Cleveland Clinic and other clinical sites for the upcoming trials.

The Science Behind the Vaccine

Here’s where it gets interesting. The vaccine targets α-lactalbumin, a protein that normally appears in breast tissue only during lactation. Problem is, this same protein pops back up in many breast cancer forms. By training the immune system to recognize and attack α-lactalbumin-expressing cells, Anixa Biosciences’ vaccine could potentially work both ways—treating existing tumors and preventing cancer in high-risk individuals.

This technology came from preclinical research by the late Vincent Tuohy, Ph.D., who held the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic.

Beyond Breast Cancer

Anixa Biosciences isn’t putting all eggs in one basket. The company’s pipeline also includes an ovarian cancer immunotherapy developed with Moffitt Cancer Center using CER-T (chimeric endocrine receptor-T cell) technology. Unlike traditional CAR-T approaches, CER-T uses FSH—the natural ligand—to bind to FSHR receptors on tumor cells rather than relying on antibody fragments.

The vaccine portfolio extends further, with programs targeting lung, colon, and prostate cancers, all built on the concept of immunizing against “retired” proteins expressed in specific cancer types.

Why This Matters

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, emphasized the significance: “We’re excited to assume sponsorship of the breast cancer vaccine IND and advance this potentially transformative cancer vaccine into future clinical trials.”

Data from Phase 1 were already shared at the San Antonio Breast Cancer Symposium in December, generating industry interest. Moving into Phase 2 with multiple clinical sites means accelerated development—and that’s the kind of biotech momentum that catches attention.