Anixa Biosciences Assumes Full Control of Breast Cancer Vaccine Trial

Anixa Biosciences has taken a decisive step forward in the development of its breast cancer vaccine. The company has assumed full sponsorship of the Investigational New Drug (IND) application from the Cleveland Clinic, paving the way for the imminent initiation of a Phase 2 clinical study. This strategic move follows encouraging Phase 1 trial results, even as the company's share price exhibits significant volatility.

Despite the positive clinical developments, Anixa's stock has experienced notable price swings, a common occurrence in the biotechnology sector. The shares are currently trading at €2.94, reflecting a decline of approximately 33% over the past seven trading days. Such fluctuations often stem from a mix of profit-taking, investor uncertainty regarding future funding or regulatory pathways, and reactions to near-term catalysts.

The key catalyst now in focus is the official launch of the Phase 2 trial. For investors, two critical factors will be the specific design of the Phase 2 protocol—including patient population, primary endpoints, and potential drug combinations—and the timeline for patient recruitment. Clear progress on these fronts could help stabilize the share price, while lingering uncertainties may prolong the period of heightened volatility.

Significance of the IND Sponsorship Transfer

The transfer of the IND sponsorship to Anixa marks a shift toward greater operational independence. The company is now the sole sponsor responsible for the trial's design, execution, and timeline management for the next clinical phase. This control allows Anixa to centrally coordinate the multi-site Phase 2 study, which will still involve the Cleveland Clinic among other investigative centers. The transition underscores the program's high priority within the company's pipeline.

Should investors sell immediately? Or is it worth buying Anixa Biosciences?

The vaccine candidate targets α-lactalbumin, a protein that reappears in a majority of breast cancer tumors. The therapeutic goal is to train the immune system to identify and destroy cells expressing this marker, offering a potential treatment and preventive strategy.

Phase 1 Results and Future Plans

Recently presented final data from the Phase 1 study met all primary endpoints, according to the company. At the maximum tolerated dose, no serious safety concerns were identified, and the vaccine was well-tolerated. A protocol-defined immune response was detected in 74% of the participants.

As planning for the Phase 2 trial advances, Anixa is evaluating a potential combination therapy approach. The company is investigating pairing its vaccine with the checkpoint inhibitor Keytruda (pembrolizumab) for newly diagnosed patients.

Key Data Summary:
* Clinical Data: Phase 1 trial successfully met all primary endpoints, demonstrating an immune response in 74% of participants.
* Operational Update: IND sponsorship transfer from the Cleveland Clinic is complete; Anixa is now the sole trial sponsor.
* Next Steps: Phase 2 study is planned for multiple sites, with a potential Keytruda combination under review.
* Market Data: Current share price is €2.94, down roughly one-third over the last week.