Anixa Biosciences announced that the U.S. Food and Drug Administration approved a protocol amendment for its Phase 1 ovarian cancer CAR‑T study, allowing the dose to be increased from the original 1 × 10⁵–1 × 10⁷ cells per kilogram to as high as 1 × 10⁹ cells per kilogram. The amendment, approved by the Institutional Review Board at Moffitt Cancer Center, removes a regulatory barrier and expands the therapeutic window for the company’s CER‑T platform.
Safety data from the first 12 patients treated at four dose levels showed no dose‑limiting toxicities. Several patients exceeded expected median survival, with one patient living 28 months and others surviving 17, 15, and 14 months. The absence of toxicity at lower doses gives the investigators confidence to explore higher doses and to add lymphodepletion, an investigational strategy intended to enhance CAR‑T efficacy in solid tumors.
The ability to test higher doses is a critical step for Anixa, as it allows the company to map the full dose‑response curve and to generate robust data that could support a future FDA approval and commercial launch. A successful dose‑escalation program also strengthens the company’s position when negotiating partnerships or licensing agreements with larger biopharmaceutical firms, as it demonstrates both safety and early signs of clinical activity in a difficult‑to‑treat indication.
Anixa’s balance sheet remains solid, with cash reserves that provide runway for continued clinical development. While the company has yet to generate revenue, the positive clinical milestone is expected to enhance investor confidence and could improve the company’s ability to secure additional funding or strategic collaborations. The company’s breast‑cancer vaccine program, in collaboration with the Cleveland Clinic, also remains on track, adding diversification to its pipeline.
Dr. Amit Kumar, CEO, said, “The data from the first 12 patients are encouraging. The absence of dose‑limiting toxicities at these early dose levels gives us confidence to move forward with higher doses and to explore lymphodepletion.” Dr. Robert Wenham, principal investigator at Moffitt, added, “The safety profile observed so far has allowed us to safely expand the dose range, which is essential for determining the optimal therapeutic window.”
Investors reacted positively to the announcement, citing the regulatory approval and encouraging survival data as key drivers of the market’s favorable response. The FDA approval removes a major regulatory hurdle, while the early safety and survival signals suggest that the therapy may achieve meaningful clinical benefit at higher doses, thereby increasing the likelihood of future regulatory approval and partnership opportunities.
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