Anixa Biosciences Inc. (ANIX) had a pretty great Thursday evening, with shares jumping 15.21% to $5.53 in after-hours trading. The catalyst? Final Phase 1 clinical trial data for the company's investigational breast cancer vaccine that showed some genuinely encouraging results.
What the Trial Showed
The healthcare company presented its final data Thursday at the 2025 San Antonio Breast Cancer Symposium. This trial was conducted in partnership with the Cleveland Clinic and funded by a U.S. Department of Defense grant, which is always a good sign when you're trying to develop something ambitious like a cancer vaccine.
The headline number: protocol-defined immune responses occurred in 74% of participants. That's the kind of figure that gets investors excited, especially when paired with safety data showing the vaccine was well-tolerated at the maximum tolerated dose.
Dr. G. Thomas Budd, the principal investigator at the Cleveland Clinic, summed it up well: "The investigational α-lactalbumin vaccine was safe and well tolerated at the maximum tolerated dose and generated protocol-defined immune responses in 74% of participants—results that support continued clinical evaluation."
The trial enrolled 35 participants across three cohorts, and the vaccine hit all major primary endpoints. For a Phase 1 trial, which is primarily designed to test safety rather than efficacy, these results represent a solid foundation for moving forward.
Where Things Go From Here
Anixa isn't resting on these results. The company noted that the Phase 1 data will inform its planned Phase 2 study design, including a potential combination trial with Keytruda in the neoadjuvant setting for newly diagnosed breast cancer patients. Combining investigational vaccines with established immunotherapy drugs like Keytruda is a common strategy in oncology these days.
Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "We look forward to engaging with regulators and advancing plans for a Phase 2 study."
The Numbers Behind the Stock
The California-based biotech has had quite a year. The stock has gained 106.90% year to date, though it closed regular trading on Thursday at $4.80, down 6.43% for the day before the after-hours surge.
Anixa currently has a market capitalization of $158 million, with a 52-week range spanning from $2.07 to $5.46. That's the kind of volatility you'd expect from a clinical-stage biotech company where everything hinges on trial results and regulatory decisions.
For context, the after-hours price of $5.53 puts the stock near the top of that 52-week range, suggesting investors are betting that these Phase 1 results could translate into something meaningful down the line.