A potential breakthrough in breast cancer prevention and treatment is emerging from a joint effort by Anixa Biosciences and the Cleveland Clinic. Their experimental vaccine targets α-lactalbumin (α-LA), a milk protein normally produced only during lactation but re-expressed in up to 70% of triple-negative breast cancer (TNBC) cases—one of the most aggressive and treatment-resistant breast cancer subtypes.
The vaccine works by training the immune system to recognize α-LA as a foreign protein, prompting an immune attack on cancer cells that express it while sparing healthy tissue.
Phase I Success
In a Phase I trial involving 35 women—either with early-stage TNBC or at high genetic risk—over 75% developed a strong immune response, producing antibodies and activating white blood cells against α-LA. The vaccine was well tolerated, with only mild injection-site irritation reported and no serious systemic side effects, even in patients receiving it alongside pembrolizumab, a standard cancer immunotherapy.
These results mirror earlier animal studies, where α-LA vaccination completely prevented breast tumors in mice.
Moving to Phase II
Anixa Biosciences has received FDA clearance to lead the Phase II trial, expected to launch in 2025–2026. The next stage will enroll a larger, more diverse patient group and may expand testing to other breast cancer types. Researchers aim to evaluate the vaccine in a neoadjuvant setting, given before surgery in newly diagnosed patients.
Why It Matters
If successful, the α-LA vaccine could fill a major treatment gap for TNBC, which currently lacks targeted hormone-based therapies. With its high immune activation, minimal side effects, and targeted approach, the vaccine represents a promising new frontier in breast cancer prevention and treatment.
