Anixa Biosciences (ANIX) investor relations material

Program overview and scientific approach

• Focus on a novel breast cancer vaccine targeting a protein expressed only during lactation, aiming to avoid autoimmune side effects seen in previous cancer vaccine attempts.

• The vaccine targets alpha-lactalbumin, present only in cancer cells and not in healthy tissue, enabling early immune intervention.

• Phase I study included three cohorts: high-risk post-surgery patients, women with genetic predisposition pre-surgery, and patients with residual disease post-treatment.

• The approach is based on the retired protein hypothesis, aiming for both treatment and prophylactic use.

Phase I results and safety profile

• Phase I data showed strong safety, with no systemic side effects and only injection site irritation reported.

• Achieved maximum tolerated dose and robust immune responses in 75% of participants, with the remainder showing modest responses.

• Immune responses included activation of both T cells and B cells targeting the cancer-specific protein.

• No significant differences in immune response rates among the three cohorts.

• Combination with Keytruda did not result in additional systemic side effects, supporting future combination studies.

Insights and implications for phase II

• The high immune response rate exceeded expectations and supports advancing to phase II.

• Phase II will be an open-label trial in the neoadjuvant setting, comparing standard of care (Keytruda) versus Keytruda plus vaccine.

• The trial will enroll 80-100 women and is expected to last 2-3 years, with interim data available earlier.

• Early demonstration of efficacy could facilitate pharmaceutical partnerships and commercialization.

• Plans to submit necessary reports and meet with the FDA early next year, aiming to start phase II within the year.