Summary of Anixa Biosciences Conference Call Company Overview - **Company**: Anixa Biosciences (NasdaqCM: ANIX) - **Industry**: Biotechnology - **Focus**: Clinical stage biotech company with two early-stage clinical developments: a CAR T cell therapy for ovarian cancer and a breast cancer vaccine program [1][2] Key Points and Arguments Breast Cancer Vaccine Program - The breast cancer vaccine program is designed as both a treatment and prophylactic, focusing on a novel approach targeting a protein expressed only during lactation, which is produced by cancer cells in some breast cancer patients [6][7][8] - The phase one study presented at the 2025 San Antonio Breast Cancer Symposium showed promising results, with the data exceeding expectations and being superior to other cancer vaccines in phase one trials [9][10] Phase One Study Results - The phase one trial involved three cohorts of women: 1. Women with a history of triple-negative breast cancer at high risk of recurrence 2. Women with BRCA mutations who opted for prophylactic mastectomies 3. Women with residual disease post-treatment [10][12][13] - Key findings: - The vaccine was found to be safe with no significant side effects, only mild injection site irritation [11][18] - Strong immune responses were observed in 75% of participants [11][20] - No significant differences in immune response rates among the cohorts [21] Future Clinical Trials - Plans for a phase two study in a neoadjuvant setting, where newly diagnosed breast cancer patients will receive the vaccine alongside standard care (Keytruda) [24][25] - The trial is expected to enroll 80 to 100 women and take approximately two to three years to complete, with data available much sooner [29][31] - The goal is to demonstrate the vaccine's efficacy in reducing tumor burden before surgery, potentially leading to better outcomes and lower recurrence rates [25][27] Corporate Strategy and Partnerships - Anixa aims to establish pharmaceutical partnerships to fund further trials and commercialize the vaccine, reducing reliance on capital markets [28] - The IND has been transferred from Cleveland Clinic to Anixa, allowing the company to sponsor the trial [32] Broader Research Initiatives - Anixa is also advancing preclinical and R&D vaccine programs targeting other cancers, including ovarian, prostate, lung, and colon cancers, with a focus on identifying unique proteins associated with these cancers [34][35] Additional Important Insights - The approach of targeting unique proteins on cancer cells aims to avoid autoimmune responses, which is a significant advantage over traditional cancer vaccine strategies [7][35] - The company is optimistic about the potential for the breast cancer vaccine findings to be replicated in other cancer types, indicating a broader application of their research strategy [34][35]