Anixa Biosciences Announces Positive Phase 1 Data for Investigational Breast Cancer Vaccine; Primary Endpoints Were Met and Immune Response Observed in 74% of Participants

Core Insights - Anixa Biosciences, Inc. announced positive final data from its Phase 1 clinical trial of an investigational breast cancer vaccine, indicating safety and immune response efficacy, supporting advancement to Phase 2 development [1][2][12] Group 1: Clinical Trial Results - The Phase 1 trial met all major primary endpoints, demonstrating safety and tolerability at the maximum tolerated dose (MTD), with 74% of participants showing protocol-defined immune responses [2][8] - The investigational vaccine, targeting alpha-lactalbumin (aLA), was well tolerated with minimal adverse effects, primarily injection-site irritation [6][9] - Participants will be followed for five years post-study to assess long-term outcomes [8] Group 2: Cohort Details - The trial included 35 participants across three cohorts, focusing on women at elevated risk of recurrence, those with BRCA mutations, and women receiving pembrolizumab (Keytruda) [5][10] - In Cohort Ia, the vaccine was safe with no flu-like symptoms reported, while Cohort Ib showed similar safety profiles [6][7] - Cohort Ic aimed to evaluate the combination of the vaccine with pembrolizumab, reporting no major adverse side effects [9] Group 3: Future Development Plans - The results support plans for a Phase 2 neoadjuvant combination study with Keytruda in newly diagnosed breast cancer patients [1][8] - Ongoing analyses of immunohistochemistry in resected breast tissue will provide further insights into the vaccine's efficacy [7][8] - The company aims to engage with regulators to advance the vaccine's development following the promising Phase 1 results [12]