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Founded
1982
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- IP Australia issued a Notice of Acceptance for Anixa Biosciences' breast cancer vaccine patent, the first Australian patent covering the company's vaccine platform. - The patent, exclusively licensed from Cleveland Clinic, covers immunizing against human alpha-lactalbumin, a protein aberrantly expressed in certain breast cancers. - The acceptance complements existing patents in the United States, Europe, China, Japan and South Korea, where protection runs through 2040. - The vaccine met all major primary endpoints in a completed Phase 1 trial, generating protocol-defined immune responses in more than 74% of participants.
- Anixa Biosciences' breast cancer vaccine met all primary endpoints in Phase 1, demonstrating safety and tolerability at the maximum tolerated dose. - The investigational vaccine generated protocol-defined immune responses in 74% of participants, supporting advancement to Phase 2 clinical trials. - The company has partnered with Cytovance Biologics for cGMP manufacturing of clinical materials needed for the upcoming Phase 2 study. - The vaccine targets α-lactalbumin, a lactation-associated protein that re-emerges in many forms of breast cancer, offering potential therapeutic and preventive benefits.
- The Cancer Vaccine Coalition and American Association for Cancer Research convened over 50 leading cancer vaccine researchers for a first-of-its-kind global think tank to coordinate progress in cancer immunity. - Current immunotherapies successfully treat only 20% of the deadliest cancers, while therapeutic cancer vaccines have the potential to expand success to the remaining 80% by creating cancer-killing T cells. - Clinical trials are currently underway across multiple cancer types including glioblastoma, melanoma, pancreatic, breast, ovarian, and liver cancers, showing promising signals of immune response and clinical benefit. - The initiative aims to align scientific priorities, improve research efficiency, integrate emerging technologies like AI-driven antigen prediction, and establish models for sustained global collaboration.
- Anixa Biosciences reported positive final Phase 1 clinical trial results for its investigational α-lactalbumin breast cancer vaccine, showing protocol-defined immune responses in 74% of participants. - The trial, conducted with Cleveland Clinic and funded by the U.S. Department of Defense, enrolled 35 participants across three cohorts and demonstrated the vaccine was safe and well-tolerated at the maximum tolerated dose. - The company plans to advance to Phase 2 studies, including a potential combination trial with Keytruda in the neoadjuvant setting for newly diagnosed breast cancer patients. - Following the announcement at the 2025 San Antonio Breast Cancer Symposium, Anixa's stock surged 15.21% in after-hours trading to $5.53.
- Anixa Biosciences' investigational alpha-lactalbumin breast cancer vaccine met all major primary endpoints in Phase 1 trials, demonstrating safety and tolerability at maximum tolerated dose. - The vaccine elicited protocol-defined immune responses in 74% of participants across three cohorts, including women with triple-negative breast cancer and BRCA mutation carriers. - Combination therapy with Keytruda showed no major additional side effects and generated antigen-specific T cell responses, supporting plans for Phase 2 neoadjuvant studies. - Results were presented at the 2025 San Antonio Breast Cancer Symposium, with the vaccine targeting alpha-lactalbumin protein expressed in many breast cancers.
- Cleveland Clinic researchers presented final Phase 1 results for an investigational vaccine targeting triple-negative breast cancer, showing a 74% immune response rate across 35 participants. - The vaccine targets α-lactalbumin protein found in 70% of triple-negative breast cancers and was deemed safe with only mild injection site reactions reported. - A Phase 2 efficacy trial is planned for late 2025 to evaluate whether the immune response translates into reduced recurrence risk for this aggressive cancer type. - Triple-negative breast cancer represents 10-15% of cases but causes disproportionate deaths, particularly affecting Black women and BRCA1 mutation carriers.
- The World Health Organization's International Nonproprietary Names Expert Committee approved "liraltagene autoleucel" as the official name for Anixa Biosciences' FSHR-targeted CAR-T therapy for recurrent ovarian cancer. - The therapy represents a novel CER-T (chimeric endocrine receptor-T cell) technology that uses the natural FSH ligand instead of antibody fragments to target the FSHR receptor on tumor cells. - Anixa is currently conducting a Phase 1 first-in-human trial in partnership with Moffitt Cancer Center, with plans to commence the 5th dose cohort in the coming weeks. - The INN approval marks a significant regulatory milestone toward potential global commercialization of this innovative immunotherapy approach for ovarian cancer treatment.
- Anixa Biosciences has entered into a letter of intent with Austria-based VERDI Solutions to develop both personalized and off-the-shelf peptide vaccines for cancer patients. - VERDI's technology integrates artificial intelligence and cloud computing to accelerate vaccine development, with three patients already receiving personalized vaccines for bone metastases in Europe. - The six-month exclusive negotiation agreement aims to advance VERDI's cancer vaccines to clinical trials in the United States while continuing individual treatment attempts in Europe.
- Anixa Biosciences will present Phase 1 clinical trial data on its innovative ovarian cancer CAR-T therapy at the 2025 ASCO Annual Meeting in Chicago, featuring a unique chimeric endocrine receptor-T cell technology. - The company's novel approach targets the follicle-stimulating hormone receptor (FSHR) on ovarian cancer cells, differentiating it from traditional CAR-T therapies by utilizing the natural ligand FSH rather than antibody fragments. - Dr. Robert Wenham from Moffitt Cancer Center, the principal investigator, will lead the presentation, highlighting Anixa's strategic collaborations with premier research institutions to advance next-generation immunotherapies for solid tumors.
- Anixa Biosciences and Moffitt Cancer Center receive approval for protocol amendment allowing second CAR-T doses in their ovarian cancer clinical trial, enhancing potential treatment benefits. - The amended protocol expands patient eligibility to include rare ovarian cancer types such as sex cord-stromal tumors and Sertoli Leydig cell tumors. - This development eliminates the need for individual IND approvals for second doses, streamlining the process for patients showing potential benefit from additional treatment.
