Anixa Biosciences(ANIX) Prnewswire·2024-09-24 12:30Strategic Plan for Phase 2 Study - The company announced its strategic plan for a Phase 2 study of its breast cancer vaccine, which will evaluate the vaccine's efficacy in combination with chemotherapy and Keytruda (pembrolizumab) in the neoadjuvant setting [1][2] - The Phase 2 trial aims to reduce tumor burden, prevent recurrence, and improve survival, while enrolling a broader range of patients with multiple types of breast cancer [2] - The trial is expected to commence in 2025 and last approximately two to three years, with immunological responses to the vaccine being made available as the trial progresses [3] Market and Therapeutic Approach - The therapeutic market for breast cancer is large, valued at approximately 89.67 billion by 2030, growing at a CAGR of 12.9% [2] - The development path for breast cancer treatment is expected to have a shorter path to approval compared to primary prevention, covering all stages of breast cancer from early to advanced and metastatic cases [2] - The company's approach focuses on targeting treatment rather than prevention, which allows for a broader patient population and potentially expedites regulatory approval and partnerships [4] Vaccine Technology and Mechanism - The breast cancer vaccine targets endogenously produced proteins, such as α-lactalbumin, which are present in certain breast cancers but not in normal, aging tissues [6] - The vaccine activates the immune system against these "retired" proteins, providing preemptive immune protection against emerging breast tumors that express α-lactalbumin [6] - The vaccine also contains an adjuvant that activates an innate immune response, enabling the immune system to mount a response against emerging tumors to prevent their growth [6] Collaboration and Funding - The Phase 1 trial is conducted in collaboration with Cleveland Clinic and funded by a grant from the U S Department of Defense [5] - The company is the exclusive worldwide licensee of the novel breast cancer vaccine technology developed at Cleveland Clinic [5][7] - The late Dr Vincent Tuohy, who invented the vaccine technology, was entitled to a portion of the commercialization revenues received by Cleveland Clinic and held equity in the company [7][8] Company Overview and Portfolio - The company is a clinical-stage biotechnology company focused on the treatment and prevention of cancer, with a therapeutic portfolio including an ovarian cancer immunotherapy program and a vaccine portfolio targeting breast and ovarian cancers [9] - The company's vaccine technologies focus on immunizing against "retired" proteins expressed in certain forms of cancer, including triple-negative breast cancer (TNBC), lung, colon, and prostate cancers [9] - The company's business model involves partnering with world-renowned research institutions for development and commercialization of emerging technologies in complementary fields [9]