Final Clinical Visit Marks Major Milestone in First-in-Human Evaluation of Breast Cancer Vaccine Comprehensive Immune Response and Safety Data to Be Presented at the San Antonio Breast Cancer Symposium in December , /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the completion of the final patient visit in its breast cancer vaccine clinical trial. This novel vaccine, invented at Cle ...

Core Insights - Anixa Biosciences has initiated the transfer of the Investigational New Drug (IND) application for its breast cancer vaccine, which is currently held by Cleveland Clinic, to advance to a Phase 2 clinical trial [1][2][4] - The Phase 1 clinical trial has shown promising results, with over 70% of patients exhibiting immune responses, indicating the vaccine's potential effectiveness [2][4] - The breast cancer vaccine targets α-lactalbumin, a protein associated with lactation that re-emerges in many breast cancer forms, suggesting both therapeutic and preventive benefits [3][4] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [5] - The company is developing vaccines for breast and ovarian cancer, as well as other cancers, utilizing technologies that target proteins expressed in certain cancer forms [5] - Anixa's business model involves partnerships with leading research institutions to explore and commercialize emerging technologies in cancer treatment [5]

"This newly allowed patent further illustrates the international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue advancing clinical development in the U.S., this allowance further strengthens our ability to pursue strategic global opportunities in regions with a high burden of breast cancer." Breast cancer remains the most commonly diagnosed cancer in women globally and a leading cause of cancer- related de ...

Core Viewpoint - Anixa Biosciences has received a patent for its breast cancer vaccine technology, which addresses a significant unmet need in preventive oncology and has the potential for a multi-billion dollar market opportunity [1][2][5]. Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes a breast cancer vaccine developed in collaboration with Cleveland Clinic [7]. - The company has a unique business model of partnering with renowned research institutions for all stages of development, allowing for continuous examination of emerging technologies [7]. Patent and Technology - The U.S. Patent Number 12,370,244 will be issued on July 29, 2025, covering methods of immunizing patients against breast cancer using human α-lactalbumin protein [1][2]. - The patent extends foundational protection for the breast cancer vaccine program into the mid-2040s, enhancing Anixa's ability to develop and commercialize immunopreventive solutions [2][6]. Market Opportunity - The breast cancer vaccine platform represents a potential multi-billion dollar market, particularly for women at elevated risk of developing triple-negative breast cancer (TNBC) [5]. - In the U.S., over 297,000 new cases of invasive breast cancer are projected in 2025, highlighting the significant need for preventive solutions [3]. Vaccine Mechanism - The investigational vaccine aims to stimulate the immune system to recognize and eliminate pre-malignant and malignant cells expressing α-lactalbumin while sparing normal tissue [4]. - By targeting this protein, which is generally absent from adult tissues except during lactation, the vaccine may minimize off-target effects and provide long-lasting immune protection [4].

Core Viewpoint - Anixa Biosciences has announced the issuance of a key patent for its ovarian cancer vaccine technology, which is expected to enhance the company's position in the cancer treatment market [1][4]. Group 1: Patent and Technology - The United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,357,593 on July 15, 2025, covering methods related to eliciting an immune response targeting anti-Müllerian hormone receptor, type II (AMHR2) [1]. - The patent includes methods for administering an immunogenic composition that encodes the AMHR2 polypeptide, specifically targeting the extracellular domain of human AMHR2 [3]. - Anixa holds exclusive worldwide rights to the patent, which was issued to Cleveland Clinic [3]. Group 2: Collaboration and Development - The ovarian cancer vaccine is being developed in collaboration with Cleveland Clinic and the National Cancer Institute, focusing on high-risk populations such as those with BRCA mutations [2]. - Anixa's therapeutic portfolio includes an ovarian cancer immunotherapy program utilizing chimeric endocrine receptor-T cell (CER-T) technology, which is distinct from traditional CAR-T therapies [4]. - The company is also developing additional cancer vaccines in collaboration with Cleveland Clinic to address various cancers, including breast, lung, colon, and prostate cancers [4].

Core Insights - Anixa Biosciences, Inc. is advancing a breast cancer vaccine that aims to train the immune system to identify and eliminate cancerous cells before they develop into invasive tumors [2][3] - The vaccine specifically targets α-lactalbumin, a protein expressed in the breast during lactation, which is also found in malignant breast cancer cells [2] - The company has completed enrollment in the Phase 1 clinical trial for the vaccine and is optimistic about its potential impact on breast cancer treatment and prevention [3] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [4] - The company utilizes a unique CAR-T technology known as chimeric endocrine receptor-T cell (CER-T) technology, which differentiates itself by targeting the natural ligand of the FSHR receptor on tumor cells [4] - Anixa's vaccine portfolio includes collaborations with Cleveland Clinic to develop vaccines for breast and ovarian cancer, as well as other cancers such as lung, colon, and prostate [4]

Financial Data and Key Metrics Changes - The company has a strong balance sheet with $17 million in cash, providing a runway of approximately 2.5 years, which is considered ample in the current industry context [6][9][13] - Historical cash burn averages between $5 million and $7 million per year, indicating a capital-efficient business model [8][15] Business Line Data and Key Metrics Changes - The company is advancing two lead clinical programs: a breast cancer vaccine and an ovarian cancer CAR T therapy, both currently in Phase 1 clinical trials with promising clinical data [3][16] - The breast cancer vaccine is funded by a U.S. Government grant, which helps keep cash burn low [17][34] Market Data and Key Metrics Changes - The breast cancer market is large and well-known, while the ovarian cancer market, though smaller, presents a significant unmet medical need with poor outcomes [5] - The company is targeting both neoadjuvant and primary prevention markets for its breast cancer vaccine, indicating a broad market strategy [40] Company Strategy and Development Direction - The company leverages partnerships with top-tier academic institutions like Moffitt Cancer Center and Cleveland Clinic to enhance its research capabilities without incurring high costs [4][10] - The strategy focuses on advancing clinical programs through early stages and partnering with pharmaceutical companies for later-stage development and commercialization [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data being generated, particularly regarding the safety and efficacy of the ovarian cancer CAR T therapy, with encouraging survival rates observed in treated patients [27][28] - The company aims to present final data from the Phase 1 trial of the breast cancer vaccine at the San Antonio Breast Cancer Symposium in December, indicating a proactive approach to sharing results [39] Other Important Information - The company has maintained consistent insider buying over the years, reflecting management's confidence in the business [7] - There are no outstanding warrants, preferred stock, or debt, which positions the company favorably for future financing [13] Q&A Session Summary Question: What is the current status of the ovarian cancer CAR T therapy? - The therapy is in Phase 1 trials, with encouraging safety profiles and overall survival rates observed in treated patients [27][28] Question: How is the breast cancer vaccine funded? - The breast cancer vaccine is fully funded by a U.S. Government grant, which helps minimize cash burn [17][34] Question: What are the next steps for the breast cancer vaccine program? - The company plans to present final data from the Phase 1 trial at the San Antonio Breast Cancer Symposium in December and is preparing for a Phase 2 trial [39][40]

Core Points - Anixa Biosciences has received a Notice of Allowance for a new patent related to its breast cancer vaccine technology, which broadens the scope of immunogenic compositions used in the vaccine [1][2] - The patent covers methods of immunizing patients against breast cancer using an immunogenic composition containing the human α-lactalbumin protein, which is expressed in certain breast cancers [2] - The CEO of Anixa highlighted that this patent enhances the company's intellectual property portfolio, which includes multiple issued and pending patents in the U.S. and internationally [3] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [3] - The company's vaccine portfolio includes vaccines for breast and ovarian cancer, as well as other cancer vaccines targeting high incidence malignancies such as lung, colon, and prostate cancers [3] - Anixa's business model involves partnerships with renowned research institutions, allowing the company to explore emerging technologies for further development and commercialization [3]