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]

Core Insights - Anixa Biosciences has completed the transfer of the Investigational New Drug application for its breast cancer vaccine from Cleveland Clinic, becoming the trial sponsor for its future development [1][2] - The company plans to advance the vaccine into a Phase 2 clinical trial after completing enrollment and observing encouraging immune response and safety data in the Phase 1 trial [2][4] - The breast cancer vaccine targets -lactalbumin, a protein that re-emerges in many forms of breast cancer, potentially offering therapeutic and preventive benefits [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 [5] - The company’s vaccine portfolio includes vaccines for breast and ovarian cancer, developed in collaboration with Cleveland Clinic, and aims to address various cancers by immunizing against "retired" proteins expressed in certain cancer forms [5] - Anixa's business model involves partnering with renowned research institutions to explore emerging technologies for further development and commercialization [5]

Core Insights - Anixa Biosciences is a clinical stage biotech company focused on developing innovative CAR-T cell therapy for ovarian cancer and a vaccine for breast cancer [2] Company Overview - Anixa is listed on NASDAQ under the ticker ANIX [2] - The company is engaged in the development of additional predevelopment candidates beyond its primary therapies [2] Leadership - Dr. Amit Kumar serves as the Chairman and CEO of Anixa Biosciences [1]

Core Insights - Anixa Biosciences has received a patent for its breast cancer vaccine technology, which targets the -lactalbumin protein, a promising approach for immunoprevention strategies against breast cancer [1][2][3] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a strong emphasis on developing next-generation preventive immunotherapies [2][5] - The company has a collaboration with Cleveland Clinic for the development of its breast cancer vaccine, which is part of a broader portfolio that includes ovarian cancer immunotherapy [5] Patent and Intellectual Property - The U.S. Patent Number 12,472,205 will be issued on November 18, 2025, extending the intellectual property protection for Anixa's breast cancer vaccine technology into the mid-2040s [1][2] - This patent reinforces the company's commitment to addressing breast cancer, which is projected to affect nearly 300,000 women in the U.S. by 2026 [1][3] Market Need - Breast cancer remains the most commonly diagnosed cancer among women globally, with over 297,000 new cases expected in the U.S. in 2025 and approximately 43,000 deaths anticipated [3] - There is currently no FDA-approved vaccine for breast cancer prevention, highlighting a significant unmet need in preventive oncology [3] Vaccine Mechanism - Anixa's investigational vaccine aims to stimulate the immune system to recognize and eliminate cells expressing -lactalbumin while sparing normal tissue, potentially minimizing off-target effects [4]

Core Insights - Anixa Biosciences has completed the final patient visit in its breast cancer vaccine clinical trial, marking a significant milestone in the first-in-human evaluation of the vaccine [1][3] - The vaccine aims to stimulate the immune system to recognize and target breast cancer before recurrence or development [2] - Preliminary results indicate that over 70% of participants demonstrated immune responses, suggesting the vaccine is well tolerated [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 in partnership with Cleveland Clinic, which has exclusive licensing rights to these technologies [5] - Anixa's business model involves partnering with leading research institutions to explore emerging technologies for cancer treatment [5] Clinical Trial Details - The Phase 1 trial included 35 women across three cohorts: 26 in the TNBC group, 4 in the Prevention group, and 5 in the Pembrolizumab group [2][6] - Comprehensive data analysis will follow the completion of patient visits, with results to be submitted to the Department of Defense and the FDA [3] - Full clinical results are scheduled to be presented at the San Antonio Breast Cancer Symposium on December 11, 2025 [3]

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]

Core Insights - Anixa Biosciences has received a Notice of Allowance for a new patent in Canada related to its breast cancer vaccine technology, enhancing its international intellectual property portfolio [1][2][3] - The patent provides composition-of-matter protection for Anixa's immunogenic approach to breast cancer prevention and treatment, which is exclusively licensed from Cleveland Clinic [1][4] - Breast cancer is the most commonly diagnosed cancer in women globally, accounting for approximately 25% of new cancer cases in women in Canada and 13% of female cancer deaths annually [3] Intellectual Property Expansion - The newly allowed Canadian patent complements existing and pending patents in the United States and other key global jurisdictions, reinforcing Anixa's leadership in cancer immunoprevention [2][5] - This expansion of the patent estate is crucial for future regulatory and commercial efforts outside the U.S., positioning the company for strategic global opportunities [2][3] Vaccine Technology - Anixa's breast cancer vaccine targets human α-lactalbumin, a protein aberrantly expressed in certain breast cancers, aiming to prime the immune system to prevent tumor formation while sparing normal tissue [4][5] - The company's broader vaccine platform also addresses other high-incidence cancers, transforming the approach to cancer prevention in the medical community [5] Company Overview - Anixa 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 [6] - The company partners with renowned research institutions to develop vaccines targeting various cancers, including breast and ovarian cancer, utilizing a unique business model that allows for continuous examination of emerging technologies [6]

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]