About Anixa Biosciences

Anixa Biosciences, Inc. operates as a biotechnology company. The company is developing vaccines and therapies that are focused on critical unmet needs in oncology. The company’s vaccine programs include the development of a preventative vaccine against triple negative breast cancer (TNBC), the most lethal form of breast cancer, as well other forms of breast cancer; and the development of a preventative vaccine against ovarian cancer. The company’s therapeutics programs include the development of a chimeric endocrine receptor T cell therapy, a novel form of chimeric antigen receptor T cell (CAR-T) technology, initially focused on treating ovarian cancer, which is being developed at its subsidiary, Certainty Therapeutics, Inc. (Certainty); and until March 2023, the development of anti-viral drug candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of the virus. The company holds an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (Cleveland Clinic) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. Utilizing this technology, the company is working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast cancer, focused initially on TNBC. The focus of this vaccine is a specific protein, a-lactalbumin, that is only expressed during lactation in a healthy mother’s mammary tissue. This protein disappears when the mother is no longer lactating, but reappears in many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice. In October 2021, following the U.S. Food and Drug Administration’s (FDA) authorization to proceed, the company commenced dosing patients in a Phase 1 clinical trial of its breast cancer vaccine. This study, which is being funded by a U.S. Department of Defense grant to Cleveland Clinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (MTD) of the vaccine in patients with early-stage, triple-negative breast cancer, as well as monitor immune response. The study is being conducted at Cleveland Clinic. In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, the company had completed vaccinating all patients in these expanded cohorts. In December 2023, the company presented the immunological data collected as of October 31, 2023 at the San Antonio Breast Cancer Symposium. The data presented show that in the vaccinated women who had been tested as of October 31, 2023, various levels of antigen-specific T cell responses were observed at all dose levels. The company has begun vaccinating participants in up to three additional dose cohorts at dose levels higher than the determined MTD and lower than the highest dose where it observed dose limiting toxicity. Further, the company has commenced vaccination of participants in the second segment of the trial, Phase 1b, that includes participants who have never had cancer, but carry certain genetic mutations, such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and have elected to have a prophylactic mastectomy. Finally, the company is enrolling participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease following neoadjuvant chemo-immunotherapy and are undergoing treatment with pembrolizumab (Keytruda). In November 2020, the company executed a license agreement with Cleveland Clinic pursuant to which the company was granted an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer vaccine technology. This technology pertains to among other things, the use of vaccines for the treatment or prevention of ovarian cancers, which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (AMHR2-ED). In healthy tissue, this protein regulates growth and development of egg-containing follicles in the ovary. While expression of AMHR2-ED naturally and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer. In May 2021, Cleveland Clinic was granted acceptance for its ovarian cancer vaccine technology into the National Cancer Institute’s (NCI) PREVENT program. The NCI is a part of the National Institutes of Health (NIH). The PREVENT program is a peer-reviewed agent development program designed to support pre-clinical development of interventions and biomarkers for cancer prevention and interception towards clinical trials. The scientific and financial resources of the PREVENT program are being used for the company’s ovarian cancer vaccine technology to perform virtually all pre-clinical research and development, manufacturing, and Investigational New Drug (IND) application enabling studies. The company’s subsidiary, Certainty, is developing immuno-therapy drugs against cancer. Certainty holds an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Wistar Institute (Wistar), the nation’s first independent biomedical research institute and a leading NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy technology. The company has initially focused on the development of a treatment for ovarian cancer, but it also may pursue applications of the technology for the development of treatments for additional solid tumors. The license agreement requires Certainty to make certain cash and equity payments to Wistar upon achievement of specific development milestones. Certainty, in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (Moffitt), has begun human clinical testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. After receiving authorization from the FDA, the company commenced enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022. Further, in May 2023 and August 2023, the company treated the second and third patients in the trial, respectively, at the same dose level as the first patient, and the treatment appears to have been well-tolerated by all patients treated to date. The company anticipates that it will begin enrolling the successive patient cohort, that it expects to give a three-times higher dose of cells, in the first calendar quarter of 2024. This study is a dose-escalation trial with two arms based on delivery method—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion, and efficacy of the modified T cells. The study is being conducted at Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of chemotherapy. The study is estimated to be completed in two to four years depending on multiple factors, including when maximum tolerated dose is reached, the rate of patient enrollment, and how long the company maintains the two different delivery methods. In April 2020, the company entered into a collaboration with OntoChem GmbH (OntoChem), which was later assigned to MolGenie GmbH, a company spun-out from OntoChem focused on drug discovery and development, to discover and ultimately develop anti-viral drug candidates against COVID-19. Through this collaboration, the company identified compounds that appeared to be effective in disrupting the main protease of SARS-CoV-2, the virus that causes the disease COVID-19. While the company’s compounds have shown promise as an effective treatment, results of animal studies indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may be developed. In March 2023, the company decided to pause further development of its COVID-19 therapeutic. The company continues to prosecute its U.S. patent applications of this technology and may decide to restart development at some time in the future. Breast and Ovarian Cancer Vaccines The company licensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of TNBC and other breast cancers, which express the a-lactalbumin protein. This protein is only expressed during lactation in healthy women, but may also be expressed in individuals with certain breast cancers, most notably TNBC, the most lethal form of breast cancer. Further, the company has licensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of ovarian cancers, which express AMHR2-ED. This protein regulates growth and development of egg-containing follicles in the ovary and its expression naturally and markedly declines after menopause. However, AMHR2-ED is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer. The breast cancer vaccine technology licensed from Cleveland Clinic has identified a protein, alpha-lactalbumin, that is present in healthy breast tissue only when a woman is lactating and disappears when she stops nursing her child. Alpha-lactalbumin is never present on any other cell in the body. However, it does show up in many types of breast cancer, including TNBC, an aggressive and deadly form of the disease. By developing a vaccine that targets alpha-lactalbumin, the company feels the immune system can destroy these breast cancer cells as they arise and ultimately prevent breast tumors from forming. The ovarian cancer vaccine technology licensed from Cleveland Clinic has identified the AMHR2-ED protein, the expression of which is involved in egg production in the ovaries and is no longer expressed after menopause. AMHR2-ED is not meaningfully present on any other cell in the body. By developing a vaccine that targets AMHR2-ED, the company feels the immune system can destroy these ovarian cancer cells as they arise and ultimately prevent tumors from forming. In October 2021, Cleveland Clinic began treating patients in a Phase 1 clinical trial of the company’s breast cancer vaccine. In addition, the company and its partners at Cleveland Clinic continue working with the NCI who are or will be performing pre-clinical research and development, manufacturing, and IND-enabling studies to advance its ovarian cancer vaccine technology toward human clinical testing. CAR-T Therapeutics Certainty was formed to develop immuno-therapy drugs against cancer. In November 2017, the company entered into a license with Wistar whereby it obtained rights to certain intellectual property surrounding Wistar’s chimeric endocrine receptor targeted therapy technology. The company’s CAR-T technology is initially focused on ovarian cancer and is based on engineering killer T cells with the Follicle Stimulating Hormone (FSH) to target ovarian cells that express the FSH-Receptor. The company has been working with researchers at H. Lee Moffitt Cancer Center and Research Institute, Inc. (Moffitt) to develop its CAR-T therapy. Moffitt is one of the top cancer centers in the country with pre-clinical and clinical expertise with CAR-T technology. Moffitt has conducted many of the highest profile CAR-T trials in the world. Research and Development The company’s research and development expenses were approximately $4,769,000 in the year ended October 31, 2023. History The company was founded in 1982. It was incorporated in 1982 under the laws of the state of Delaware. The company was formerly known as CopyTele, Inc. and changed its name to ITUS Corporation in 2014. Further, the company changed its name to Anixa Biosciences, Inc. in 2018.