alpha-lactalbumin vaccine / Anixa Biosci, Cleveland Clinic - LARVOL DELTA

Anixa Biosciences Receives Notice of Allowance from Chinese National Intellectual Property Administration for Patent Covering Breast Cancer Vaccine Technology (PRNewswire) - "Notice of Allowance marks first Chinese patent to be issued on Anixa Breast Cancer Vaccine. Expands global intellectual property coverage in markets with high breast cancer incidence. New patent will provide IP protection of Breast Cancer Vaccine in China into at least the 2040s."

Patent • Breast Cancer

Anixa Biosciences Announces Commencement of US FDA Approved IND Transfer to Support Upcoming Phase 2 Breast Cancer Vaccine Trial (Yahoo Finance) - "Anixa Biosciences, Inc...announced that, in collaboration with Cleveland Clinic, it has initiated the transfer of the Investigational New Drug (IND) application that supported the Phase 1 clinical trial of its breast cancer vaccine. With enrollment completed and encouraging immune response data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND."

IND • Breast Cancer • Triple Negative Breast Cancer

Anixa Biosciences Receives Notice of Allowance from Canadian Intellectual Property Office for Patent Covering Breast Cancer Vaccine Technology (PRNewswire) - "Anixa Biosciences...announced that the Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for a new patent related to its breast cancer vaccine technology. This patent, exclusively licensed from Cleveland Clinic, will provide composition-of-matter protection for the Company's novel immunogenic approach to breast cancer prevention and treatment in Canada. With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunoprevention. The Canadian patent complements issued and pending patents in the United States and other key global jurisdictions, and represents an important step toward future regulatory and commercial efforts outside the U.S."

Patent • Breast Cancer

Anixa Biosciences Awarded New U.S. Patent Extending Breast Cancer Vaccine IP Protection into 2040s (PRNewswire) - "Anixa Biosciences...announced that the United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,370,244 on July 29, 2025, covering key aspects of the Company's breast cancer vaccine technology. The patent protects novel methods of immunizing patients against breast cancer by administering an immunogenic composition containing human α-lactalbumin protein...making it an attractive target for immunoprevention strategies....The vaccine was invented at Cleveland Clinic, and this patent-along with others related to this technology-has been exclusively licensed to Anixa Biosciences. This issuance builds upon the Company's broad and expanding intellectual property portfolio, extending foundational patent protection for the breast cancer vaccine program into the mid-2040s."

Patent • Breast Cancer

Breast cancer vaccine shows promising results in phase 1 clinical trials (India Today) - P1 | N=35 | NCT04674306 | "A new breast cancer vaccine has completed phase 1 clinical trials, showing promising results....The trial involved 35 high-risk women, with over 75% developing a strong immune response. Phase 2 trials are set to begin in 2026, marking a significant step towards potentially preventing breast cancer."

New P2 trial • P1 data • Breast Cancer • Triple Negative Breast Cancer

Anixa Biosciences' Breast Cancer Vaccine Featured in NewsNation Interview (PRNewswire) - "Anixa Biosciences, Inc...today announced that its CEO, Dr. Amit Kumar, was interviewed on NewsNation's 'Elizabeth Vargas Reports' to discuss Anixa's breast cancer vaccine. The segment highlighted the potential of Anixa's vaccine to revolutionize the treatment and prevention of breast cancer."

Clinical • Breast Cancer

Anixa Biosciences Announces Completion of Enrollment in Phase 1 Trial of Breast Cancer Vaccine (GlobeNewswire) - "Anixa Biosciences, Inc...today announced the completion of enrollment in the Phase 1 clinical trial of its breast cancer vaccine. This novel vaccine, invented at Cleveland Clinic, is also being developed in partnership with Cleveland Clinic and the Phase 1 trial is fully funded by a grant from the U.S. Department of Defense (DoD)....The final patient visits are scheduled for August 2025. Once completed, the final study report will be submitted to the Department of Defense. A Clinical Study Report (CSR) will then be prepared for submission to the U.S. Food and Drug Administration. As part of the continued development process, the Investigational New Drug (IND) application will be transferred from Cleveland Clinic to Anixa....Anixa and Cleveland Clinic plan to submit for presentation all trial data at a major upcoming scientific meeting."

P1 data • Trial status • Triple Negative Breast Cancer

CASE6119: Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer (clinicaltrials.gov) - P1 | N=35 | Active, not recruiting | Sponsor: George T. Budd | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ Nov 2025

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • ER • HER-2 • PGR • PRL

Anixa Biosciences Receives Notice of Allowance from U.S. Patent and Trademark Office for Patent Covering Breast Cancer Vaccine Technology (PRNewswire) - "Anixa Biosciences...announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new patent related to the Company's innovative breast cancer vaccine technology. The patent along with others related to this technology, has been exclusively licensed to Anixa Biosciences, by Cleveland Clinic. The patent will expand the scope of immunogenic compositions utilized in Anixa's breast cancer vaccine. This newly allowed patent covers methods of immunizing patients against breast cancer by administering an immunogenic composition containing the human α-lactalbumin protein, a protein typically found in breast tissue during lactation but also expressed in certain breast cancers, making it an attractive target for immunoprevention strategies."

Patent • Breast Cancer

Anixa Biosciences' Breast Cancer Vaccine was Featured on Fox News' "America Reports" (PRNewswire) - "Anixa Biosciences, Inc...announced that its breast cancer vaccine was featured on Fox News' 'America Reports.' The segment highlighted the potential of Anixa's vaccine to revolutionize breast cancer prevention by targeting the disease at its earliest stages."

Clinical • Triple Negative Breast Cancer

Anixa Biosciences Chairman and CEO Discusses Pioneering CAR-T Cell Therapy and Breast Cancer Vaccine in Alpha Wolf Trading Interview (PRNewswire) - "In the discussion, Dr. Kumar provided insights into Anixa's groundbreaking CAR-T cell therapy for ovarian cancer and its breast cancer vaccine program, highlighting the Company's innovative approach to immunotherapy and cancer prevention. During the interview, Dr. Kumar provided key insights into Anixa's CAR-T cell therapy, which is designed to harness the power of the immune system to target ovarian cancer cells....Dr. Kumar also discussed Anixa's breast cancer vaccine program, which is designed to prevent triple-negative breast cancer (TNBC)—the most aggressive and hardest-to-treat form of breast cancer."

Clinical • Ovarian Cancer • Triple Negative Breast Cancer

Anixa Biosciences to Present at the 18th Annual European Life Sciences CEO Forum (PRNewswire) - "The conference brings together leading executives, investors, and industry experts from the global life sciences sector to discuss the latest innovations, investment trends, and partnership opportunities. Mr. Catelani will provide an update on Anixa's pipeline, highlighting its groundbreaking CAR-T therapy for ovarian cancer in collaboration with Moffitt Cancer Center, its breast cancer vaccine developed in partnership with Cleveland Clinic, and its expanding portfolio of cancer vaccine programs aimed at addressing multiple hard-to-treat cancers....The presentation will highlight recent clinical advancements and strategic initiatives aimed at accelerating the development of Anixa's innovative therapies. Additionally, Mr. Catelani will engage in one-on-one meetings with potential partners and investors."

Pipeline update • Ovarian Cancer • Triple Negative Breast Cancer

Anixa Biosciences' Chairman & CEO Dr. Amit Kumar Featured on CW39's H-Town Live to Discuss the Future of Breast Cancer Prevention (PRNewswire) - "Anixa Biosciences...announced that Dr. Amit Kumar, Chairman and CEO of Anixa, was featured on CW39's H-Town Live, where he discussed the Company's pioneering efforts in breast cancer prevention...During the segment, Dr. Kumar highlighted Anixa's groundbreaking research in developing a novel breast cancer vaccine in collaboration with the Cleveland Clinic. The vaccine, currently in clinical trials, aims to prevent triple-negative breast cancer (TNBC), the most aggressive and difficult-to-treat form of the disease."

Clinical • Triple Negative Breast Cancer

Anixa Biosciences CEO Provides Letter to Shareholders (PRNewswire) - "Anixa Biosciences, Inc...today provided the following letter to shareholders from the Company's, Chairman and CEO, Dr. Amit Kumar...Looking ahead, a Phase 2 study evaluating the vaccine in the neoadjuvant setting is planned to commence in 2025, marking an important next step in its development....2025 holds significant promise as we aim to build on the momentum of 2024: Breast Cancer Vaccine: Complete the Phase 1 trial, present additional clinical data at scientific conferences..."

New P2 trial • P1 data • Trial completion date • Breast Cancer • Triple Negative Breast Cancer

Phase I trial of alpha-lactalbumin vaccine in patients with high-risk early triple-negative breast cancer (TNBC) and those at genetic risk for TNBC (SITC 2024) - P1 | "Methods We are performing a Phase I trial of recombinant human aLA with GMP-grade zymosan adjuvant in Montanide ISA 51 VG vehicle in 3 cohorts of subjects: 1A) patients with high-risk TNBC who have completed all standard treatment; 1C) patients with TNBC who have residual cancer after primary chemo-immunotherapy and are receiving post-operative treatment with pembrolizumab +/- capecitabine; and 1B) patients with BRCA1, BRCA2, or PALB2 mutations who are undergoing risk-reducing mastectomies. Immune data in these new cohorts will be reported. Data from this trial will be insufficient to assess clinical efficacy and will be explored in Phase II.View this table:View inline View popup Download powerpoint Abstract 631 Table 1 CTCAE injection site reactions by dose level and grade"

Clinical • IO biomarker • P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • IFNG • IL17A • PALB2

CASE6119: Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: George T. Budd | Trial completion date: Mar 2025 ➔ Nov 2025 | Trial primary completion date: Nov 2024 ➔ May 2025

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • ER • HER-2 • PGR • PRL

Anixa Biosciences and Cleveland Clinic Present New Updated Positive Data from Phase 1 Study of Breast Cancer Vaccine at the 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting (PRNewswire) - P1 | N=45 | NCT04674306 | "The presentation, titled 'Phase I Trial of alpha-lactalbumin vaccine in high-risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC,' was presented by Dr. Emily Rhoades, FDA/IND Trial Program Manager at Cleveland Clinic....Data continues positive trend as additional patients are enrolled in 3 cohorts. Vaccine was safe and well tolerated by participants in all 3 cohorts. Protocol defined immune responses were exhibited in over 70% of patients. A Phase 2 study evaluating the vaccine in the neoadjuvant setting is planned to commence in 2025."

New P2 trial • P1 data • Triple Negative Breast Cancer

Anixa Biosciences Announces Timing of Public Release of Data from the Phase 1 Study of its Breast Cancer Vaccine at the 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting (PRNewswire) - "Anixa Biosciences, Inc...today announced that the presentation of additional data from the Phase 1 clinical trial of its breast cancer vaccine at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, will be made publicly available on the Company's website at 12:15pm CT on November 8, 2024. Concurrently, the Company will issue a press release providing an analysis of the data....As previously announced, the presentation, titled 'Phase I Trial of alpha-lactalbumin vaccine in high risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC,' will be presented at 12:15pm CT on November 8, 2024 at the SITC 39th Annual Meeting."

P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Anixa Biosciences and Cleveland Clinic to Present Additional Data from Phase 1 Study of Breast Cancer Vaccine at the 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting (PRNewswire) - "Anixa Biosciences...announced a presentation of additional data from the Phase 1 clinical trial of its breast cancer vaccine at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, being held virtually and in Houston, Texas, from November 6-10, 2024. The trial is being conducted in collaboration with Cleveland Clinic with funding by a grant from the U.S. Department of Defense. The presentation...will be presented by Dr. Emily Rhoades....at Cleveland Clinic."

P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Anixa Biosciences Unveils Phase 2 Study Plan for Breast Cancer Vaccine (PRNewswire) - "Anixa Biosciences, Inc...announced its strategic plan for a Phase 2 study for its breast cancer vaccine....The proposed Phase 2 trial will evaluate the efficacy of the vaccine administered in the neoadjuvant (before surgery) setting, in combination with chemotherapy and Keytruda (pembrolizumab)....The key objectives of the trial include evaluating the immunological response to the vaccine and comparing clinical efficacy of standard of care therapy alone with the vaccine plus standard of care therapy....The trial is expected to commence in 2025 and is projected to last approximately two to three years....Additional data from the Phase 1 trial will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in early November 2024."

Clinical protocol • New P2 trial • P1 data • Breast Cancer • Oncology • Solid Tumor

Anixa Biosciences Announces Japanese Patent on Breast Cancer Vaccine Technology (PRNewswire) - "Anixa Biosciences, Inc...announced that its collaborator, Cleveland Clinic, has received a 'Decision to Grant' notice from the Japan Patent Office (JPO) for the patent application titled 'Vaccine Adjuvants and Formulations'."

Patent • Breast Cancer • Oncology • Solid Tumor

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: George T. Budd | Trial completion date: Sep 2024 ➔ Mar 2025 | Trial primary completion date: May 2024 ➔ Nov 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • ER • HER-2 • PGR • PRL

Anixa Biosciences Expands Partnership with Cleveland Clinic to Develop Additional Cancer Vaccines (PRNewswire) - "Anixa Biosciences...announced that it has entered into a joint development agreement with Cleveland Clinic to develop novel vaccines for various cancer types. Cleveland Clinic is currently conducting a Phase 1 clinical trial targeting triple negative breast cancer (TNBC)...and an ovarian cancer vaccine is in pre-clinical development in collaboration with the National Cancer Institute. The vaccines focus on a novel scientific mechanism never used before in a cancer vaccine. By developing vaccines that immunize against 'retired' proteins found to be expressed in specific forms of cancer, the researchers are investigating if certain cancer cells can be destroyed as they arise, and ultimately prevent tumors from forming....Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company."

Licensing / partnership • Ovarian Cancer • Triple Negative Breast Cancer

Anixa Biosciences to Participate in the Sidoti Micro-Cap Virtual Conference on May 8 & 9, 2024 (PRNewswire) - "Anixa Biosciences, Inc....announced its participation in the Sidoti Micro-Cap Virtual Conference, taking place May 8-9, 2024....Dr. Kumar will discuss Anixa's preventative breast cancer vaccine, currently in Phase 1 clinical trials, that is showing strong positive data. Additional data releases expected in the coming months, and a Phase 2 trial is expected to commence in early 2025. Anixa's CAR-T cell therapy treatment for ovarian cancer is also in a Phase 1 trial and showing positive data."

New P2 trial • P1 data • Breast Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Anixa Biosciences Announces Presentation at 24th Annual World Vaccine Congress (PRNewswire) - "Anixa Biosciences, Inc...announced that Dr. Amit Kumar, Chairman and CEO of Anixa, will participate in the 24th Annual World Vaccine Congress being held April 1-4, 2024. Dr. Kumar will speak on Thursday, April 4th, in the Cancer Immunotherapy Track. Dr. Kumar will speak about positive interim results from the Phase 1 clinical trial of Anixa's breast cancer vaccine."

P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer