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

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

Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: George T. Budd | N=30 ➔ 45 | Trial completion date: Sep 2023 ➔ Sep 2024 | Trial primary completion date: Jun 2023 ➔ May 2024

Enrollment change • 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

Phase I Trial of alpha-lactalbumin vaccine in high risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC (SABCS 2023) - "Dose level ≤ 2 appears to be the maximum tolerated dose. Based on immune response, additional intermediate dose levels may be studied. An additional cohort of patients receiving concurrent anti-PD1 treatment is being accrued."

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

Anixa Biosciences to Host Conference Call This Evening to Discuss Positive New Data from Ongoing Phase 1 Study of Breast Cancer Vaccine (PRNewswire) - "Anixa Biosciences, Inc...will publicly release new data this evening from the ongoing Phase 1 clinical trial of its breast cancer vaccine, which was presented for the first time today at the 2023 San Antonio Breast Cancer Symposium ("SABCS"). All interested parties are invited to join an upcoming conference call today at 6:30 pm ET to discuss the data."

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

Anixa Biosciences and Cleveland Clinic Present Positive New Data from Phase 1 Study of Breast Cancer Vaccine (PRNewswire) - P1 | N=30 | NCT04674306 | "Anixa Biosciences...announced new and updated positive results from the Phase 1 clinical trial of its breast cancer vaccine....The data were presented at the 2023 San Antonio Breast Cancer Symposium....Data from the 16 patients treated to date showed that: The majority of patients developed ELISpot (T-cell) responses that met the rigorous protocol-specified definition of an immune response, with a measurable but lesser magnitude of response noted in the remaining patients. 12 (75%) of the women had antigen-specific IFNγ and/or IL-17 ELISpot responses that were observed at all dose levels, while ELISA antibody responses were observed at Dose Level 2 and higher. A statistically significant (P = 0.03) increase in IFNγ over baseline (Day 0) was observed by Day 56; while a significant (P = 0.0001) increase in IL-17 over baseline was observed by Day 14."

P1 data • Triple Negative Breast Cancer

Anixa Biosciences Announces Opening of Enrollment for Keytruda Arm in Ongoing Breast Cancer Vaccine Clinical Trial (PRNewswire) - "Anixa Biosciences, Inc...today announced that its partner, Cleveland Clinic, has begun enrolling subjects in a treatment arm evaluating the combination of the Company's breast cancer vaccine with Keytruda® (pembrolizumab). An expansion of the ongoing Phase 1 dose escalation trial of Anixa's breast cancer vaccine, this treatment arm aims to determine if the vaccine/Keytruda combination increases immune response....'We are grateful to the U.S. Department of Defense for providing the funding for this new arm of the trial and look forward to Cleveland Clinic's presentation of the updated data from this trial at the San Antonio Breast Cancer Symposium (SABCS) in December'."

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

Researchers have begun Phase 2 of clinical trials for a vaccine that targets the most aggressive form of breast cancer (Audacy) - "'There's three common receptors that are expressed on a tumor: ER, PR, and HER 2,' explain Dr. William Dahut...'If you don't express any of those proteins, then you call them triple-negative, and then we don't have targeted therapies for the breast tumor.'"

Media quote

Phase I trial of alpha-lactalbumin vaccine in high-risk operable triple-negative breast cancer (AACR 2023) - "Dose level 2 appears to be the maximum tolerated dose. Accrual to dose levels 1 and 2 will be expanded to further define toxicity and immunologic effects. Accrual of patients with BRCA1 or PALB2 mutations planning to undergo prophylactic mastectomy is beginning in order to define the toxicity and immunologic effects in this group and to determine whether inflammatory changes from occult lactational foci will be produced."

P1 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • IFNG • IL17A • PALB2

Anixa Biosciences and Cleveland Clinic Present Positive Data for Phase 1 Study of Breast Cancer Vaccine (PRNewswire) - P1a | N=30 | NCT04674306 | "Anixa Biosciences...announced that Cleveland Clinic presented the most up-to-date data from the Phase 1 Trial of its breast cancer vaccine. The data presented showed that in the vaccinated women who have been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels....All participants in the Phase 1a study are women who have had triple negative breast cancer (TNBC) within the last three years and have been curatively treated having undergone standard of care. At the time of vaccination, these participants are tumor-free, as determined by standard diagnostic techniques, but are at high risk of recurrence."

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