Anixa Biosciences Announces Execution of Data Transfer Agreement with Cleveland Clinic
IND Transfer Agreement: Anixa Biosciences has executed a data transfer agreement with Cleveland Clinic, marking a significant step in transferring the sponsorship of a breast cancer vaccine clinical trial to Anixa for further development.
Phase 2 Trial Plans: Following the completion of enrollment and positive immune response data from the Phase 1 trial, Anixa plans to advance the breast cancer vaccine into a Phase 2 clinical trial under its sponsorship.
Vaccine Target: The breast cancer vaccine targets α-lactalbumin, a protein associated with lactation that re-emerges in various breast cancer forms, aiming to establish an immune response against cancer cells expressing this protein.
Future Presentations: Anixa is looking forward to the presentation of final Phase 1 data by Cleveland Clinic at the San Antonio Breast Cancer Symposium on December 11, highlighting the progress made in the clinical trial.
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Anixa Biosciences Updates on Ovarian Cancer CAR-T Trial Outcomes
- Improved Patient Survival: In Anixa's ovarian cancer CAR-T clinical trial, of the 12 treated patients, 7 have exceeded the expected median survival of 3 to 4 months, indicating the potential effectiveness and hope of the treatment.
- Long-Term Survival Cases: One patient survived 28 months post-treatment, while three others have survived over a year (17, 15, and 14 months respectively), suggesting that this therapy may provide new survival opportunities for patients with recurrent ovarian cancer.
- Good Safety Profile: No dose-limiting toxicities (DLTs) have been observed to date, allowing Anixa's partner, Moffitt Cancer Center, to obtain IRB approval for significant dose escalation, further validating the safety and efficacy of the therapy.
- Dose Escalation Plan: Under the amended protocol, the CAR-T cell dosage will increase from 1×10⁵ to 1×10⁷ cells per kilogram to as high as 1×10⁹ cells, representing a two-order-of-magnitude increase that may enhance treatment efficacy, especially following lymphodepletion treatment.
Anixa Biosciences' CAR-T Therapy Receives Naming Approval
- Naming Approval: Anixa Biosciences' FSHR-targeted CAR-T therapy, “liraltagene autoleucel,” has received approval from the US Adopted Names Council, marking a significant step in the global commercialization process by ensuring a universally recognized and conflict-free drug name.
- Clinical Trial Progress: The therapy is currently undergoing a Phase 1 clinical trial in partnership with Moffitt Cancer Center, aimed at evaluating its safety and clinical activity in patients with recurrent ovarian cancer, which is expected to provide crucial data for future treatment options.
- Technological Innovation: Liraltagene autoleucel utilizes a novel CER-T technology that specifically targets the FSHR receptor, uniquely expressed in normal ovarian cells and tumor vasculature, potentially offering new hope for ovarian cancer treatment and enhancing Anixa's competitive edge in the biotechnology sector.
- Partnership Strength: Anixa's collaboration with the world-renowned Moffitt Cancer Center solidifies its position in cancer immunotherapy and expands its cancer treatment portfolio through partnerships with Cleveland Clinic for vaccine development, showcasing its unique business model and research capabilities.
Anixa Biosciences CAR-T Therapy Receives Naming Approval
- Naming Approval: Anixa's FSHR-targeted CAR-T therapy, 'liraltagene autoleucel', has received approval from the USAN Council, marking a significant step in the global commercialization process and enhancing its market recognition and legitimacy.
- International Recognition: The therapy's name has also been approved by the WHO's International Nonproprietary Names Expert Committee, ensuring consistency and conflict-free status in international markets, which bolsters Anixa's competitiveness in the global biotech sector.
- Clinical Trial Progress: Anixa is collaborating with Moffitt Cancer Center to conduct a Phase 1 clinical trial for 'liraltagene autoleucel', aimed at evaluating its safety and clinical activity in patients with recurrent ovarian cancer, which is expected to provide crucial data for future treatment options.
- Technological Innovation: This therapy utilizes a novel CER-T technology that targets tumor cells via the FSHR receptor, distinguishing it from traditional CAR-T therapies and showcasing Anixa's innovative capabilities and market potential in cancer immunotherapy.
Anixa Secures Mexican Patent for Breast Cancer Vaccine
- Patent Approval: Anixa Biosciences has received a patent allowance from the Mexican Institute of Industrial Property, marking an expansion of its international intellectual property coverage for breast cancer vaccine technology, thereby reinforcing its leadership in cancer immunotherapy.
- Market Opportunities: The patent complements existing patents in the U.S. and other key markets, laying the groundwork for Anixa's future regulatory and commercial efforts in regions with high breast cancer incidence like Mexico.
- Clinical Development Support: The vaccine is based on immunizing against human α-lactalbumin, aiming to selectively activate the immune system to prevent tumor formation, which is expected to improve breast cancer diagnosis and treatment outcomes for women in Mexico.
- Global Strategic Positioning: By strengthening its global patent estate, Anixa is paving the way for future international development and commercialization strategies, potentially partnering with larger pharmaceutical companies for worldwide commercialization.
Anixa Biosciences Declines Following Phase 1 Results for Breast Cancer Vaccine
Anixa Biosciences Phase 1 Trial Results: Anixa Biosciences (ANIX) reported a ~21% drop in stock after sharing phase 1 data for its breast cancer vaccine targeting α-lactalbumin, which showed that 74% of participants achieved immune responses.
Cohorts and Safety Findings: The trial involved 35 participants across three cohorts, with good safety and tolerability noted in the first two cohorts, while the third cohort experienced some Grade 3 adverse events related to injection-site irritation.
Future Trial Plans: Anixa indicated that the phase 2 trial design may include a combination study with Merck's Keytruda in the neoadjuvant setting for newly diagnosed breast cancer patients.
Market Reaction and Context: The market's reaction to the trial results has been cautious, with discussions around the justification of optimism regarding Anixa's upcoming phase 1 readout and other clinical programs.
Anixa Biosciences' Phase 1 Study Shows Breast Cancer Vaccine is Safe and Well Tolerated
Phase 1 Clinical Trial Results: Anixa Biosciences presented positive final results from its Phase 1 trial of a breast cancer vaccine at the 2025 SABCS, showing safety and immune response in 74% of participants.
Vaccine Development: The vaccine targets a-lactalbumin, a protein found in many breast cancers, and was developed in collaboration with the Cleveland Clinic and funded by the U.S. Department of Defense.
Future Studies: The company plans to advance to a Phase 2 neoadjuvant combination study with Keytruda in newly diagnosed breast cancer patients to further evaluate efficacy and long-term protection.
Stock Performance: Anixa's stock has fluctuated between $2.07 and $5.46 over the past year, closing at $4.80 before rising to $4.95 in overnight trading.
Anixa Biosciences Updates on Ovarian Cancer CAR-T Trial Outcomes
- Improved Patient Survival: In Anixa's ovarian cancer CAR-T clinical trial, of the 12 treated patients, 7 have exceeded the expected median survival of 3 to 4 months, indicating the potential effectiveness and hope of the treatment.
- Long-Term Survival Cases: One patient survived 28 months post-treatment, while three others have survived over a year (17, 15, and 14 months respectively), suggesting that this therapy may provide new survival opportunities for patients with recurrent ovarian cancer.
- Good Safety Profile: No dose-limiting toxicities (DLTs) have been observed to date, allowing Anixa's partner, Moffitt Cancer Center, to obtain IRB approval for significant dose escalation, further validating the safety and efficacy of the therapy.
- Dose Escalation Plan: Under the amended protocol, the CAR-T cell dosage will increase from 1×10⁵ to 1×10⁷ cells per kilogram to as high as 1×10⁹ cells, representing a two-order-of-magnitude increase that may enhance treatment efficacy, especially following lymphodepletion treatment.
Anixa Biosciences' CAR-T Therapy Receives Naming Approval
- Naming Approval: Anixa Biosciences' FSHR-targeted CAR-T therapy, “liraltagene autoleucel,” has received approval from the US Adopted Names Council, marking a significant step in the global commercialization process by ensuring a universally recognized and conflict-free drug name.
- Clinical Trial Progress: The therapy is currently undergoing a Phase 1 clinical trial in partnership with Moffitt Cancer Center, aimed at evaluating its safety and clinical activity in patients with recurrent ovarian cancer, which is expected to provide crucial data for future treatment options.
- Technological Innovation: Liraltagene autoleucel utilizes a novel CER-T technology that specifically targets the FSHR receptor, uniquely expressed in normal ovarian cells and tumor vasculature, potentially offering new hope for ovarian cancer treatment and enhancing Anixa's competitive edge in the biotechnology sector.
- Partnership Strength: Anixa's collaboration with the world-renowned Moffitt Cancer Center solidifies its position in cancer immunotherapy and expands its cancer treatment portfolio through partnerships with Cleveland Clinic for vaccine development, showcasing its unique business model and research capabilities.
Anixa Biosciences CAR-T Therapy Receives Naming Approval
- Naming Approval: Anixa's FSHR-targeted CAR-T therapy, 'liraltagene autoleucel', has received approval from the USAN Council, marking a significant step in the global commercialization process and enhancing its market recognition and legitimacy.
- International Recognition: The therapy's name has also been approved by the WHO's International Nonproprietary Names Expert Committee, ensuring consistency and conflict-free status in international markets, which bolsters Anixa's competitiveness in the global biotech sector.
- Clinical Trial Progress: Anixa is collaborating with Moffitt Cancer Center to conduct a Phase 1 clinical trial for 'liraltagene autoleucel', aimed at evaluating its safety and clinical activity in patients with recurrent ovarian cancer, which is expected to provide crucial data for future treatment options.
- Technological Innovation: This therapy utilizes a novel CER-T technology that targets tumor cells via the FSHR receptor, distinguishing it from traditional CAR-T therapies and showcasing Anixa's innovative capabilities and market potential in cancer immunotherapy.
Anixa Secures Mexican Patent for Breast Cancer Vaccine
- Patent Approval: Anixa Biosciences has received a patent allowance from the Mexican Institute of Industrial Property, marking an expansion of its international intellectual property coverage for breast cancer vaccine technology, thereby reinforcing its leadership in cancer immunotherapy.
- Market Opportunities: The patent complements existing patents in the U.S. and other key markets, laying the groundwork for Anixa's future regulatory and commercial efforts in regions with high breast cancer incidence like Mexico.
- Clinical Development Support: The vaccine is based on immunizing against human α-lactalbumin, aiming to selectively activate the immune system to prevent tumor formation, which is expected to improve breast cancer diagnosis and treatment outcomes for women in Mexico.
- Global Strategic Positioning: By strengthening its global patent estate, Anixa is paving the way for future international development and commercialization strategies, potentially partnering with larger pharmaceutical companies for worldwide commercialization.
Anixa Biosciences Declines Following Phase 1 Results for Breast Cancer Vaccine
Anixa Biosciences Phase 1 Trial Results: Anixa Biosciences (ANIX) reported a ~21% drop in stock after sharing phase 1 data for its breast cancer vaccine targeting α-lactalbumin, which showed that 74% of participants achieved immune responses.
Cohorts and Safety Findings: The trial involved 35 participants across three cohorts, with good safety and tolerability noted in the first two cohorts, while the third cohort experienced some Grade 3 adverse events related to injection-site irritation.
Future Trial Plans: Anixa indicated that the phase 2 trial design may include a combination study with Merck's Keytruda in the neoadjuvant setting for newly diagnosed breast cancer patients.
Market Reaction and Context: The market's reaction to the trial results has been cautious, with discussions around the justification of optimism regarding Anixa's upcoming phase 1 readout and other clinical programs.
Anixa Biosciences' Phase 1 Study Shows Breast Cancer Vaccine is Safe and Well Tolerated
Phase 1 Clinical Trial Results: Anixa Biosciences presented positive final results from its Phase 1 trial of a breast cancer vaccine at the 2025 SABCS, showing safety and immune response in 74% of participants.
Vaccine Development: The vaccine targets a-lactalbumin, a protein found in many breast cancers, and was developed in collaboration with the Cleveland Clinic and funded by the U.S. Department of Defense.
Future Studies: The company plans to advance to a Phase 2 neoadjuvant combination study with Keytruda in newly diagnosed breast cancer patients to further evaluate efficacy and long-term protection.
Stock Performance: Anixa's stock has fluctuated between $2.07 and $5.46 over the past year, closing at $4.80 before rising to $4.95 in overnight trading.
