Anixa Biosciences Updates Ovarian Cancer CAR-T Trial Outcomes
Anixa Biosciences provided an update on patient outcomes observed in its ongoing Phase 1 ovarian cancer CAR-T clinical trial, following regulatory approval of a protocol amendment that enables substantial dose escalation. The ongoing Phase 1 trial is enrolling adult women with recurrent ovarian cancer, who have failed standard of care chemotherapy, and progressed after two or more prior therapies. To date, twelve patients have been treated in the trial at four dosage levels. Of these patients, seven have lived beyond their expected median survival of approximately three to four months, based on disease stage and prior therapy history. One patient survived 28 months following treatment, three patients have survived greater than one year following treatment and three patients have survived 11, 8 and 8 months, respectively. Three patients that have reached 15, 14 and 8 months remain alive, and one additional patient who was treated more recently, is also currently alive. Under the amended protocol, dosing may increase from the original range of 110 to 110 CAR-positive cells per kilogram of body weight to as high as 110 cells/kg, representing a two-order-of-magnitude increase. If no DLTs are observed at this level, additional escalation may be pursued at the discretion of the principal investigator. Anixa and Moffitt believe the favorable safety profile observed to date is partially attributable to the direct intra-peritoneal delivery of CAR-T cells, which differs from conventional intravenous administration and may reduce systemic toxicity while enhancing localized tumor targeting.
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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.
