Anixa Biosciences CAR-T Therapy Receives USAN Approval
Anixa Biosciences announced that the U.S. Adopted Names, or USAN, Council approved "liraltagene autoleucel" for the non-proprietary name of the Company's novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. This U.S. approval follows the earlier approval for international use of the name by the International Nonproprietary Names, or INN, Expert Committee of the World Health Organization, WHO. The USAN and INN nomenclature schemes for CAR-T cell therapies follow a two-word structure describing the gene and cell component. A USAN is a non-proprietary name selected by the USAN Council to ensure safety, consistency and logic in the choice of names of U.S. medications.
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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 Vaccine Trial Achieves 74% Immune Response in Phase 1 Study
- Clinical Trial Success: Anixa Biosciences' α-lactalbumin vaccine met all major primary endpoints in its Phase 1 trial, with 74% of participants generating protocol-defined immune responses, demonstrating the vaccine's efficacy and safety, thus supporting its advancement into Phase 2 studies.
- Safety Assessment: Among 35 participants, the vaccine exhibited good tolerability at the maximum tolerated dose with no severe adverse effects reported, primarily noting injection site irritation, which lays a solid foundation for further clinical development.
- Collaborative Research: Conducted in partnership with Cleveland Clinic and funded by a grant from the U.S. Department of Defense, this trial highlights governmental support for cancer immunotherapy research while providing Anixa with essential funding for future growth.
- Market Potential: Given the challenges in treating triple-negative breast cancer, Anixa's vaccine technology has the potential to offer new solutions in this area, addressing the urgent market demand for innovative cancer treatments and enhancing the company's competitiveness in the biotechnology sector.
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 Vaccine Trial Achieves 74% Immune Response in Phase 1 Study
- Clinical Trial Success: Anixa Biosciences' α-lactalbumin vaccine met all major primary endpoints in its Phase 1 trial, with 74% of participants generating protocol-defined immune responses, demonstrating the vaccine's efficacy and safety, thus supporting its advancement into Phase 2 studies.
- Safety Assessment: Among 35 participants, the vaccine exhibited good tolerability at the maximum tolerated dose with no severe adverse effects reported, primarily noting injection site irritation, which lays a solid foundation for further clinical development.
- Collaborative Research: Conducted in partnership with Cleveland Clinic and funded by a grant from the U.S. Department of Defense, this trial highlights governmental support for cancer immunotherapy research while providing Anixa with essential funding for future growth.
- Market Potential: Given the challenges in treating triple-negative breast cancer, Anixa's vaccine technology has the potential to offer new solutions in this area, addressing the urgent market demand for innovative cancer treatments and enhancing the company's competitiveness in the biotechnology sector.
