Anixa Biosciences Completes IND Transfer for Breast Cancer Vaccine
Anixa Biosciences announced that it has completed the transfer of the Investigational New Drug application, IND, for its breast cancer vaccine from Cleveland Clinic. Anixa is now the trial sponsor for future development of its breast cancer vaccine. The transfer of the IND is a natural and planned step in the progression of the vaccine's development. With enrollment completed and encouraging immune response and safety data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and has assumed full sponsorship of the IND. Anixa plans to utilize multiple clinical sites, including Cleveland Clinic, for the Phase 2 and other clinical trials.
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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.
