Anixa Biosciences Wins Australian Patent Acceptance for Breast Cancer Vaccine, Expanding Global IP Estate
核心洞察
IP Australia (搜索) issued a Notice of Acceptance for Anixa Biosciences' breast cancer (搜索) vaccine patent, the first Australian patent covering the company's vaccine platform.
The patent, exclusively licensed from Cleveland Clinic, covers immunizing against human alpha-lactalbumin, a protein aberrantly expressed in certain breast cancers.
The acceptance complements existing patents in the United States, Europe, China, Japan and South Korea, where protection runs through 2040.
Anixa Biosciences has secured a Notice of Acceptance from IP Australia (搜索) for a patent covering its breast cancer (搜索) vaccine technology, marking the first Australian patent for the company's breast cancer vaccine platform and extending its intellectual property position into a market with increasing breast cancer incidence rates.
The patent, titled "Vaccine Adjuvants and Formulations," is exclusively licensed from Cleveland Clinic and lists co-inventors Dr. Justin Johnson and the late Dr. Vincent Tuohy. According to the company, the Notice of Acceptance confirms that the application has met the formal requirements for grant in Australia.
Patent Covers Alpha-Lactalbumin Immunization Strategy
The Australian patent covers Anixa's approach to immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer (搜索). The strategy focuses on so-called "retired" proteins, seeking to selectively activate the immune system to prevent tumor formation with minimal impact on normal tissue. Anixa is evaluating this approach particularly in aggressive breast cancers such as triple-negative breast cancer (搜索).
The acceptance complements existing patents issued in the United States, Europe, China and Japan. Separately, the Korean Ministry of Intellectual Property (MOIP) has issued Patent Number 10-2960889, a composition-of-matter patent providing protection for the breast cancer (搜索) vaccine approach in South Korea through 2040. That patent is also exclusively licensed from Cleveland Clinic.
"This newly accepted patent continues the broad international recognition of the novelty and potential of our breast cancer (搜索) vaccine," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "Each global patent we secure deepens the global foundation we are building for our breast cancer vaccine. As we continue clinical development in the US, our growing international patent estate further strengthens our ability to pursue global opportunities and potentially partner with larger pharmaceutical companies for worldwide commercialisation."
Phase 1 Data Support Continued Development
In a recently completed Phase 1 clinical trial conducted at Cleveland Clinic and funded by the U.S. Department of Defense, the vaccine met all major primary endpoints. The trial demonstrated that the vaccine was safe and well tolerated, generating protocol-defined immune responses in more than 74% of participants. The company states that these results support continued clinical development of the preventive and therapeutic breast cancer (搜索) vaccine.
The company notes that no preventive vaccine for breast cancer (搜索) is currently approved worldwide. Anixa describes its broader vaccine platform as aiming to address a range of high-incidence cancers, with additional cancer vaccines in development in collaboration with Cleveland Clinic. Cleveland Clinic is entitled to royalties and commercial revenues from these vaccine technologies, and in May 2024 Anixa expanded its partnership with the institution to develop additional cancer vaccines.
Ovarian Cancer CER-T Program Advances to Fifth Cohort
Anixa's therapeutic pipeline also includes liraltagene autoleucel (搜索) (lira-cel), an ovarian cancer (搜索) immunotherapy developed in partnership with Moffitt Cancer Center. The Phase 1 trial has advanced to its fifth cohort, with the first patient treated at the highest dose level evaluated to date — 1×10⁷ CAR-positive cells/kg following lymphodepletion.
The ongoing study (ClinicalTrials.gov NCT05316129) is evaluating a novel chimeric endocrine receptor-T cell (CER-T) therapy targeting the follicle-stimulating hormone receptor (搜索) (FSHR), which is expressed on ovarian cancer (搜索) cells but has limited expression in healthy tissues. The trial is designed to assess safety, tolerability and preliminary signs of efficacy across escalating dose levels in a highly pre-treated, recurrent ovarian cancer population that typically faces limited treatment options and poor prognosis.
To date, no dose-limiting toxicities have been observed across any cohort up to and including the prior dose level of 3×10⁶/kg CAR-T cells. As of July 6, 2026, five patients in the study have surpassed one year of survival following treatment, with individual patients surviving approximately 28, 20, 17, 17 and 13 months post-treatment, respectively.
Dr. Kumar noted that advancing to the fifth cohort without observing dose-limiting toxicities is a meaningful milestone, and that the survival signals are encouraging for this patient population.
Anixa Biosciences is a clinical-stage biotechnology company focused on the treatment and prevention of cancer, listed on the NASDAQ under the ticker symbol ANIX.