Anixa Biosciences, Inc. has secured a Notice of Acceptance from IP Australia for a patent related to its breast cancer vaccine technology, expanding its global intellectual property portfolio. The patent, exclusively licensed from Cleveland Clinic, is titled "Vaccine Adjuvants and Formulations" and lists co-inventors Dr. Justin Johnson and the late Dr. Vincent Tuohy. This acceptance marks the first Australian patent covering Anixa's breast cancer vaccine platform, reinforcing the company's strategy to protect its technology in markets with increasing breast cancer incidence rates.

Patent Details

The issuance of the Notice of Acceptance confirms that the patent application has met formal requirements for grant in Australia. This development complements existing patents issued in the United States, Europe, China, and Japan, strengthening Anixa's position in cancer immunotherapy. The patent covers the company's novel approach to immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer.

Clinical Development

In a recently completed Phase 1 trial 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. These results support continued clinical development of the preventive and therapeutic breast cancer vaccine.

Strategic Impact

"This newly accepted patent continues the broad international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. The growing international patent estate aims to strengthen the company's ability to pursue global opportunities and potentially partner with larger pharmaceutical companies for worldwide commercialization.

Company Overview

Anixa Biosciences is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. The company is listed on the NASDAQ under the ticker symbol ANIX. Its vaccine portfolio includes technologies developed in collaboration with Cleveland Clinic, targeting "retired" proteins expressed in certain forms of cancer.

Anixa Biosciences, Inc. and Moffitt Cancer Center have advanced the Phase 1 clinical trial for liraltagene autoleucel (lira-cel) to its fifth cohort, treating the first patient with the highest dose level evaluated to date. The patient received 1×10⁷ CAR-positive cells/kg following lymphodepletion. This milestone is significant for 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 3x10⁶/kg CAR-T cells.

The ongoing Phase 1 study (ClinicalTrials.gov NCT05316129) is evaluating a novel chimeric endocrine receptor-T cell (CER-T) therapy targeting the follicle-stimulating hormone receptor (FSHR). FSHR is expressed on ovarian cancer 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.

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. Amit Kumar, Chairman and CEO of Anixa Biosciences, noted that advancing to the fifth cohort without observing dose-limiting toxicities is a meaningful milestone, and the survival signals are encouraging for this patient population.

Anixa's therapeutic portfolio includes the ovarian cancer immunotherapy developed in collaboration with Moffitt Cancer Center and vaccines licensed from Cleveland Clinic. The breast cancer vaccine technology is protected by Patent Number 10-2960889 issued by the Korean Ministry of Intellectual Property (MOIP), which secures the company's approach in South Korea through 2040. The breast cancer vaccine previously met all major primary endpoints in a Phase 1 clinical trial, with protocol-defined immune responses generated in 74% of participants.

Key Clinical Trial Details