Announcement • Jul 14
Anixa Biosciences, Inc. Expands Global Patent Portfolio with Australian Patent Acceptance for Breast Cancer Vaccine Technology Anixa Biosciences, Inc. announced that IP Australia has issued a Notice of Acceptance for a new patent related to Anixa's breast cancer vaccine technology. This patent, exclusively licensed from Cleveland Clinic, will provide protection for the Company's novel approach to breast cancer treatment and prevention in Australia. The patent is titled, "Vaccine Adjuvants and Formulations," and the co-inventors are Dr. Justin Johnson and the late Dr. Vincent Tuohy, both of Cleveland Clinic. The acceptance further expands the international scope of Anixa's intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Australian patent complements patents issued in the United States and other key global jurisdictions, including Europe, China, and Japan, among others, and represents an important step toward potential future regulatory approvals and commercialization efforts outside the United States. In a recently completed Phase 1 trial, at Cleveland Clinic and funded by the U.S. Department of Defense, the vaccine met all major primary endpoints, was safe and well tolerated, and generated protocol defined immune responses in more than 74% of participants. These results support continued clinical development of the Company's novel preventive and therapeutic breast cancer vaccine. Breast cancer remains the most commonly diagnosed cancer among women worldwide, and while survival rates in Australia remain high, incidence rates have continued to increase. Despite significant advances in screening and treatment, there are currently no approved vaccines designed to prevent breast cancer. Anixa's breast cancer vaccine is based on immunizing against human a-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue, particularly in aggressive forms of the disease such as triple-negative breast cancer. By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company's broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention. If successful, the technology could represent one of the first preventive vaccine approaches targeting breast cancer. Live News • Jul 07
Anixa Biosciences Reaches Highest Dose Yet in Ovarian Cancer CAR-T Trial Anixa Biosciences and Moffitt Cancer Center have treated the first patient in the fifth cohort of a Phase 1 trial of Anixa’s FSHR-targeted CAR-T therapy for recurrent ovarian cancer, moving to the highest dose level tested so far.
Across all dose levels in the trial, no dose-limiting toxicities have been reported, and five patients have survived more than one year after treatment, which is meaningful for a heavily pre-treated population with limited options.
Anixa Biosciences’ stock trades at US$3.05, with the share price up 23.0% over the past 30 days, adding market focus to this early clinical update.
This trial update highlights early safety and durability signals for Anixa Biosciences while also underlining typical biotech risk, since longer-term efficacy, regulatory feedback and funding needs all remain open questions at this Phase 1 stage. Announcement • Jul 07
Anixa Biosciences Treats First Patient in Fifth Cohort of Phase 1 Clinical Trial for FSHR-Targeted CAR-T Therapy in Recurrent Ovarian Cancer Anixa Biosciences, Inc. has treated the first patient in the fifth cohort of its ongoing Phase 1, dose-escalating, clinical trial (ClinicalTrials.gov NCT05316129) evaluating its novel FSHR-targeted CAR-T/CER-T therapy for recurrent ovarian cancer. The Phase 1 study is evaluating a novel CAR-T therapy targeting follicle stimulating hormone receptor (FSHR), which 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. The patient received a dose of 1×107/kg CAR-positive cells following lymphodepletion, representing the highest dose level evaluated to date in the study. To date, no dose-limiting toxicities have been observed across any cohort up to and including the dose level of 3x106/kg CAR-T cells, the prior dose tested. As of the date of this release, 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. Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. 
