Anixa Biosciences, Inc. reports biotechnology developments tied to the treatment and prevention of cancer. The company's recurring news centers on its investigational breast cancer vaccine, developed with Cleveland Clinic and based on an α-lactalbumin immune-targeting approach, and liraltagene autoleucel, or lira-cel, an FSHR-targeted CAR-T therapy for recurrent ovarian cancer.
Company updates also cover clinical-trial observations, scientific conference presentations, intellectual-property protection for vaccine technology, manufacturing arrangements for clinical materials, and management presentations describing Anixa's oncology pipeline and business model.
Anixa Biosciences (NASDAQ: ANIX) announced a presentation on its ovarian cancer CAR-T trial at ESMO in London on December 14, 2026. Principal investigator Robert Wenham of Moffitt Cancer Center will present the ongoing Phase 1 study of lira-cel, a therapy using genetically engineered T-cells.
The fifth cohort completed treatment at 1×10⁷ CAR-positive cells/kg following lymphodepletion, 100 times the first patient's dose. Anixa anticipates a sixth cohort at 1×10⁸ cells/kg following routine safety verification. No dose-limiting toxicities have been observed to date. Preliminary observations include stable disease in the first patient 90 days after treatment and four patients surviving more than one year after treatment, including one beyond two years.
Anixa Biosciences (NASDAQ: ANIX) completed dosing of the fifth cohort in its Phase 1 CAR-T trial for recurrent ovarian cancer. Patients received 1×10⁷ CAR-positive cells per kilogram following lymphodepletion, a treatment that reduces immune cells, at the highest dose tested so far. The therapy targets follicle stimulating hormone receptor (FSHR).
The first patient in the fifth cohort exhibited stable disease 90 days after treatment. Four patients across the study have survived approximately 28, 21, 17 and 17 months after treatment. No dose-limiting toxicities have been observed across any cohort. Anixa expects the sixth cohort to begin after a routine 30-day safety verification confirms no adverse effects in the fifth cohort, with a planned dose of 1×10⁸ CAR-positive cells per kilogram following lymphodepletion. The study at Moffitt Cancer Center assesses safety, tolerability and preliminary efficacy.
Anixa Biosciences (ANIX) announced that ovarian cancer CAR-T therapy inventor Jose Conejo-Garcia will deliver a conference keynote on November 3, 2026. The Ovarian Cancer Midwest Focus Conference, hosted by Mayo Clinic and University of Minnesota, runs November 2–3 in Rochester, Minnesota.
Anixa's lira-cel, a therapy using modified immune cells, is being evaluated in an ongoing Phase 1 trial with Moffitt Cancer Center. No dose-limiting toxicities have been observed to date. Four patients have surpassed one year of survival following treatment, including one beyond two years. The first patient treated at the highest dose to date exhibited stable disease 90 days after treatment.
Anixa Biosciences (NASDAQ: ANIX) reported its first case of stable disease lasting 90 days in its ovarian cancer CAR-T trial. The patient had no cancer progression at that assessment in the ongoing Phase 1 dose-escalation study of liraltagene autoleucel, or lira-cel, at Moffitt Cancer Center. CAR-T therapy uses modified immune cells; lira-cel targets the follicle stimulating hormone receptor.
The first patient in the fifth dose cohort received 1×10⁷ CAR-positive cells per kilogram following lymphodepletion, the highest dose evaluated to date. No dose-limiting toxicities have been observed in any patients. Multiple patients have survived more than one year after treatment, including one beyond two years. Anixa described the survival findings as early and anecdotal. The study primarily evaluates safety, alongside tolerability and preliminary efficacy; studies of CAR-positive cell presence and durability remain ongoing.
Anixa Biosciences (NASDAQ: ANIX) has treated the second patient in the fifth cohort of its Phase 1 ovarian cancer CAR-T trial. The study at Moffitt Cancer Center evaluates an immune-cell therapy targeting the follicle stimulating hormone receptor in recurrent ovarian cancer. Cohort 5 receives 1×10⁷ CAR-positive cells/kg after lymphodepletion, a treatment to reduce immune cells, the highest dose evaluated in the study to date.
No dose-limiting toxicities have been observed across cohorts through the first patient treated in cohort 5. Four patients have survived approximately 28, 19, 17, and 17 months after treatment. The dose-escalating trial assesses safety, tolerability, and preliminary signs of efficacy.
Anixa Biosciences (ANIX) received its first Australian composition-of-matter patent for its breast cancer vaccine technology, providing exclusive protection in Australia through 2040. The patent, issued by IP Australia as Patent Number 2020221280 and titled “Vaccine Adjuvants and Formulations,” covers a vaccine approach exclusively licensed from Cleveland Clinic.
The Australian patent complements Anixa’s existing portfolio in the United States and other markets including Europe, China and Japan, broadening its global intellectual property estate. A completed Phase 1 trial at Cleveland Clinic, funded by the U.S. Department of Defense, met all major primary endpoints, showed the vaccine was safe and well tolerated, and produced protocol-defined immune responses in more than 74% of participants, supporting further clinical development.
Anixa Biosciences (ANIX) appointed Carmen Guerra, M.D., M.S.C.E., F.A.C.P., of the University of Pennsylvania, to its Cancer Business Advisory Board.
The company said it expects Dr. Guerra’s expertise to support advancement of its breast cancer vaccine toward a planned Phase 2 trial and its ongoing Phase 1 ovarian cancer CAR-T therapy trial. Dr. Guerra is a Professor of Medicine and of Biostatistics and Epidemiology at the Perelman School of Medicine and Associate Director of Community Outreach and Engagement at the Abramson Cancer Center.
Her research focuses on increasing participation in cancer screening and clinical trials, and she leads several Penn Medicine cancer screening programs. She also plays key roles in NCI-funded HPV prevention research and in developing American Cancer Society clinical practice guidelines.
Anixa Biosciences (ANIX) will feature its Chairman and CEO, Dr. Amit Kumar, and breast cancer vaccine clinical trial patient, Sherie Steinberg, in an interview on the RedChip Small Stocks, Big Money™ show airing on Bloomberg TV on Saturday, September 12, at 7:00 PM ET.
Dr. Kumar will discuss recently announced successes in cancer vaccine development and Anixa’s breast cancer vaccine, which the company expects could be used to treat cancer, prevent recurrence, and potentially reduce the risk of developing breast cancer. Steinberg, a breast cancer survivor who participated in Anixa’s Phase 1 clinical trial, will share her cancer journey and experience receiving the vaccine. Bloomberg TV reaches an estimated 73 million U.S. homes, and the segment will also be available online at a specified YouTube link.
Anixa Biosciences (ANIX) will present at the Nasdaq & LD Micro Inaugural SF Summit on September 9, 2026, at Nasdaq’s San Francisco headquarters.
Chairman and CEO Dr. Amit Kumar will speak at 3:40 PM PT, followed by a breakout session. The presentation will cover updates on Anixa’s two clinical programs: a CAR-T therapy for recurrent and resistant ovarian cancer in an ongoing Phase 1 trial with Moffitt Cancer Center, and a therapeutic and prophylactic breast cancer vaccine whose Phase 1 trial at Cleveland Clinic, funded by the U.S. Department of Defense, met all primary endpoints. Dr. Kumar will also outline future plans for a Phase 2 vaccine trial and place the program in context with recent positive melanoma vaccine data.
Anixa Biosciences (NASDAQ: ANIX) will present at the 2026 Cantor Fitzgerald Global Healthcare Conference in New York on September 11, 2026, at 8:00 AM ET. President, COO & CFO Mike Catelani will review its breast cancer vaccine, which completed a Phase 1 trial funded by the U.S. Department of Defense, meeting all primary endpoints, including safety, and generating protocol-defined immune responses in 74% of participants. Preparations are underway for Phase 2. He will also discuss the ovarian cancer CAR-T therapy lira-cel, now at the fifth and highest dose cohort with lymphodepletion, where no dose-limiting toxicities have been observed and four patients have surpassed one year of survival, the longest at about 28 months.