Anixa Biosciences Announces Presentation of Ovarian Cancer CAR-T Clinical Trial at ESMO Immuno-Oncology & Advanced Therapies Congress 2026

The fifth treatment cohort is complete, with no dose-limiting toxicities observed to date; further escalation awaits safety verification.

Rhea-AI Summary

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.

Positive

• Minor pointFifth cohort completed treatment at 1×10⁷ CAR-positive cells/kg following lymphodepletion, 100-fold above the first patient's dose.
• Minor pointNo dose-limiting toxicities have been observed in the study to date.
• Minor pointPreliminary stable disease was observed in the first patient 90 days following treatment.
• Minor pointFour patients survived more than one year after treatment, including one beyond two years, in preliminary observations.
• Minor point. Forward-looking: it has not happened yet and may not happen.Anixa anticipates a sixth cohort at 1×10⁸ CAR-positive cells/kg, 1,000-fold above the initial 1×10⁵ cells/kg dose.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.Routine safety verification is required before the anticipated advance to the sixth cohort.

Key Figures

Fifth-cohort dose: 1×10⁷ CAR-positive cells per kilogram Planned sixth-cohort dose: 1×10⁸ CAR-positive cells/kg Stable disease: 90 days +2 more

Fifth-cohort dose

1×10⁷ CAR-positive cells per kilogram

Following lymphodepletion

Planned sixth-cohort dose

1×10⁸ CAR-positive cells/kg

Following routine safety verification

Stable disease

90 days

First patient following treatment

Survival observation

4 patients

Survived more than one year after treatment

Survival observation

1 patient

Survived beyond two years after treatment

Key Terms

car-t, lymphodepletion, dose-limiting toxicities, autologous t-cells, +1 more

5 terms

car-t medical

"novel CAR-T therapy for recurrent ovarian cancer"

CAR-T is a type of cancer therapy that reprograms a patient’s own immune cells to seek and destroy specific cancer cells, like teaching guard dogs a new scent to track intruders. It matters to investors because CAR-T treatments can command high prices, drive strong revenue for successful developers, and carry regulatory and manufacturing risks that can sharply affect a company’s valuation and long-term growth prospects.

lymphodepletion medical

"following lymphodepletion, representing a 100-fold increase"

Lymphodepletion is a short medical treatment that lowers a patient’s lymphocytes, the immune cells that can interfere with certain cell-based therapies, to create a more supportive environment for the new therapy to work. Think of it like clearing a crowded garden bed before planting seeds: by temporarily reducing competing cells, the engineered therapy can take hold more effectively. Investors watch lymphodepletion because it affects clinical trial results, safety profiles, treatment adoption, and overall commercial potential.

dose-limiting toxicities medical

"no dose-limiting toxicities have been observed in the study"

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

autologous t-cells medical

"Phase 1 clinical trial of autologous T-cells genetically engineered"

T lymphocytes that are taken from a patient’s own body, manipulated or expanded outside the body, and then returned to that same patient as a therapy. Autologous T‑cell therapies use the patient’s own immune cells to target disease, which avoids immune rejection by a different donor but requires individualized collection, laboratory processing and re‑infusion for each patient.

follicle-stimulating hormone receptor medical

"to target the follicle-stimulating hormone receptor (FSHR)"

A protein on the surface of certain reproductive cells that binds follicle-stimulating hormone (FSH) and converts that signal into a cellular response, like a lock accepting a key or an antenna receiving a message. Drugs or tests that activate, block or measure this receptor can change fertility outcomes, hormone production or growth of some tumors, so it’s a common target for therapies and diagnostics that can create clinical progress and commercial value for investors.

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Dr. Robert Wenham, principal investigator of Anixa's Phase 1 clinical trial at Moffitt Cancer Center, to present on December 14 in London

SAN JOSE, Calif., Nov. 4, 2026 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that Robert Wenham, M.D., Chair of the Gynecologic Oncology Program at Moffitt Cancer Center ("Moffitt") and principal investigator of Anixa's ongoing Phase 1 clinical trial evaluating its novel CAR-T therapy for recurrent ovarian cancer, will present at the ESMO (European Society of Medical Oncology) Immuno-Oncology & Advanced Therapies Congress 2026, being held December 14–16, 2026, in London.

Dr. Wenham's presentation, titled "Phase 1 clinical trial of autologous T-cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer," will take place on Monday, December 14, 2026.

Anixa's Phase 1, dose-escalating clinical trial (ClinicalTrials.gov NCT05316129), conducted at Moffitt, is evaluating the safety, tolerability, and preliminary signs of efficacy of liraltagene autoleucel, or lira-cel, a novel CAR-T therapy targeting the follicle-stimulating hormone receptor (FSHR), which is expressed on ovarian cancer cells but has limited expression in healthy tissues.

The Company recently announced completion of treatment of the fifth cohort in the trial, in which patients received 1x10⁷ CAR-positive cells per kilogram of body weight following lymphodepletion, representing a 100-fold increase over the dose administered to the first patient in the study. Following routine safety verification, the Company anticipates advancing to a sixth cohort at a dose of 1x10⁸ CAR-positive cells/kg, representing a 1,000-fold increase over the initial dose of 1x10⁵ CAR-positive cells/kg.

To date, no dose-limiting toxicities have been observed in the study. The Company has also reported encouraging preliminary clinical observations, including the first patient exhibiting stable disease 90 days following treatment and four patients surviving more than one year after treatment, including one patient who has survived beyond two years.

"We are pleased that Dr. Wenham will be presenting our ovarian cancer CAR-T clinical program at this important international immuno-oncology conference," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "Our trial continues to advance through progressively higher dose levels as well as lymphodepletion, and we are encouraged by the safety profile and preliminary clinical observations reported to date. The completion of our fifth cohort represents another important step in evaluating this novel approach to treating recurrent ovarian cancer. We look forward to sharing our progress with the international oncology community as we continue working with our colleagues at Moffitt to advance this promising therapy."

The ESMO Immuno-Oncology & Advanced Therapies Congress brings together leading researchers, clinicians, and oncology experts from around the world to discuss advances in cancer immunotherapy and emerging therapeutic approaches. The international meeting focuses on the latest scientific and clinical developments in immuno-oncology, including cellular therapies, novel immune-targeting strategies, and the challenges of extending the benefits of immunotherapy to a broader range of cancers.

About Anixa Biosciences, Inc.
Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of liraltagene autoleucel, or lira-cel, an ovarian cancer immunotherapy being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on LinkedIn, X, Facebook and YouTube.

Forward-Looking Statements
Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

Contact:
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808

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SOURCE Anixa Biosciences, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When will Anixa present its ovarian cancer CAR-T trial at ESMO 2026?

Robert Wenham will present on December 14, 2026, in London. The principal investigator of Anixa's Phase 1 trial at Moffitt Cancer Center will discuss the study at the ESMO Immuno-Oncology & Advanced Therapies Congress.

What preliminary results has Anixa reported from its ovarian cancer CAR-T trial?

No dose-limiting toxicities have been observed to date. Preliminary clinical observations include stable disease in the first patient 90 days following treatment and four patients surviving more than one year after treatment, including one beyond two years.

What is Anixa's Phase 1 lira-cel trial evaluating?

The dose-escalating trial evaluates safety, tolerability and preliminary signs of efficacy in recurrent ovarian cancer. Lira-cel targets the follicle-stimulating hormone receptor, or FSHR, which is expressed on ovarian cancer cells but has limited expression in healthy tissues. The study is registered as NCT05316129.