Anixa Biosciences Announces First Case of Stable Disease for Three Months in Ovarian Cancer CAR-T Clinical Trial

The disease-stabilization finding comes from one patient at the highest dose level evaluated to date.

Rhea-AI Summary

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.

Positive

• Minor pointFirst stable-disease response showed no cancer progression 90 days after treatment in one patient.
• Minor pointNo dose-limiting toxicities have been observed in any patients to date.
• Minor pointMultiple patients survived more than one year after treatment, including one beyond two years.
• Minor point. Forward-looking: it has not happened yet and may not happen.Further evaluation at current and future dose levels is planned by Anixa.

Negative

• Minor pointSurvival findings are early and anecdotal, as characterized by Anixa; Phase 1 primarily evaluates safety.

Key Figures

Stable disease duration: 90 days Dose level: 1×10⁷ CAR-positive cells per kilogram Post-treatment survival observations: Multiple patients over one year; one beyond two years

Stable disease duration

90 days

After treatment in the Phase 1 ovarian cancer CAR-T trial

Dose level

1×10⁷ CAR-positive cells per kilogram

Fifth dose cohort; highest dose level evaluated to date

Post-treatment survival observations

Multiple patients over one year; one beyond two years

Ovarian cancer CAR-T trial

Previous Clinical trial Reports

4 past events · Latest: Oct 01

Same Type 4 events

1. Oct 01

   cohort treatment update

   24h Move

   -5.1%

   Second patient treated in cohort five; no dose-limiting toxicities and survival observations reported.

2. Jul 06

   dose escalation

   24h Move

   -6.7%

   Trial advanced to its highest dose level; no dose-limiting toxicities and survival observations reported.

3. Jun 26

   CAR-T clinical update

   24h Move

   +6.5%

   Phase 1 CAR-T update reported multiple patients surviving over one year after treatment.

4. May 11

   survival update

   24h Move

   +1.0%

   Updated survival observations and preliminary safety findings reported no dose-limiting toxicities in three cohorts.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

dose-limiting toxicities, lymphodepletion, fshr, overall survival, +2 more

6 terms

dose-limiting toxicities medical

"no dose-limiting toxicities have been observed in any patients"

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.

lymphodepletion medical

"following lymphodepletion, representing the highest dose level evaluated"

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.

fshr medical

"targeting follicle stimulating hormone receptor (FSHR)"

FSHR is the protein on cell surfaces that binds follicle-stimulating hormone, a natural chemical that controls reproductive processes like egg and sperm development. Investors watch FSHR because drugs or diagnostics that target this receptor can affect fertility treatments, hormone-related disorders, and certain cancers; think of it as a lock that, when a new key is developed, can open markets for therapies or tests. Advances around FSHR can change a company’s product potential and regulatory risk.

overall survival medical

"early anecdotal findings of overall survival (OS)"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

radiological partial response medical

"eventually to radiological partial response (PR)"

An imaging-based designation meaning a tumor has shrunk by a predefined amount but has not disappeared. Under common oncology criteria (RECIST), a radiological partial response is typically at least a 30% decrease in the sum of diameters of target lesions compared with baseline, with no new lesions and no clear progression of non‑target disease; it is determined from radiology studies (CT, MRI, etc.) and therefore describes what scans show rather than complete eradication of disease or a clinical outcome.

complete response medical

"and hopefully complete response (CR)"

A complete response is a positive outcome in which a company’s efforts to address issues or questions fully resolve the problem, often meaning that no further action or investigation is needed. For investors, it signals that concerns have been thoroughly addressed, which can boost confidence in the company's stability or decision-making. Think of it like a doctor fully treating an illness, leaving no remaining symptoms.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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First patient in current dose cohort exhibited no progression of her cancer three months after
treatment

Multiple patients have survived more than one year, including one beyond two years

No dose-limiting toxicities observed to date

SAN JOSE, Calif., Oct. 5, 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 a patient in its ongoing Phase 1, dose-escalating, clinical trial evaluating its novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer, exhibited stable disease 90 days after treatment. This represents the first such response in Anixa's CAR-T cell therapy trial. Correlative studies evaluating presence and durability of CAR positive cells are ongoing.

The patient was treated in the fifth dose cohort and received a dose of 1×10⁷ CAR-positive cells per kilogram of body weight following lymphodepletion, representing the highest dose level evaluated to date in the study. To date, no dose-limiting toxicities have been observed in any patients.

The Phase 1 study is evaluating liraltagene autoleucel, or lira-cel, Anixa's 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 study is being conducted at Moffitt Cancer Center ("Moffitt").

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "While this Phase 1 study is primarily designed to evaluate safety, we are encouraged by our early anecdotal findings of overall survival (OS). In addition, an observation of stable disease for this duration, coupled with multiple patients having surpassed one year of survival following treatment, is very encouraging as we look forward to further evaluating lira-cel at current and future dose levels."

Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt and the principal investigator for the trial, added, "As we advance in this trial we hope to continue observing improved results in patients, from progressive disease to stable disease and eventually to radiological partial response (PR) and hopefully complete response (CR). This result, and the absence of dose-limiting toxicities observed thus far is encouraging as we continue to treat patients in the current and future dose cohorts."

About Lira-cel, Anixa's CAR-T Therapy for Recurrent Ovarian Cancer
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. Anixa's CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.

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.

What did Anixa's ovarian cancer CAR-T trial show at 90 days?

One patient exhibited stable disease 90 days after treatment, meaning her cancer had not progressed at that assessment. This was the first such response in the trial. She was the first patient in the fifth dose cohort and received 1×10⁷ CAR-positive cells per kilogram following lymphodepletion.

Has Anixa reported dose-limiting toxicities in its ovarian cancer CAR-T trial?

No dose-limiting toxicities have been observed in any patients to date. The ongoing Phase 1 study evaluates safety, tolerability and preliminary signs of efficacy across escalating dose levels.