Anixa Biosciences Announces Completion of Treatment of Fifth Cohort in its Ovarian Cancer CAR-T Clinical Trial
No dose-limiting toxicities have been observed, while the next dose escalation awaits a 30-day safety verification.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
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.
Positive
- Minor pointFifth-cohort dosing completed at 1×10⁷ CAR-positive cells/kg following lymphodepletion, the highest dose tested to date.
- Minor pointStable disease at 90 days observed in the first patient treated in the fifth cohort.
- Minor pointFour patients have survived approximately 28, 21, 17 and 17 months after treatment.
- Minor pointNo dose-limiting toxicities observed across any cohort to date.
- Minor point. Forward-looking: it has not happened yet and may not happen.Next-cohort dose planned at 1×10⁸ CAR-positive cells/kg following lymphodepletion.
Negative
- Minor point. Forward-looking: it has not happened yet and may not happen.Sixth-cohort start depends on a 30-day safety verification confirming no adverse effects in the fifth cohort.
Key Figures
- Fifth-cohort dose
- 1×10⁷ CAR-positive cells per kilogram
- Highest dose level evaluated to date
- Stable disease
- 90 days after treatment
- First patient treated in the fifth cohort
- Post-treatment survival
- 4 patients surpassed 1 year
- As of the release date
- Individual survival durations
- Approximately 28, 21, 17, and 17 months
- Post-treatment
- Dose-limiting toxicities
- None observed to date
- Across all cohorts
- Upcoming-cohort dose
- 1×10⁸ CAR-positive cells per kilogram
- Planned following the fifth-cohort safety verification
Previous Clinical trial Reports
-
Reported second cohort-five treatment at 1×10⁷ cells/kg and survival observations including 19 months.
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Key Terms
car-t medical
lymphodepletion medical
dose-limiting toxicities medical
follicle stimulating hormone receptor medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
First patient in fifth cohort exhibiting stable disease 90 days after treatment
Multiple patients surviving more than one year, including one beyond two years, with no dose-limiting toxicities observed to date
Patients in fifth cohort received 1×10⁷ CAR-positive cells/kg following lymphodepletion
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 patients in the fifth cohort 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 across any cohort.
Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "Ovarian cancer remains one of the deadliest cancers affecting women, and patients with recurrent disease face limited treatment options and poor outcomes. While this Phase 1 study is primarily designed to evaluate safety, we are highly encouraged that the most recently evaluated patient maintained stable disease 90 days after treatment and multiple patients have surpassed one year of survival following treatment, with one patient having survived beyond two years. Typically, these highly pre-treated patients survive a matter of weeks. We look forward to further evaluating this novel solid tumor-specific CAR-T therapy as we continue to increase dosage to 1×108 CAR-positive cells per kilogram of body weight following lymphodepletion in the upcoming cohort."
As of the date of this release, four patients in the study have surpassed one year of survival following treatment, with individual patients surviving approximately 28, 21, 17, and 17 months post-treatment, respectively. In addition, the first patient treated in the fifth dose cohort exhibited stable disease 90 days after treatment. The Company believes these outcomes are notable in a highly pre-treated, recurrent ovarian cancer population that has progressed after multiple prior lines of therapy and limited treatment options and poor prognosis.
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. The Phase 1 clinical trial is being conducted at Moffitt, under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt. 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
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What results has Anixa reported from its ovarian cancer CAR-T trial?
The first patient in the fifth cohort exhibited stable disease 90 days after treatment, and no dose-limiting toxicities have been observed across any cohort. Four patients in the study have survived approximately 28, 21, 17 and 17 months after treatment.
When will Anixa begin the sixth cohort of its ovarian cancer CAR-T trial?
Anixa expects the sixth cohort to begin following a 30-day safety verification confirming no adverse effects in the fifth cohort. The planned dose is 1×10⁸ CAR-positive cells per kilogram of body weight following lymphodepletion.