Anixa Biosciences Initiates Dosing in Fourth Cohort in its Ovarian Cancer CAR-T Clinical Trial
- Successful progression to fourth dosing cohort with no dose-limiting toxicities in third cohort
- Significant dose escalation achieved - 30x increase from initial dose
- Early signs of potential efficacy observed even at lower doses
- Novel targeting mechanism through FSHR specific to ovarian cells and tumor vasculature
- Still in early Phase 1 trial focused primarily on safety
- Limited patient population - only those who failed at least two prior therapies
- Efficacy data not yet conclusive at current stage
Insights
Anixa's ovarian cancer CAR-T trial advances to significantly higher dose with clean safety profile, showing encouraging clinical development progression.
This announcement marks a significant milestone in Anixa's Phase 1 CAR-T clinical trial for recurrent ovarian cancer. The advancement to the fourth dosage cohort delivering three million CAR-positive cells per kilogram - a
The clean safety profile observed thus far is crucial, as no dose-limiting toxicities were reported in the third cohort. This is especially important for CAR-T therapies, which can potentially cause serious adverse events like cytokine release syndrome and neurotoxicity. The ability to increase the dose by such a significant margin suggests a favorable safety profile to date.
Mechanistically, this CAR-T approach targets the follicle-stimulating hormone receptor (FSHR), which is reportedly expressed exclusively on ovarian cells, tumor vasculature, and certain cancer cells. This targeted approach potentially offers specificity that could enhance efficacy while reducing off-target effects.
The trial is enrolling a challenging patient population - women with recurrent ovarian cancer who have progressed after at least two prior therapies. This represents an area of significant unmet medical need where new therapeutic approaches are desperately needed.
While the CEO mentions "promising signs of potential efficacy" at lower doses, this should be interpreted cautiously as Phase 1 trials primarily assess safety rather than efficacy. Nevertheless, successful dose escalation keeps the development program on track and suggests this novel immunotherapeutic approach merits continued investigation for this difficult-to-treat malignancy.
Fourth cohort dose is three million CAR positive cells; thirty times higher than the first cohort dose
The fourth cohort in the trial will receive a dose of three million CAR-positive cells per kilogram of body weight, representing a thirtyfold increase from the first cohort. No dose-limiting toxicities were observed in the third cohort, enabling advancing to the fourth dosage cohort. This planned escalation marks a key step in assessing the safety and therapeutic effect of CAR-T cell therapy in patients with ovarian cancer.
Anixa's FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. The first-in-human trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor efficacy.
Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "With no dose-limiting safety issues observed in the third cohort, we have advanced to a higher dose level that is thirty times greater than the starting dose. Although the study is primarily focused on safety at these early, low-dose levels, we have seen promising signs of potential efficacy. "
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 an ovarian cancer immunotherapy program 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 Twitter, LinkedIn, 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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