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Multiple Patients Surviving More Than One Year, Including one Beyond Two Years, with No Dose-Limiting Toxicities Observed to Date
Patients in Cohort 5 will receive 1×10⁷ CAR-positive cells/kg following lymphodepletion
Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that the first patient has been treated in the fifth cohort of its ongoing Phase 1, dose-escalating, clinical trial (ClinicalTrials.gov NCT05316129) evaluating its novel FSHR-targeted CAR-TCER-T therapy for recurrent ovarian cancer. The study is being conducted at Moffitt Cancer Center ("Moffitt").
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 patient received a dose of 1×10⁷/kg CAR-positive cells 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 up to and including the dose level of 3x106/kg CAR-T cells, the prior dose tested.
As of the date of this release, five patients in the study have surpassed one year of survival following treatment, with individual patients surviving approximately 28, 20, 17, 17, and 13 months post-treatment, respectively. 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.
Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "Advancing to the fifth cohort and highest dose level while observing no dose-limiting toxicities across the study to date is a meaningful milestone for the program. 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 five 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 weeks. These are precisely the kinds of signals we hoped to see at this stage. We look forward to further evaluating this novel solid tumor-specific CAR-T therapy as enrollment progresses."
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.
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.
