Anixa Biosciences Announces Treatment of Second Patient in the Fifth Cohort of its Ovarian Cancer CAR-T Clinical Trial
Four patients have surpassed one year of survival after treatment, including one beyond two years.
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) has treated the second patient in the fifth cohort of its Phase 1 ovarian cancer CAR-T trial. The study at Moffitt Cancer Center evaluates an immune-cell therapy targeting the follicle stimulating hormone receptor in recurrent ovarian cancer. Cohort 5 receives 1×10⁷ CAR-positive cells/kg after lymphodepletion, a treatment to reduce immune cells, the highest dose evaluated in the study to date.
No dose-limiting toxicities have been observed across cohorts through the first patient treated in cohort 5. Four patients have survived approximately 28, 19, 17, and 17 months after treatment. The dose-escalating trial assesses safety, tolerability, and preliminary signs of efficacy.
Positive
- Minor pointSecond patient treated in cohort 5 advances the Phase 1 recurrent ovarian cancer trial.
- Minor pointNo dose-limiting toxicities observed across cohorts through the first patient treated in cohort 5.
- Minor pointFour patients have survived approximately 28, 19, 17, and 17 months after treatment.
Negative
- None.
Key Figures
- Cohort 5 dose
- 1×10⁷ CAR-positive cells/kg
- Highest dose level evaluated to date, following lymphodepletion
- Patients surviving over one year
- 4 patients
- Post-treatment in the Phase 1 study
- Longest reported survival
- Approximately 28 months
- Post-treatment
- Other reported survival durations
- 19, 17, and 17 months
- Post-treatment for three patients
Previous Clinical trial Reports
-
First cohort 5 advanced to the same dose; five patients had survived 13–28 months.
-
Ovarian CAR-T update reported multiple patients surviving more than one year.
-
Updated lira-cel observations reported extended survival and no dose-limiting toxicities in the first three cohorts.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
car-t medical
follicle stimulating hormone receptor medical
lymphodepletion medical
dose-limiting toxicities medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
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 receive 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 up to and including the first patient treated in the fifth 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 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 enrollment progresses."
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, 19, 17, and 17 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.
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
View original content to download multimedia:https://www.prnewswire.com/news-releases/anixa-biosciences-announces-treatment-of-second-patient-in-the-fifth-cohort-of-its-ovarian-cancer-car-t-clinical-trial-302895550.html
SOURCE Anixa Biosciences, Inc.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What dose is Anixa using in cohort 5 of its ovarian cancer CAR-T trial?
Cohort 5 receives 1×10⁷ CAR-positive cells per kilogram of body weight following lymphodepletion. This is the highest dose evaluated to date in the Phase 1 study, and the second patient in this cohort has been treated.
What survival and safety observations has Anixa reported in its ovarian cancer CAR-T trial?
Four patients have survived approximately 28, 19, 17, and 17 months after treatment, and no dose-limiting toxicities have been observed across cohorts through the first patient treated in cohort 5. The Phase 1 trial evaluates safety, tolerability, and preliminary signs of efficacy.