News|Articles|September 11, 2025
Some Patients Treated in Anixa's Ovarian Cancer CER-T Trial Show Longer Than Expected Survival
Author(s)Noah Stansfield
The company specifically highlighted that one patient who was treated in the trial’s first cohort is still alive at 28 months.
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Anixa Biosciences stated that some patients treated in the phase 1 clinical trial (NCT05316129) evaluating its novel follicle stimulating hormone receptor (FSHR)-targeting chimeric antigen receptor (CAR)/chimeric endocrine receptor (CER) T-cell therapy for the treatment of ovarian cancer have shown survival times that exceed disease-specific median survival benchmarks.1
The company specifically highlighted that one patient who was treated in the trial’s first cohort is still alive at 28 months after being dosed. Although, Anixa clarified that these data are preliminary and from a small group of total patients.
Alongside this, the company noted that it has completed dosing in the fourth cohort of the trial, which is being carried out in collaboration with Moffitt Cancer Center. Patients in the fourth cohort were treated at a dose of 3×10⁶ CAR-positive cells per kilogram of body weight. This dose level constitutes around a 30-fold jump from the dose received by patients in the first cohort, which was 1×10⁵ cells/kg. As of yet, there have been no dose-limiting toxicities reported in the fourth cohort. Dosing in the fifth cohort, which will commence pending a safety review of the fourth cohort, will go forward with approximately 1×10⁷ cells/kg.
"With the completion of the fourth cohort, we are gaining important insights into the potential of our CAR-T therapy for ovarian cancer at higher dose levels,” Amit Kumar, PhD, the chairman and CEO of Anixa, said in a statement.1 “While this study is primarily designed to assess safety, we are encouraged by the early indications of potential efficacy, and look forward to initiating the next dose cohort following the standard safety review."
Notably, in September of last year, Anixa and Moffitt submitted a protocol amendment to the FDA for the phase 1 trial aimed at enabling the use of second doses for patients who may benefit.2 Anixa noted that it had previously obtained clearance of a single-patient investigational new drug (IND) application to redose a patient in the trial whose tumor showed cellular infiltration and necrosis in a biopsy, suggesting the CER-T therapy had produced biologic activity. In order to avoid the need to continuously submit single-patient IND applications on a case-by-case basis, the company’s protocol amendment will allow for patients in the trial to receive a second leukapheresis and dose of the CER-T, without the need for additional clearance.
"In initial phase 1 clinical trials, it is customary to begin with low, often subtherapeutic cell doses to verify safety, before increasing the dose levels,” principal investigator Robert Wenham, MD, MS, FACOG, FACS, the chair of the Gynecologic Oncology Department at Moffitt, said in a statement at the time.2 “In our study, the patient approved for a second dose by the individual IND received the starting, lowest dose. While initially meeting the criteria for progression due to size of her predominate tumor, her cancer has since remained relatively stable and she has not received additional therapy since her first infusion. We are hoping a second, higher dose may improve her overall response and outcome. In general, we anticipate that higher cell doses will lead to efficacy, but for solid tumors, a second dose may be needed in a subset of patients to improve the rate and durability of responses."
Later, in February 2025, Anixa announced that the protocol amendment had been approved by the FDA.3 In addition to allowing patients who may benefit to receive a second dose of the CER-T, the amendment also allows patients with sex cord-stromal tumors and Sertoli Leydig cell tumors to participate in the trial.
"We are excited about the approval of this protocol amendment, as it allows us to potentially enhance the efficacy of our CAR-T therapy by providing a second dose to patients who might benefit from it and to treat additional rare types of ovarian cancer,” Kumar said in a February 2025 statement.3 “This is a significant step in optimizing the treatment for ovarian cancer, and we look forward to continuing our work with Moffitt Cancer Center as we strive to improve outcomes for patients facing this difficult disease.”
REFERENCES
1. Anixa Biosciences and Moffitt Cancer Center Complete Dosing of Fourth Cohort in Ovarian Cancer CAR-T Clinical Trial; Multiple Patients Surpassing Median Expected Survival. News release. Anixa Biosciences, Inc. September 8, 2025. Accessed September 11, 2025. https://ir.anixa.com/press-releases/detail/1097/anixa-biosciences-and-moffitt-cancer-center-complete-dosing
2. Anixa Biosciences announces submission of protocol amendment for CAR-T trial. News release.Anixa Biosciences, Inc. September 30, 2024. Accessed September 11, 2025. https://ir.anixa.com/press-releases/detail/1052/anixa-biosciences-announces-submission-of-protocol
3. Anixa Biosciences Announces Approval of Protocol Amendment for Ovarian Cancer CAR-T Clinical Trial. News release. Anixa Biosciences, Inc. February 18, 2025. Accessed September 11, 2025. https://ir.anixa.com/press-releases/detail/1066/anixa-biosciences-announces-approval-of-protocol-amendment
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