Anixa Biosciences Makes Progress in the Clinical Evaluation of CER-T Approach to Treating Ovarian Cancer

Anixa Biosciences has dosed the fifth patient in its phase 1 clinical trial (NCT05316129) evaluating its novel follicle stimulating hormone receptor (FSHR)-targeting chimeric endocrine receptor (CER) T-cell therapy for the treatment of recurrent ovarian cancer.¹

Notably, the patient is the second to be treated in the trial’s second cohort, which is treating patients with a dose containing triple the number of CER T-cells (3x10⁵) used for the first 3 patients in the trial (1x10⁵), who were treated in the first cohort. Anixa stated that safety was confirmed in the first cohort.

The CER-T therapy is Anixa’s modified chimeric antigen receptor (CAR) T-cell therapy approach using an endocrine receptor (FSHR) as the target of the engineered T-cells. The clinical trial is being carried out in a collaboration between Anixa and Moffitt Cancer Center.

"With our fifth patient treated, our trial is progressing, and we continue to see that our therapy appears to be safe and well-tolerated," Amit Kumar, PhD, the chairman and chief executive officer ofAnixa Biosciences, said in a statement.¹ "The technology behind our novel CAR-T therapy differs from traditional CAR-T therapies by targeting the FSHR, which research indicates is exclusively expressed on ovarian cells in healthy adult females. We developed this approach to tackle preexisting difficulties with CAR-T cell therapies in solid ovarian tumors. In our trial, we will also explore several parameters for applying our CAR-T therapy to solid tumors in general."

The trial, which is taking place at Moffit in Tampa, Florida, is recruiting women aged 18 years and older who have progressing ovarian cancer for which at least 2 previous therapies were not successful in treating the disease. It is expected to enroll approximately 48 participants in total. The primary end point for the study is the maximum tolerated dose of the CER T-cells. Up to 5 dose levels in total may be assessed in the trial, with doses of 1x10⁶ CER T-cells, 3x10⁶ CER T-cells, and 1x10⁷ CER T-cells constituting the next 3 dose levels to be used after the aforementioned dose levels. The trial’s secondary end points include duration of response, duration of stable disease, and overall survival, all of which may be measured for up to 15 years. The trial began on April 28, 2022, and has an estimated primary completion date of March 2025 and an estimated study completion date of March 2029.

Anixa previously announced in October 2023 that dosing of the 3 patients in the first cohort was completed.² In September 2023, CGTLive® spoke with Pamela Garzone, PhD, the chief development officer of Anixa Biosciences, about the design of the trial. Garzone pointed out that the trial is evaluating intravenous administration of the experimental product against regional intraperitoneal administration and that the effect of use or nonuse of lymphodepletion prior to administration is also being explored.

“It has been shown preclinically that by giving these CAR T-cells regionally as opposed to by intravenous administration, that you have better homing to the tumor because there's direct cell-to-cell contact,” she said during the interview. To give it by intravenous administration, there's no homing to the tumor because you need an inciting inflammatory type of environment for those cells to go there, to do the T-cell priming, and to get activation. [With regional administration], you're actually putting the CAR-T right in the arena with the tumor...”

REFERENCES
1. Anixa Biosciences Commences Treatment of Fifth Patient in Ovarian Cancer CAR-T Clinical Trial. News release. Anixa Biosciences, Inc. May 21, 2024. Accessed May 28, 2024. https://ir.anixa.com/press-releases/detail/1042/anixa-biosciences-commences-treatment-of-fifth-patient-in
2. Anixa Biosciences Completes Treatment of First Patient Cohort in Ovarian Cancer CAR-T Clinical Trial. News release. Anixa Biosciences, Inc. October 13, 2023. Accessed October 16, 2023. https://ir.anixa.com/press-releases/detail/1025/anixa-biosciences-completes-treatment-of-first-patient