Company: ANIX
Filing Date: 2025-01-10
Form Type: S-8
Source: 0001493152-25-001798
Chunk: 10

Company: Anixa Biosciences Inc
Filing Date: 2025-01-10
Form: S-8
Chunk 10
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 in August 2022. Further, in May 2023 and August 2023, we treated the second and third patients in the trial, respectively, at the same dose level as the first patient, and the treatment was well-tolerated by the patients. In February 2024, May 2024 and June 2024, we treated the three patients, respectively, of the second dose cohort, where the patients were administered a three-times higher dose of cells than the patients in the first cohort. The treatment at this dose level has also been well-tolerated by the patients. While the dose levels in the first two cohorts were expected to be sub-therapeutic, two of the six patients exhibited some anecdotal signs of efficacy. Both have shown possible signs of tumor necrosis, and one is 20 months past initial treatment. In the case of this patient, due to the encouraging results with her initial treatment, we sought single patient Investigational New Drug (“IND”) application permission from the FDA to re-dose her. This re-dosing was approved by the FDA, and we administered her second treatment in October 2024. This second treatment appears to have been well-tolerated by the patient. In November 2024, we treated the first patient in the third dose cohort, where patients are administered a ten-times higher dose of cells than the patients in the first dose cohort. As of January 10, 2025, we have treated two patients in this dose cohort and the treatment at this dose level appears to be well-tolerated by the patients. We anticipate completing treatment of patients in the third dose cohort in February 2025, and commencing treatment of the fourth dose cohort—at a three-times higher dose than the third dose cohort—shortly thereafter.

This study is a dose-escalation trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T cells. The study is being conducted at Moffitt and will consist of up to 24 to 48 patients who have received at least two prior lines of chemotherapy. The study is estimated to be completed in two to three years depending on multiple factors including when the maximum tolerated dose is reached, the rate of patient enrollment, the significance of efficacy data and how long we maintain the two different delivery methods.

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