Company: ANIX
Filing Date: 2025-05-28
Form Type: 10-Q
Source: 0001641172-25-012701
Chunk: 1

Company: Anixa Biosciences Inc
Filing Date: 2025-05-28
Form: 10-Q
Item: Part I, Item 8
Chunk 1
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collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), has begun human clinical
testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. After receiving
authorization from the FDA, we commenced enrollment of patients in a Phase 1 clinical trial and treated the first patient 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 still alive two years past initial treatment while the
other is still alive one year past initial treatment. In the case of the patient that is two years past initial treatment, 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. From November 2024 to February 2025, we treated three patients in the third dose cohort,
where they were administered a ten-times higher dose of cells than the patients in the first dose cohort. Consistent with the lower
dose cohorts, the treatment appears to have been well-tolerated by the patients. As of May 28, 2025, we are preparing to enroll
patients in the fourth dose cohort, where we will be administering a 30-times higher dose than the original dose cohort.

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