Company: ANIX
Filing Date: 2025-09-10
Form Type: 10-Q
Source: 0001493152-25-013000
Chunk: 40

Company: Anixa Biosciences Inc
Filing Date: 2025-09-10
Form: 10-Q
Item: Part I, Item 8
Chunk 40
---
 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 U.S. Food and Drug Administration (“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. Between February and June 2024, we
treated the three patients 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 was also well-tolerated by the patients. 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.
From June 2025 through September 10, 2025, we treated three patients in the fourth dose cohort, administering a 30-times higher dose
of cells than the patients in the first dose cohort, and again the treatment appears to have been well-tolerated.

While
the dose levels in the first three cohorts were expected to be sub-therapeutic, multiple patients have exhibited anecdotal signs of efficacy,
including possible signs of T cell infiltration and tumor necrosis. While many patients have survived beyond expectations, one is still
alive two years past initial treatment and another survived over one year past 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.

    6

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