Company: ANIX
Filing Date: 2025-09-10
Form Type: 10-Q
Source: 0001493152-25-013000
Chunk: 11

Company: Anixa Biosciences Inc
Filing Date: 2025-09-10
Form: 10-Q
Item: Part I, Item 1
Chunk 11
---
 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 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.

We
hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic
Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. The license
agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. Utilizing
this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against breast cancer,
focused initially on TNBC. The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during lactation
in a healthy woman’s mammary tissue.