Company: ANIX
Filing Date: 2025-09-10
Form Type: 10-Q
Source: 0001493152-25-013000
Chunk: 41

Company: Anixa Biosciences Inc
Filing Date: 2025-09-10
Form: 10-Q
Item: Part I, Item 8
Chunk 41
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 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. This protein disappears when the woman is no longer lactating, but reappears in many forms
of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.

In
October 2021, following the FDA’s authorization to proceed, we commenced dosing patients in a Phase 1 clinical trial of our breast
cancer vaccine. This study, which has been fully funded by a U.S. Department of Defense grant to Cleveland Clinic, is a multiple-ascending
dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of the vaccine in patients with early-stage, triple-negative
breast cancer as well as monitor immune response. The study has been conducted at Cleveland Clinic. During the course of the Phase 1
study, participants received three vaccinations, each two weeks apart, and have been closely monitored for side effects and immune response.
The first segment of the study, Phase 1a, consisted of approximately 24 patients who had completed treatment for early-stage, triple-negative
breast cancer within the past three years and were currently tumor-free but at high risk for recurrence. Studies show that 42% of TNBC
patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years after standard
of care treatment. In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we had completed
vaccinating all patients in