Company: ANIX
Filing Date: 2025-03-11
Form Type: 10-Q
Source: 0001493152-25-009854
Chunk: 2

Company: Anixa Biosciences Inc
Filing Date: 2025-03-11
Form: 10-Q
Item: Part I, Item 8
Chunk 2
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 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.

     5 

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
U.S. Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing patients in a Phase 1 clinical
trial of our breast cancer vaccine. This study, which is being 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 is being conducted at Cleveland Clinic. During
the course of the Phase 1 study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for
side effects and immune response. The first segment of the study, Phase 1a, will consist of approximately 24 patients who have completed
treatment for early-stage, triple-negative breast cancer within the past three years and are 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