Company: ANIX
Filing Date: 2025-09-10
Form Type: 10-Q
Source: 0001493152-25-013000
Chunk: 13

Company: Anixa Biosciences Inc
Filing Date: 2025-09-10
Form: 10-Q
Item: Part I, Item 1
Chunk 13
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 TNBC patients that have residual disease following treatment and are currently undergoing treatment with pembrolizumab
(Keytruda®). In November 2024, we presented the most recent data from each of the three arms of the trial at the Society for Immunotherapy
of Cancer (SITC) Annual Meeting. Key findings presented include i) patients exhibited antigen-specific immune responses at all dose levels
and in all three patient groups (Phase 1a, 1b and 1c), ii) patients receiving our vaccine in combination with Keytruda are not showing
any additional or more severe adverse side effects, and iii) no adverse side effects were seen other than varying degrees of injection
site irritation. We have completed enrollment and treatment in the trial, and have completed all patient follow up visits. We anticipate
reporting final Phase 1 data at the San Antonio Breast Cancer Symposium in December 2025. The Phase 1 findings to date are promising,
and we are preparing to initiate a Phase 2 clinical trial in the neo-adjuvant setting (pre-surgery) to determine possible therapeutic
effect of the vaccine. The Phase 2 trial will commence following final Phase 1 data release, FDA consultations, protocol development,
manufacturing and clinical site selection.

    7

We
hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating
to certain ovarian cancer vaccine technology. The license agreement requires us to make certain cash payments to Cleveland Clinic upon
achievement of specific development milestones. This technology pertains to among other things, the use of vaccines for the treatment
or prevention of ovarian cancers which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).
In healthy tissue, this protein regulates growth and development of egg-containing follicles in the ovary. While expression of AMHR2-ED
naturally and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with
ovarian cancer. Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.

In
May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the NCI’s PREVENT program. The
NCI is a part of the National Institutes of Health (“NIH”). The PREVENT program is a peer-reviewed agent development program
designed to support pre-clinical development of innovative