Company: ANIX
Filing Date: 2025-09-10
Form Type: 10-Q
Source: 0001493152-25-013000
Chunk: 42

Company: Anixa Biosciences Inc
Filing Date: 2025-09-10
Form: 10-Q
Item: Part I, Item 8
Chunk 42
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 these expanded cohorts. In December 2023, we presented the immunological data collected to date at the San
Antonio Breast Cancer Symposium. The data presented show that in the vaccinated women who had been tested to date, various levels of
antigen-specific T cell responses were observed at all dose levels. Subsequently, we began vaccinating participants in additional dose
cohorts at varying dose levels of the different key components of the vaccine. Further, in November 2023, we commenced vaccination of
participants in the second segment of the trial, Phase 1b, that included participants who have never had cancer, but carry certain mutations
in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and had elected to have a prophylactic
mastectomy. Finally, in January 2024, we commenced vaccination of participants in the third segment of the trial, Phase 1c, that includes
post-operative 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