Company: ANIX
Filing Date: 2025-03-11
Form Type: 10-Q
Source: 0001493152-25-009854
Chunk: 3

Company: Anixa Biosciences Inc
Filing Date: 2025-03-11
Form: 10-Q
Item: Part I, Item 8
Chunk 3
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 had completed vaccinating all patients in 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 includes 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 have 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. These findings are promising, and as we continue the Phase 1 trial, 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. We
anticipate commencing the Phase 2 trial in 2025.

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