Anixa Biosciences Inc

Presentation Summary

****The trial is recruiting patients into three cohorts. Below is a description of each cohort as well as a summary of the key results and conclusions to date.

Cohort 1a participants: The patients enrolled are women who, within the previous three years, have completed standard of care (SOC) treatment, including surgery, for TNBC, the most lethal type of breast cancer. The study is evaluating the safety and tolerability of the vaccine, characterizing immune responses, and identifying a maximum tolerated dose (MTD).

Key Results: All three goals noted above have been achieved, in a group of 21 patients in this cohort. While the MTD has been successfully identified, additional dosages are being evaluated to confirm the MTD. In all patients at the current MTD, the vaccine was safe, producing no flu-like symptoms such as fever and myalgias, no abnormal clinical laboratory tests, or other observed adverse side effects. The only notable side effect was injection site irritation. The majority of patients exhibited protocol defined immune responses of α-lactalbumin specific T cell induced interferon gamma and interleukin-17.

Cohort 1b participants: The patients enrolled are women who carry mutations in their BRCA1, BRCA2, or PALB2 genes that place them at high risk of developing breast cancer, which is frequently TNBC. These women have chosen to have prophylactic mastectomies to reduce their risk of breast cancer. These participants were vaccinated prior to their surgeries, after which they were monitored for safety and immune responses. Immunohistochemistry (IHC) analysis will be performed on their resected breast tissue to evaluate their healthy breast tissue to determine if there are micro-foci of lactational cells, inflammation in the area of those foci and the presence of micro-tumors.

Key Results: Three women have been enrolled in this cohort to date. The safety and tolerability of the vaccine were similar to that in Cohort 1a. Enrollment of additional patients in this cohort is ongoing. The IHC analysis is ongoing and will be presented in a future scientific presentation.

**Cohort 1c participants:**The patients enrolled in this group are women diagnosed with TNBC who have completed SOC, including surgery, and are receiving pembrolizumab (Keytruda) in the adjuvant, post-surgery setting. Since Keytruda, a checkpoint inhibitor, is already a powerful immunotherapy with its own side effect profile, one of the primary goals of this cohort is to evaluate whether the administration of the vaccine in combination with Keytruda causes intolerable side effects. Immune responses are also being monitored in these participants.

**Key Results:**Three women have been enrolled in this cohort to date. Most notably, there were no major adverse side effects when the combination of vaccine and Keytruda were administered. As with the patients in cohorts 1a and 1b, the primary adverse side effect was injection site irritation. One patient exhibited a Grade 3 adverse event, which was a greater amount of irritation at one injection site. This patient had been diagnosed with breast cancer while she was pregnant, and she had recently lactated when the vaccine was administered. The trial protocol is being amended to provide for a six-month delay after lactation before a patient can be vaccinated. Similar to the patients enrolled in cohort 1a, the participants in this trial also exhibited antigen-specific T cell immune responses as hoped. Now that antigen-specific T cell responses have been confirmed in women receiving Keytruda and the vaccine, with no major side effects, the data provide the confidence to plan a Phase 2 study in the neoadjuvant setting with newly diagnosed breast cancer patients.

“Since the trial results to date have been very positive, the planned Phase 2 trial will enroll newly diagnosed breast cancer patients undergoing neoadjuvant treatment. Patients will be randomized in a one-to-one ratio, to receive either the standard of care, as defined by NCCN guidelines, alone or the vaccine plus standard of care. The important endpoints in this study will include characterization of T and B cell immune responses and repertoires, pathologic complete response and safety. Utilizing the vaccine in this type of setting will enable us to determine the effect within months for individual patients. The presence of a control group will allow us to determine efficacy in this setting. Assuming the trial data continues to be positive, such a trial may enable a quicker route to a strategic relationship with a large pharmaceutical partner for commercialization,” stated Dr. Kumar.

The poster presented at SITC can be viewed athttps://ir.anixa.com/events.

For more information and eligibility requirements visit clinicaltrials.gov.