On January 26, 2021 BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported the presentation of results from clinical studies with its lead product candidate, Bria-IMT, summarized in a poster session held January 25-27 during the 2021 Keystone Symposium, "Emerging Cell Therapies: Realizing the Vision of NextGen Cell Therapeutics," a virtual scientific conference (Press release, BriaCell Therapeutics, JAN 26, 2021, View Source [SID1234574784]).
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Overall, the data suggests a potentially significant survival benefit for the patients treated with the Bria-IMT regimen alone or in combination with checkpoint inhibitors, especially in those with moderately or well differentiated tumors or those who match Bria-IMT at 2 HLA alleles. We hypothesize that Bria-IMT, with a molecular signature most closely related to moderately or well differentiated tumors, may result in disease control especially in patients with moderately-well differentiated tumors. The patient data summarized and discussed belong to previously-disclosed patients (i.e., no incremental numbers enrolled).
Dr. Bill Williams, BriaCell’s President & CEO, presented the clinical and pathological data of Bria-IMT monotherapy (i.e., the Bria-IMT regimen alone) and Bria-IMT in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA; manufactured by Merck & Co., Inc.), and more recently, Incyte’s INCMGA00012 (under a corporate collaboration with Incyte Corporation), in advanced breast cancer.
Details and results on the poster presentation are summarized below:
Poster Title: Personalized off-the-shelf whole cell immunotherapy for cancer
Monotherapy Study – 27 patients: The patients were heavily pre-treated (median of 5 prior therapy regimens). Disease control including stable disease (SD), partial responses (PR) or complete responses (CR) was seen in 8 patients (30%) suggesting clinical benefit. Importantly, disease control was more frequent in patients who had 2 or more HLA matches with Bria-IMT (67%) or had moderately or well differentiated tumors (63%) suggesting the potential importance of these factors in designing the next generation of personalized immunotherapies.
Combination Study – 12 patients (Bria-IMT regimen with checkpoint inhibitors): The patients were heavily pre-treated (median of 6 prior therapy regimens). Disease control was seen in 4 patients (33%). Importantly, patients with moderately or well differentiated tumors were more likely to achieve disease control (3/4, 75%) suggesting clinical benefit in this subset of patients. Furthermore, the data suggests the potential additive or synergistic effects of check point inhibitors when combined with the Bria-IMT regimen.
Patients with moderately or well differentiated tumors: The patients with moderately or well differentiated tumors (monotherapy and combination therapy studies combined) were heavily pre-treated (median of 8 prior therapy regimens). Disease control was seen in 7 of 11 patients (64%) suggesting clinical benefit in this subset of patients. This included 2 of 5 patients with objective responses, both of whom had 2 or more HLA matches with Bria-IMT. Overall survival (OS), collected in 6 patients, was 12.5 months suggesting clinical benefit. In comparison, an OS of 7.2-9.8 months was reported in similar patients in the third line setting (Kazmi S, et al., Breast Cancer Res Treat. 2020).
Capitalizing on these findings, BriaCell has engineered cell lines to express specific HLA alleles allowing a single HLA match with ~99% and a double HLA match with ~90% of the population. These cell lines will provide a personalized approach to cancer immunotherapy that is pre-manufactured rather than prepared individually per patient, eliminating the time and complex manufacturing logistics of other personalized immunotherapies.
A copy of the poster will be posted at the following: View Source