Full Press Release Details
Summarizes Clinical Data Poster Presented at the 2021 San Antonio Breast Cancer Symposium
YORK and VANCOUVER, British Columbia, December 9, 2021- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell"
or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast
cancer and other cancers, presented clinical results from its lead clinical candidate Bria-IMT in a poster session held on December
8, 2021 during the 2021 San Antonio Breast Cancer Symposium (SABCS) (the "Poster").
Poster submission was accepted by SABCS on September 15, 2021 and summarized the previously-disclosed Phase I/IIa clinical and pathological
data from the clinical studies of the Bria-IMT regimen alone (the monotherapy studies) and the ongoing Phase I/IIa clinical study
of Bria-IMT in combination with immune checkpoint inhibitors, including pembrolizumab (KEYTRUDA ; manufactured by Merck &
Co., Inc.) and, more recently, Incyte's checkpoint inhibitor, retifanlimab.
Title: Overall Survival following treatment with a modified whole tumor cell targeted immunotherapy in patients with advanced breast
Date: 5:00 - 6:30 p.m. CT on Wednesday, December 8, 2021
Title: Poster Session 2
Data: Thirty-four advanced breast cancer patients were treated with the Bria-IMT regimen: 26 in two monotherapy studies (the
Bria-IMT regimen alone) and 12 in the combination study, with four patients transitioning from monotherapy to the combination
had been heavily pre-treated and had a median of five or greater prior regimens.
The treatment was generally safe and well tolerated in both the monotherapy and the combination studies.
Control: The disease control rate was 25% (n=4) and 30% (n=23) for the monotherapy studies and 33% (n=12) for the combination
study. Complete tumor reduction of selected tumors was observed in several patients, including those with 2+ HLA loci matches with Bria-IMT
and Grade I/II (i.e. moderately-well differentiated) tumors. For the evaluable Grade I/II patients, disease control was seen in 1/2 and
4/6 patients in the monotherapy studies and 3/4 patients in the combination study. This included two patients with partial responses
(PR) according to RECIST criteria. Both patients with PR responses matched Bria-IMT at 2 HLA loci and both had Grade II disease,
matching the tumor grade of the tumor Bria-IMT was derived from.
Cells with HLA (human leukocyte antigen) molecules on their surface determine and trigger
the body's immune response. BriaCell's immunotherapy treatment appears most effective when the patient's HLA-type matches
with Bria-IMT , allowing BriaCell to potentially identify patients most likely to respond. HLA-typing is a simple and widely available
Grade: BriaCell has noted clinical benefit in its patients with grade I and grade
II tumors, suggesting another subgroup of patients for whom BriaCell's treatment would be most effective.
| BriaCell Treatment 1 | Leading Treatment Comparison 2 | |||||||||||
| N = | Filter | Number of Prior Regimens | Overall Survival (Months) | vs. | Number of Prior Regimens | Overall Survival (Months) | ||||||
| 7 | Combination Therapy only | 9 | 12.0 | 2 | 7.2 - 9.8 | |||||||
| 9 | 1+ HLA | 8 | 12.1 | |||||||||
| 5 | 2+ HLA | 5 | 13.4 | |||||||||
| 6 | Tumor Grade I/II | 12 | 12.5 | |||||||||
| Patient 06-005 3 | 2 HLA Tumor Grade II | 13 | 21.4 |
BriaCell treats severely sick patients, as indicated by the "Prior Regimens" column. Patients from both the monotherapy and
combination therapy are included unless otherwise indicated.
Overall survival of 7.2-9.8 months in similar patients with metastatic breast cancer who have failed two prior therapy attempts (i.e.,
third line setting); Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17.
Remarkable Responder highlighted; included within subsets "Tumor Grade I/II" and "2+ HLA".
summary, the overall survival was much higher in the patients in the combination study, suggesting an additive or synergistic effect
and supporting our strategy of continuation with the combination study. The data supports both clinical and survival benefits in the
patients who match Bria-IMT at one or more HLA loci and those with Grade I/II tumors in the combined studies, supporting the importance
of these factors in the treatment efficacy and focusing on these subgroups of patients in the ongoing combination study.
copy of the Poster will be posted on the Company's website here: https://briacell.com/novel-technology/scientific-publications/.
BriaCell Therapeutics Corp.
is an immuno-oncology focused biotechnology company developing targeted and effective approaches for the management of cancer. More information
is available at https://briacell.com/.
press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements,
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"Risks and Uncertainties" in the Company's most recent Management's Discussion and Analysis, under "Risks
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Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty
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