147 0 Kommentare BriaCell Announces Clinical Data as Presented at the 2019 San Antonio Breast Cancer Symposium

Safety and early efficacy data were presented on December 12^th at 6:00 p.m. ET from the clinical trials of Bria-IMT in combination with immune checkpoint inhibitors in advanced breast cancer:

Continued additive or synergistic activity observed in combination study of Bria-IMT with pembrolizumab (KEYTRUDA; by Merck & Co., Inc.) as evident by tumor shrinkage even in the absence of “HLA Matching”.
Additional potential selection criteria identified: women with moderately-well differentiated tumors had a higher response rate.
First patient data from Bria-IMT in combination with INCMGA00012 (from Incyte Corporation).

BERKELEY, Calif., and VANCOUVER, British Columbia, Dec. 13, 2019 (GLOBE NEWSWIRE) -- 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, is pleased to announce the presentation results of clinical studies with its lead product candidate, Bria-IMT, summarized in two poster sessions during the 2019 San Antonio Breast Cancer Symposium (SABCS).

The December 12^th poster summarized data of the Bria-IMT monotherapy study 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 INCMGA00012, in advanced breast cancer. The December 13th poster presentation this evening will address early predictors of effectiveness of the Bria-IMT regimen in advanced breast cancer.

Details and results on the poster presentations are summarized below:

Presentation Title: Efficacy and safety of a modified whole tumor cell targeted immunotherapy in patients with advanced breast cancer alone and in combination with immune checkpoint inhibitors
Session Date: Thursday, December 12, 2019 at 6:00 p.m. ET
Summarized Data:

Eleven patients enrolled in the combination of the Bria-IMT regimen with KEYTRUDA. Of 10 women with data available, BriaCell reasonably anticipated a response in 3 patients after assessment of immune response capability, HLA match and tumor differentiation (described further below). Tumor shrinkage was noted in 2 of these 3 patients.
The remarkable responder treated with the combination of Bria-IMT with KEYTRUDA disclosed on September 19, 2019 remains on study, and she has now transitioned to combination with Incyte’s INCMGA00012 – she had a 26% reduction in the breast cancer tumor size in the adrenal gland, and a 35% tumor size reduction in all tumor sites.
Tumor reduction in Bria-IMT and KEYTRUDA combination in a patient without HLA matching as disclosed on April 3, 2019. Notably this patient had a moderately well-differentiated tumor.
Analysis of the combination study data indicates that women with tumors that are moderately-well differentiated (that look more like normal breast tissue) have a high rate of tumor shrinkage (25% or more tumor shrinkage in 2 of 3 patients). Notably, the Bria-IMT cell line was derived from a patient who ALSO had a moderately-well differentiated tumor. This points to a new way to select the patients most likely to respond in addition to our HLA matching hypothesis.
Reanalysis of BriaCell’s 2018 monotherapy study data shows that, of 6 patients with moderately or well differentiated tumors, 2 of the 6 had definite tumor shrinkage. Two of the 6 patients had 2 or more HLA matches; the same 2 with definite tumor shrinkage.
Initial information on the first patient treated with the combination of the Bria-IMT regimen with INCMGA00012 shows no serious adverse events and preliminary clinical benefit. Recruitment is ongoing.