· Patient dosing is underway in a combination study of Bria-IMT™ with KEYTRUDA® (by Merck & Co., Inc.) or YERVOY® (by Bristol-Myers Squibb Company) in advanced breast cancer.
· KEYTRUDA® and YERVOY® have been highly recognized for their potent immune boosting properties – Nobel Prize in Medicine 2018 – validating BriaCell’s strategy to use these therapeutics in its combination study.
· Interim combination study safety profile expected in 4Q 2018.
· BriaCell recently announced positive proof of concept data in the Phase I/IIa study of Bria-IMT™ in advanced breast cancer patients indicating excellent targeted anti-tumor activity and outstanding safety and tolerability.
BERKELEY, Calif. and VANCOUVER, British Columbia, Oct. 9, 2018 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (“BriaCell”, the “Company”) (TSX-V: BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that it has initiated patient dosing in a Phase I/IIa study of its lead clinical candidate, Bria-IMT™, in combination with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)] or ipilimumab [YERVOY®; manufactured by Bristol-Myers Squibb Company (NYSE: BMY)]. The combination study is listed in ClinicalTrials.gov as NCT03328026.
“We believe that combination of Bria-IMT™ with immune checkpoint inhibitors should create even more potent anti-cancer immune responses, leading to our strategy of combination studies of Bria-IMT™ with KEYTRUDA® or YERVOY®,” stated BriaCell’s President and CEO, Dr. Bill Williams. “BriaCell is committed to exploring additional ways to address the unmet needs of the advanced breast cancer community. We are very excited to test this novel combination treatment approach which we believe will offer significant clinical benefit to patients with advanced breast cancer.”
On Sept. 26, 2018, BriaCell announced positive proof of concept data in a phase I/IIa study of Bria-IMT™ in advanced breast cancer with outstanding safety and efficacy in patients with HLA matches with Bria-IMT™. Impressively, the safety and efficacy data appeared superior to that of other advanced or approved drugs for breast cancer when they were at a similar stage of clinical development.
Analysis of blood samples collected in the phase I/IIa study showed that circulating tumor-associated cells expressed the immune checkpoint molecule programmed death-ligand 1 (PD-L1). PD-L1 molecules block immune cells from attacking cancer cells. KEYTRUDA® neutralizes the blocking mechanism of PD-L1 while YERVOY® blocks other aspects of immune suppression and as such may also activate the immune system to destroy cancer cells.
• KEYTRUDA® Combination: Patients with expression of PD-L1 or PD-L2 will be treated with the combination of Bria-IMT™ and the anti-PD-1 antibody KEYTRUDA®.
• YERVOY® Combination: Patients without expression of PD-L1 or PD-L2 will be treated with the combination of Bria-IMT™ and YERVOY®, which is also expected to boost the immune response induced by Bria- IMT™.
BriaCell team hypothesizes that patients in the combination therapy trial may derive particular benefit from these combinations with Bria-IMT™.
Rationale for the combination study of Bria-IMT™ with KEYTRUDA® or YERVOY®
Immune checkpoint inhibitors such as pembrolizumab (KEYTRUDA®; anti-PD-1) and ipilimumab (YERVOY®; anti-CTLA-4), designed to overcome immune suppression in cancer patients, have come to the forefront in the fight against cancer with substantial benefits for some patients. Most recently, the significance of immune checkpoint inhibitors was recognized by the Nobel committee by awarding Dr. Tasuku Honjo (PD-1) and Dr. James P. Allison (CTLA-4) the 2018 Nobel Prize in Physiology or Medicine (Scientists behind game-changing cancer immunotherapies win Nobel medicine prize), validating the Company’s decision to launch a combination therapy with the immune checkpoint inhibitors.
In 2010, an important pre-clinical study by Dr. Allison’s group showed that combination with anti-PD-1 and anti-CTLA-4 antibodies potentiated the tumor-rejection effect of irradiated melanoma cells engineered to produce immune-activating factors.
Bria-IMT™, in essence a breast cancer cell line engineered to produce an immune-activating factor (GM-CSF), has been shown to stimulate T cells, i.e., important cells of the immune system. BriaCell has published these findings in a leading immunology journal earlier this year. Based on the published, proposed mechanism of action of Bria-IMT™, the Company envisions that Bria-IMT™ and immune checkpoint inhibitors can exert additive or synergistic tumor-directed effects. It is important to note that pembrolizumab and ipilimumab have not been shown to work on their own in breast cancer but are approved for other indications.
BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.
BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT™, its lead candidate, in a combination study with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc.] or ipilimumab [YERVOY®; manufactured by Bristol-Myers Squibb Company]. The combination study is listed in ClinicalTrials.gov as NCT03328026.
BriaCell is developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS™ immunotherapy treatments are personalized to match the patient without the need for personalized manufacturing. Bria-OTS™, which is expected to cover over 90% of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense, and complex manufacturing logistics associated with other personalized immunotherapies.
For additional information on BriaCell, please visit website: http://www.BriaCell.com
Cautionary Note Regarding Forward-Looking Information
Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com.
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