– Early data points to safety and early efficacy of Bria-IMT™ in Advanced Stage IV Breast cancer –
BERKELEY, Calif. and VANCOUVER, British Columbia, April 18, 2018 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (“BriaCell”) (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that it has presented two posters highlighting its most recent scientific and clinical findings of BriaCell’s lead product candidate, SV-BR-1-GM, also known as Bria-IMT™, at the 2018 American Association of Cancer Research (AACR) Annual Meeting. The posters are available for viewing at http://briacell.com/category/recent-events/.
The following summarizes the important highlights from the posters:
SV-BR-1-GM, a Whole-Cell Targeted Immunotherapy for Breast Cancer: Preliminary Clinical Data
Led by Dr. Jarrod P. Holmes, of Saint Joseph Heritage Healthcare, Santa Rosa, and the clinical team at BriaCell and Cancer Insight, the poster presentation provided data from the Bria-IMT™ Phase I/IIa clinical trial (listed in ClinicalTrials.gov as NCT03066947). The presentation demonstrated that Bria-IMT™, delivered as a monotherapy regimen along with other immune system modulators, generated immune responses, and tumor reduction in some patients. Specifically, the data showed the following:
• The regimen produced clinically relevant regression of metastases (i.e. cancer that has spread to other sites) in patients with advanced Stage IV breast cancer
• Response was rapid and were fully developed by 3 months and durable at 6 months
• The responses developed despite previous chemotherapy with multiple different regimens
• The regimen appeared to be safe and well-tolerated
• The tumor reduction responses appeared most pronounced in patients who match with Bria-IMT™ at one or more HLA loci
This has encouraged BriaCell to study futher the Bria-IMT™ regimen, specifically in combination therapy with immune checkpoint inhibitors such as pembrolizumab or ipilimumab. The roll-over combination study of Bria-IMT™ with pembrolizumab or ipilimumab is available for patients previously treated with Bria-IMT™ in the Company’s ongoing Phase I/IIa clinical trial in advanced breast cancer. The roll-over trial is listed in ClinicalTrials.gov as NCT03328026.
Targeted immunotherapy with SV-BR-1-GM: Mechanism of action and companion diagnostic development
Lead by Markus D. Lacher, PhD, BriaCell’s Head of R&D, the poster presentation provided information regarding the mechanism of action of Bria-IMT™. The data showed the following:
• Tumor regressions were observed, especially in breast cancer patients matching at HLA-DRB3 with Bria-IMT™.
• Anti-SV-BR-1 antibody levels change with Bria-IMT™ treatment suggesting additional paths for tumor attack.
• Interleukin (IL)-8 levels increased in HLA-DRB3 matched subjects suggesting a potentially higher-level anti-tumor activity in patients who match Bria-IMT™ at HLA-DRB3.
“We are intrigued by the initial data indicating safety and efficacy of Bria-IMT™ in patients with advanced breast cancer, and we look forward to use these findings in the development of Bria-OTS™, our off-the-shelf personalized immunotherapy treatment for advanced breast cancer, which is expected to cover about 95% of the patient population,” stated Dr. Bill Williams, BriaCell’s President & CEO.
BriaCell is an immuno-oncology focused biotechnology company developing a targeted and safe approach to the management of cancer. Immunotherapy has come to the forefront in the fight against cancer, harnessing the body’s own immune system in recognizing and selectively destroying cancer cells while sparing normal ones. Immunotherapy, in addition to generally being more targeted and less toxic than commonly used types of chemotherapy, is also thought to be a potent approach with the potential to prevent cancer recurrence.
Bria-IMT™ (SV-BR-1-GM), the Company’s lead product candidate, is derived from a specific breast cancer cell line. It is genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. We believe that Bria-IMT™ helps the body to recognize and kill tumor cells by activating T cells that attack the tumor and B cells that produce anti-tumor antibodies.
The results of two previous proof-of-concept clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with Bria-IMT™) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to Bria-IMT™ with substantial reduction in tumor burden including breast, lung, soft tissue and brain metastases. BriaCell is currently conducting a Phase I/IIa clinical trial for Bria-IMT™ in patients with advanced breast cancer. In this trial, Bria-IMT™ treatment appeared safe with similar instances of tumor reduction as those observed in the earlier proof-of-concept trials. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDX™, the Company’s companion diagnostic test. Additionally, the FDA recently approved the roll-over combination study of Bria-IMT™ with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company] for patients previously treated with Bria-IMT™ in the Company’s ongoing Phase I/IIa clinical trial in advanced breast cancer. The roll-over trial is listed in ClinicalTrials.gov as NCT03328026.
BriaCell is also developing Bria-OTS™, an off-the-shelf personalized Immunotherapy. Bria-OTS™ is a set of cell lines similar to Bria-IMT™ which are being engineered to express pre-manufactured HLA alleles. With a combined total of 15 different alleles Bria-OTS™ is expected to be able to match more than 90% of the US population. BriaCell’s BriaDX™ companion diagnostic reveals patient HLA types. One or two Bria-OTS™ cell lines carrying matching alleles are planned to be administered per patient. Bria-OTS™ eliminates the complex manufacturing logistics required for other personalized immunotherapies and is regarded as a personalized therapy without the need for personalized manufacturing.
Yet another item in the BriaCell pipeline is a novel, selective protein kinase C delta (PKCδ) inhibitor. PKCδ inhibitors have shown activity in a number of pre-clinical models of RAS genes’ transformed cancers including breast, pancreatic, non-small cell lung cancer and neuroendocrine tumors (such as carcinoid tumors).
For additional information on BriaCell, please visit our website: http://briacell.com.
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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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