– Early Evidence of Safety and Impressive Anti-Tumor Activity of Bria-IMT™-
BERKELEY, Calif. and VANCOUVER, British Columbia, April 10, 2018 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (“BriaCell”) (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, announced today that it has been selected to present a late-breaking poster presentation at the Annual Meeting of the American Association for Cancer Research (AACR) being held on April 14-18, 2018 at McCormick Place North/South, Chicago, Illinois. The poster will highlight the preliminary safety and efficacy of its lead product candidate, Bria-IMT™. Dr. William Williams, BriaCell’s President & CEO, will discuss the latest update on the Company’s clinical trial of Bria-IMT™ in patients with advanced breast cancer. BriaCell is currently enrolling patients in a Phase IIa trial (NCT03066947) with Bria-IMT™ and a rollover trial (NCT03328026) with Bria-IMT™ alone or in combination with other immunotherapies.
Title, location, and time of the poster presentation are as follows:
Title: Safety and efficacy of a whole-cell targeted immunotherapy for breast cancer: Preliminary findings
Session Date and Time: Tuesday Apr 17, 2018 1:00 PM – 5:00 PM (CST)
Location: McCormick Place South, Exhibit Hall A, Poster Section 42
Session Category: Clinical Research
Session Title: Phase I/II, II, and III Trials in Progress
Poster Board Number: 23
Abstract Control Number: 10970
Permanent Abstract Number: CT171
A reference to the abstract can be accessed via the following link: http://www.abstractsonline.com/pp8/#!/4562/presentation/11287 (Abstract embargoed at this time). Following the presentation, copies of the abstract and the poster with be posted on https://briacell.com/investor-relations/presentations/.
The poster will describe preliminary findings on safety and efficacy of Bria-IMT™ in patients enrolled in the ongoing study WRI-GEV-007, “A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients”, listed in ClinicalTrials.gov as NCT03066947, and will evaluate the hypothesis that patients who match Bria-IMT™ for HLA type may have enhanced tumor response to the Bria-IMT™ regimen.
“The results to be presented will add to the growing body of evidence for the clinical utility of Bria-IMT™,” said Dr. Bill Williams. “We are very pleased with the results we have seen to date and look forward to presenting them to the scientific community at AACR. We believe our data supports the use of HLA typing in advanced breast cancer patients to select those most likely to respond to Bria-IMT™, and bolsters our decision to develop Bria-OTS™, the first off-the-shelf personalized immunotherapy for breast cancer, along with, BriaDX™, its companion diagnostic test, to bring hope to advanced breast cancer patients with far too few effective treatment options.”
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: https://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.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information, please contact:
BriaCell Therapeutics Corp.:
Manager, Corporate Development