BERKELEY, Calif. and VANCOUVER, British Columbia, May 29, 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 will publish its clinical findings in the American Society of Clinical Oncology (ASCO) Annual Meeting Proceedings. ASCO’s Annual Meeting, taking place June 1-5, 2018 in Chicago, IL, represents the world’s largest gathering of oncology physicians, biotechnology executives, researchers, and investment analysts to discuss breakthrough clinical research and therapeutics in the field.
“We are very excited with our clinical findings, and are delighted that ASCO selected our abstract to be published in their meeting proceedings,” said Dr. Williams, BriaCell’s President and CEO. “The inclusion of BriaCell’s clinical data in the proceedings of such a prestigious meeting lends important support to our hypothesis that Bria-IMT™’s unique mechanism of action may shrink tumors in breast cancer patients who match HLA Class II molecules with Bria-IMT™. The findings also provide a strong rationale for the development Bria-OTS™, BriaCell’s off-the-shelf personalized immunotherapy for advanced breast cancer to match/cover over 90% of the patient population ,” Dr. Williams noted. “We are pleased to announce that we have recently initiated treatment on 7 additional patients in the study, for a total of 13 patients to date. The study continues to enroll rapidly and we look forward to sharing the interim data in the second half of 2018.”
BriaCell is currently conducting the Phase IIa trial (NCT03066947) with Bria-IMT™, and a rollover trial (NCT03328026) with Bria-IMT™ in combination with other immunotherapies. For further information on the Phase IIa trials, please visit https://clinicaltrials.gov/ct2/show/NCT03066947 and https://clinicaltrials.gov/ct2/show/NCT03328026.
The abstract summarizes the clinical data on 6 advanced breast cancer patients dosed with Bria-IMT™ in the ongoing Phase I/IIa clinical study (NCT03066947). The clinical data showed that Bria-IMT™ treatment was safe and well-tolerated. Most importantly, tumor volumes were significantly reduced in 2 of 6 advanced breast cancer patients who have failed a number of prior treatments. These findings are highly significant because these 2 patients matched Bria-IMT™ in specific HLA molecules, providing additional support for our hypothesis for the unique mechanism of action of Bria-IMT™ which sets it apart from similar immunotherapy products, and provides the logic for further development of BriaDX™, BriaCell’s companion diagnostic test.
The details of the abstract are the following:
Category: Developmental Therapeutics—Immunotherapy
Meeting: 2018 ASCO Annual Meeting
Abstract No: e15165
Section: Cancer Immunity and Immunotherapy
Title: SV-BR-1-GM a whole-cell targeted immunotherapy for breast cancer: Preliminary clinical data
The abstract can be accessed via the following link: http://abstracts.asco.org/214/AbstView_214_229215.html.
BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer. Immunotherapy has come to the forefront in the fight against cancer because it uses the body’s own immune system in recognizing and selectively destroying cancer cells while leaving normal cells intact. In addition, immunotherapy is also considered to be a more potent approach than chemotherapy, and has 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. BriaCell believes that Bria-IMT™ helps the body to recognize and kill tumor cells by activating both T cells that directly attack tumor cells, 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 breast cancer that had spread to other sites (metastatic cancer) responded to Bria-IMT™ with a substantial reduction in tumor size and volume in these sites, including sites in the breast, the lung, soft tissues, and even the brain. BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT™ in patients with advanced breast cancer. In this trial, to date, Bria-IMT™ treatment has been safe with instances of tumor reduction observed. 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, to be able to predict the patients who will likely benefit the most from Bria-IMT™ treatments. Additionally, the FDA recently approved a rollover combination study of Bria-IMT™ with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company]. This study permits continuation of the Bria-IMT™ treatment for patients in the ongoing Phase I/IIa trials who stop responding to the treatment. The rollover trial is listed in ClinicalTrials.gov as NCT03328026.
Based on our observation of superior tumor shrinking responses in the patients who shared certain HLA types with Bria-IMT™, BriaCell is developing Bria-OTS™, an off-the-shelf personalized Immunotherapy, for advanced breast cancer. Bria-OTS™ includes a set of cell lines, each being similar to Bria-IMT™, which are being engineered to express various pre-manufactured HLA types. With only 15 different HLA types, Bria-OTS™ cell line combinations are expected to cover over 90% of the United States’ population. BriaCell expects to use BriaDX™ to determine the HLA types of patients, and subsequently select one or two Bria-OTS™ cell lines with matching alleles to be administered to the patient. This should produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense, and complex manufacturing logistics currently used for other personalized immunotherapies. In essence, Bria-OTS™ should provide a personalized treatment without the need for personalized manufacturing.
BriaCell’s small molecule program includes the development of novel, selective protein kinase C delta (PKCδ) inhibitors which have shown potent activity in a number of pre-clinical models of several different cancer indications as well as fibrotic diseases.
For additional information on BriaCell, please visit our website: https://briacell.com.
BriaCell Grants Incentive Stock Options
On May 25, 2018, BriaCell granted incentive stock options to purchase 500,000 shares of the company at CAD$0.20 per share, and 2,015,600 shares of the company at CAD$0.14 per share. The 500,000 options will be exercisable for a period of 4 years and the 2,015,600 will be exercisable for a period of 3 years and are subject to regulatory approval.
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