BERKELEY, Calif. and VANCOUVER, British Columbia, June 21, 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 provide a Corporate Update on its activities and new developments, including positive Phase IIa safety information, discovery of tumor shrinkage mechanism, and patient enrollment acceleration.
Dr. Williams, BriaCell’s President & CEO, will be available to answer questions following the presentation on:
Date: June 28, 2018 at 11:00 AM ET
United States: 1-303-248-0285
Access Code: 5147677
Webinar Access (at the time of event): http://www.readytalk.com/join (Access code: 5147677)
• The latest updates on BriaCell’s Phase IIa clinical study of its lead candidate, Bria-IMT™, in advanced breast cancer (NCT03066947).
• Exciting progress in the development of Bria-OTS™, BriaCell’s first off-the-shelf personalized immunotherapy treatment for advanced breast cancer.
• Promising early insights into the novel mechanism of action of Bria-IMT™, also referred to as SV-BR-1-GM. This may explain the impressive early clinical data including tumor shrinkage observed in some patients with advanced metastatic breast cancer, and form the path for the development of Bria-DX™, BriaCell’s Companion Diagnostic Test.
• Recent acceleration in the patient enrollment due to increased number of clinical sites, and expected interim data in 2H2018.
• The latest on the rollover trial (NCT03328026) with Bria-IMT™ in combination with other immunotherapies.
• Advancements in BriaCell’s R&D pipeline.
• Proposed plans for strategic alliances.
“We are very excited to have hit several important milestones for BriaCell and want to share our plans and the key objectives coming up. Our development of a novel personalized targeted immunotherapy that is off-the-shelf without the costs associated with other personalized approaches positions BriaCell to revolutionize the treatment of advanced breast cancer patients. This novel targeted approach and the excellent safety profile we have seen to date should make BriaCell an attractive collaborator for a large number of large and medium sized pharmaceutical companies focusing on immuno-oncology. We will continue to work tirelessly to improve patient outcomes in the fight against this deadly disease, ” stated Dr. Williams, BriaCell’s President & CEO.
We welcome all our shareholders and prospective investors, partners and patients to attend the Company’s corporate update.
The presentation will be available for download at http://briacell.com/investor-relations/presentations/.
The Company also announces that an analyst’s research report has been released by the US-based consulting firm, RB Milestone Group, LLC (“RBMG”). The report provides an in-depth overview of the Company’s product candidate and clinical development updates. It also provides an investment rationale, SWOT analysis, and an overview of the dynamics of the oncology sector trends.
A copy of the research report can be accessed by visiting the homepage of BriaCell’s corporate website (http://briacell.com/category/recent-events/) or by directly contacting Trevor Brucato, Managing Director at RBMG (firstname.lastname@example.org).
For further information, please contact the Farrah Dean, Manager, Corporate Development at Phone: 1-888-485-6340.
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: http://briacell.com.
About RB Milestone Group, LLC
RB Milestone Group, LLC (“RBMG”) is a US-based capital markets consulting firm with offices in Stamford, CT and New York, NY. RBMG provides advisory services in corporate strategy, investor awareness, business development, market intelligence and research to small and venture-stage companies globally. RBMG is known for its deep-rooted contacts amongst high net worth individuals, small funds, family offices, brokers and strategics within the United States. Staff specialists have diverse sector knowledge centered on capital markets. Website: www.rbmilestone.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