· Completed development of a novel frozen formulation of Bria-IMT™ for on-demand shipment to clinical sites to accommodate higher patient volumes at reduced per-dose costs.
· Upcoming attendance at Biotech Showcase in San Francisco, Jan. 7-9, 2019.
· Abstract accepted by Keystone Symposia for presentation of advances in Bria-IMT™ and BriaDX™ programs, Jan. 20-24, 2019.
· BriaDX™ is the corresponding companion diagnostic test which helps identify those patients most likely to benefit from Bria-IMT™ and Bria-OTS™.
BERKELEY, Calif., and VANCOUVER, British Columbia, January 2, 2019 – BriaCell Therapeutics Corp. (TSX-V:BCT) (OTCQB:BCTXF) (“BriaCell” or the “Company”), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, today announces the imminent clinical use of a new novel, frozen formulation for its lead product candidate, Bria-IMT™, which is currently being tested in a Phase I/IIa clinical trial with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)], listed in ClinicalTrials.gov as NCT03328026. Additionally, BriaCell will present a poster at a 2019 Keystone Symposia scientific conference, which is being held Jan. 20-24, 2019, at Fairmont Hotel Vancouver in Vancouver, British Columbia. The poster will highlight BriaCell’s recent clinical and research-focused development of Bria-IMT™ and BriaDX™, the corresponding companion diagnostic which helps identify those patients most likely to benefit from Bria-IMT™ and Bria-OTS™. The Company further announces that BriaCell management will attend Biotech Showcase™ 2019, an important investor conference taking place Jan. 7-9, 2019, at Hilton San Francisco Union Square in San Francisco, California.
Novel Frozen Formulation of Bria-IMT™ Approved by FDA for Dosing
The Company’s novel, frozen formulation permits storage of cryopreserved, ready-to-inject Bria-IMT™ and cold-chain overnight transport to the clinical sites where it will be thawed prior to injection in patients with advanced breast cancer. The novel, frozen formulation of Bria-IMT™ has shown improved potency compared to the old formulation in vitro. Long term, the novel, frozen formulation is expected carry reduced per-dose costs compared to the old formulation.
“Currently, the old formulation of Bria-IMT™ used in the clinical trials was cumbersome to prepare, as it had to be processed the day before administration to patients. This created a great deal of inconvenience and complexities for the manufacturer, clinicians and patients,” said Dr. Bill Williams, BriaCell’s President and CEO. “The new frozen formulation has shown improved potency and stability in vitro and, based on its constituents and injection route, is expected to be highly bioavailable. This enhances Bria-IMT™’s potential to address patient needs as a ready-to-use treatment alternative that can be prepared in advance, is easily transportable to distant locations in large quantities, is easy to use, and is safe and highly effective. We are excited to add this novel technology to our growing immunotherapy franchise as we advance safe and effective treatment solutions for advanced breast cancer, an unmet medical need. We look forward to the efficacy data of our ongoing clinical trial, which will provide further evidence for this promising novel therapy to bring hope to patients with advanced breast cancer.”
The Company further announces the completion of its Phase I/IIa trial assessing Bria-IMT™ monotherapy in advanced breast cancer. In total, 23 subjects have been dosed with Bria-IMT™ in this study, three of which have rolled-over to the combination study. Comprehensive data analysis is underway.
BriaCell To Attend Biotech Showcase™ 2019
BriaCell management will be attending Biotech Showcase™ 2019, which will be held Jan. 7-9, 2019, at Hilton San Francisco Union Square (333 O’Farrell St., San Francisco, CA 94102). Dr. Saeid Babaei, BriaCell’s chairman of the board, and Dr. Bill Williams, BriaCell’s President and CEO, will be available for one-on-one meetings from Jan. 7 to Jan. 9, 2019, in San Francisco.
To arrange a one-on-one meeting with BriaCell’s management and the board in San Francisco, please kindly contact:
Manager, Corporate Development
An updated presentation will be available for download at https://briacell.com/investor-relations/presentations/.
Poster Presentation at 2019 Keystone Symposia Conference
BriaCell will present a poster highlighting the Company’s recent clinical and research-focused development on Bria-IMT™, a novel immunotherapy for breast cancer, and BriaDX™, the corresponding companion diagnostic test. Bria-IMT™ activates the immune system to destroy cancer cells in a way believed to be both unique and more effective than other, similar approaches. BriaDX™ helps identify those patients most likely to benefit from Bria-IMT™ and Bria-OTS™, BriaCell’s off-the-shelf personalized immunotherapy, which is under development with plans to enter the clinic in 2H2019.
The details of the poster are as follows:
Poster Number: 2003
Poster Title: SV-BR-1-GM, a breast cancer cell line with features of dendritic cells, induces tumor regression in HLA matched Stage IV breast cancer patients
Session: Poster Session 2
Date: Tuesday, Jan. 22, 2019
Following the presentation, copies of the abstract and the poster will be posted on https://briacell.com/investor-relations/presentations/.
About Biotech Showcase™
Biotech Showcase™ is an investor and networking conference that provides private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this bellwether week, which sets the tone for the coming year.
In addition to biopharmaceutical and life science company executives, Biotech Showcase delegates include investors in private and public companies, sector analysts, bankers and industry professionals. For more information on Biotech Showcase™ 2019, please visit https://ebdgroup.knect365.com/biotech-showcase/.
About Keystone Symposia
Founded in 1972 in Los Angeles as the ICN-UCLA Symposium on Molecular Biology by Professor C. Fred Fox, Keystone Symposia on Molecular and Cellular Biology was evolved as a 501(c)(3) nonprofit organization headquartered in Silverthorne, Colorado, USA. The Symposia organizes open, peer-reviewed conferences across a broad range of the life sciences on six continents: Africa, Asia, Australia, Europe, North America and South America.
The meeting gathers scientists and clinicians from all over the world to network and exchange the cutting-edge scientific findings and technologies in the life science field.
For additional information on 2019 Keystone Symposia, please visit: http://www.keystonesymposia.org/19L2.
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.]. 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.
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For further information, please contact:
BriaCell Therapeutics Corp.:
Manager, Corporate Development