· BriaCell has achieved positive proof of concept in the Phase IIa study of Bria-IMT™ in advanced breast cancer patients
· Data shows promising anti-tumor activity of Bria-IMT™ in heavily pre-treated advanced breast cancer patients
· Impressive Phase IIa efficacy data is similar or superior to those of other approved breast cancer drugs of similar clinical-stage of development
· Outstanding safety and tolerability profile for Bria-IMT™
· Data confirms “HLA Matching Hypothesis” and supports BriaCell’s strategy for the development of Bria-OTS™
· BriaCell has initiated a combination study of Bria-IMT™ with Keytruda (by Merck & Co., Inc.) or Yervoy (by Bristol-Myers Squibb Company)
BERKELEY, Calif. and VANCOUVER, British Columbia, (September 26, 2018) BriaCell Therapeutics Corp. (“BriaCell”, the “Company”) (TSX-V: BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce that it has achieved proof of concept in the Phase IIa study of its lead clinical candidate , Bria-IMT™, in advanced breast cancer. The Company will host a webcast at 4:15 p.m. ET today to discuss these results.
To further enhance the anti-tumor activity of Bria-IMT™, the Company will focus on the combination study of the candidate with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company]. The combination study is listed in ClinicalTrials.gov as NCT03328026.
To date, 31 advanced stage breast cancer patients have been enrolled in the Phase IIa Bria-IMT™ monotherapy study. The Phase IIa confirmatory mechanism of action and proof of concept work is based on the first 20 patients, with assessment of the remaining 11 patients in progress. Given the conclusive findings on the first 20 patients, enrollment for this monotherapy study is now closed, while enrollment for the combination study is open.
“Bria-IMT™ appears to be most effective in patients who match with Bria-IMT™ at 2 HLA loci (types) further supporting BriaCell’s HLA Matching Hypothesis, and the development of Bria-OTS™ to cover 90% of the patient population. We are delighted with these positive clinical findings that confirm our HLA Matching Hypothesis in the Phase I/IIa trial in advanced breast cancer showing significant tumor shrinkage without serious side effects,” stated BriaCell’s President and CEO Dr. Bill Williams. “We believe that combination studies with immune checkpoint inhibitors should create even more potent anti-cancer immune responses, leading to our strategy of combination studies of Bria-IMT™ with Keytruda® or Yervoy®.”
“This top-line data compares very well with data from existing breast cancer therapies which have a sizable market share when they were at a similar stage of clinical development, as well as with other promising breast cancer treatments currently under study. In our view, the combination of Bria-IMT™ with Keytruda® or Yervoy® has the potential to provide a new therapeutic option and substantial clinical benefit in heavily pre-treated advanced breast cancer patients where there remains a significant unmet need.”, Dr. Williams added.
Clinical Data Webcast
Dr. Williams will present Bria-IMT™’s proof of concept clinical data today, September 26, 2018, at 4:15 p.m. ET.
We welcome all our shareholders and prospective investors, partners and patients to attend the Company’s data announcement.
Webcast title: BriaCell Therapeutics Corp. Conference Call
Start time: Wed, Sep 26, 2018 4:15 p.m. ET
Conference ID: 10005555
Participant link (to view the slide presentation): http://public.viavid.com/index.php?id=131478
Participant Dial-In Numbers:
Toll-Free (North America) 1-855-327-6837
Replay Dial-In Numbers:
Toll-Free (North America) 1-844-512-2921
From: 09/26/18 at 7:15 p.m. ET
To: 10/10/18 at 11:59 p.m. ET
Replay Pin Number: 10005555
The presentation will be available for download at: https://briacell.com/investor-relations/presentations/
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.
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.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company]. 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