• Early data of BriaCell’s combination study of lead candidate, Bria-IMT™, with KEYTRUDA® (by Merck & Co., Inc.) in advanced breast cancer will be announced at the American Association for Cancer Research (AACR) Annual Meeting in Atlanta, Georgia, on April 3, 2019.
• The combination study commenced in October 2018 and is ongoing, with initial efficacy data for the first six patients to be released; the study primarily measures synergistic effects of the combination on tumor regression and biological response.
• So far, there has been an excellent safety profile for the combination of Bria-IMT™ with KEYTRUDA® in advanced breast cancer patients.
BERKELEY, Calif., and VANCOUVER, British Columbia, March 26, 2019 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, is pleased to announce it is finalizing the analysis of the initial efficacy data of the first six patients in the combination study of its lead candidate, Bria-IMT™, with pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.) in advanced breast cancer. BriaCell plans to press release this data on April 3, 2019, at 8:30 am ET. The information will be issued in coincidence with BriaCell’s poster presentation at the American Association for Cancer Research (AACR) Annual Meeting in Atlanta, Georgia.
Rationale for the combination study of Bria-IMT™ with KEYTRUDA®
In the earlier Phase I/IIa study of Bria-IMT™ (without KEYTRUDA™), BriaCell’s scientists noted that cancer cells and cancer-associated cells in the blood of their patients with advanced breast cancer had PD-L1 molecules on their surfaces. PD-L1 is a protein that lowers immune system activity and may be a way in which the breast cancer evades the immune response induced by Bria-IMT™ treatment. BriaCell launched the combination study of Bria-IMT™ with KEYTRUDA® for advanced breast cancer in October 2018 based on the idea that KEYTRUDA®, which blocks the actions of PD-L1, should further enhance the immune activation of Bria-IMT™ in these patients for the following reasons:
• KEYTRUDA® blocks PD-L1 activity, hence “awakening” a component of the immune system in these cancer patients.
• Bria-IMT™, which ”puts the foot on the gas” of the immune system, should work well with KEYTRUDA® in “awakening” the immune system of the patient, and the combined action of the two may be greater than the sum of their individual effects.
• BriaCell uses a similar concept to that of a preclinical combination study conducted by Dr. James P. Allison’s group, showing reduction in tumor size. Dr. Allison’s findings led to the 2018 Nobel Prize in physiology or medicine.
“The early efficacy data of the first six patients in our Phase I/IIa study of Bria-IMT™ with KEYTRUDA® represents an important milestone for BriaCell as a rapidly advancing company with an innovative technology. Through the combination study, we are learning more about the mechanism of action of our novel immunotherapy, which will aid in assessment of combining Bria-IMT™ with other drugs, including other checkpoint inhibitors,” said Dr. Bill Williams, BriaCell’s president and CEO.
“It is important to note that KEYTRUDA® alone has not been approved for the treatment of advanced breast cancer,” Dr. Williams added.
The details of BriaCell’s AACR poster are as follows:
Abstract Control Number: 3662
Title: Development of a personalized off-the-shelf whole-cell immunotherapy for breast cancer
Session Category: Immunology
Session Title: Immunomodulators and Response to Therapy
Date: Wednesday, April 3, 2019
Time: 8:00 a.m.–noon ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 24
Poster Board Number: 21
Permanent Abstract Number: 4998
Following the presentation, a copy of the poster will be posted on https://briacell.com/investor-relations/presentations/.
About Phase I/IIa Combination Study of Bria-IMT™ with KEYTRUDA® in Advanced Breast Cancer
The FDA has approved the combination study of Bria-IMT™ with KEYTRUDA®, an anti-PD-1 antibody, for patients who show expression of PD-L1 or PD-L2 in their cancer. More information on the combination study of Bria-IMT™ with KEYTRUDA® will be available on ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03328026).
About KEYTRUDA® (pembrolizumab)
Manufactured by Merck & Co., Inc., KEYTRUDA® (pembrolizumab) is a prescription medicine that may treat certain cancers by working with the immune system. It has been approved for the treatment of a number of cancer indications, excluding breast cancer. For more information on pembrolizumab, please see: http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf.
The AACR was founded in Washington, D.C., May 7, 1907, by a group of 11 physicians and scientists intending “to further the investigation and spread the knowledge of cancer.” To prevent and cure cancer using research, education, communication, collaboration, funding and advocacy has been the mission of AACR. With its programs and services, AACR advances research in cancer and related biomedical science by facilitating exchange of knowledge and innovations among scientists and clinicians dedicated to the fight against cancer, providing education and training in oncology treatment and advancing cancer etiology, prevention, early detection, diagnosis and treatment worldwide.
For more information on AACR, please visit: https://www.aacr.org.
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. (NYSE: MRK)]. 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 percent 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: 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.
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