• As presented at the American Association for Cancer Research (AACR) annual meeting: early efficacy data for the first six advanced breast cancer patients dosed with Bria-IMT™ in combination with KEYTRUDA® suggest additive or synergistic effects on tumor regression (“shrinkage”).
• Findings support BriaCell’s hypothesis: KEYTRUDA® acts by “awakening” a component of the immune system, while Bria-IMT™ “puts the foot on the gas” of the immune system, leading to more powerful anti-tumor activity.
• The combination with KEYTRUDA® appears to overcome the limitation of requiring patients to have an HLA match with Bria-IMT™.
• Excellent overall safety profile for the combination.
• BriaCell intends to advance these findings by accelerating patient dosing with the proceeds from its recently-closed private placement.
BERKELEY, Calif., and VANCOUVER, British Columbia, April 3, 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, today announced early efficacy data of BriaCell’s novel immunotherapy, Bria-IMT™, in combination with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)] (the “Combination Study”) in advanced breast cancer patients. Detailed findings are included below, with early evidence suggesting rapid additive or synergistic anti-tumor activity including examples of tumor reduction at multiple sites and disease stabilization. Additionally, the combination was very safe and well-tolerated in all 6 patients of the study.
BriaCell had hypothesized that combining Bria-IMT™, which “puts the foot on the gas” of the immune system, with immune “checkpoint inhibitors”, such as KEYTRUDA®, which act by “awakening” a component of the immune system, would lead to more powerful anti-cancer activity compared to Bria-IMT™ alone. Initial efficacy data for the first six patients supports BriaCell’s hypothesis. For Bria-IMT™ alone in monotherapy study, HLA matching between the patient and Bria-IMT™ appeared to be important for the development of anti-cancer activity, but the combination with KEYTRUDA® appears to overcome this limitation.
Summary of Early Data of Bria-IMT™ with KEYTRUDA® Combination Study
• All 6 patients were very heavily pre-treated with a median of 5 prior systemic therapy regimens (such as chemotherapy) prior to enrollment in BriaCell’s Combination Study.
• These patients previously did not respond to a number of currently available therapies outside of BriaCell, and most had very weak immune systems, further emphasizing the importance of the positive results observed in BriaCell’s Combination Study.
Four patients rolled-over from BriaCell’s Bria-IMT™ monotherapy study:
• Top Responder: One woman with stable disease on monotherapy had been on 8 prior chemotherapy regimens and had extensive tumor growth in her liver. She experienced a 43% reduction in the size of her liver metastases within 2 months and continues on the Combination Study.
o She had a tumor type that typically does not respond to KEYTRUDA® alone, suggesting distinct benefits by the Combination Study.
o Of note, she is not an HLA match with Bria-IMT™ suggesting that the combination with KEYTRUDA® may not require a ‘match with Bria-IMT™’ to result in tumor reduction. Consequently, the Combination Study regimen may work for patients regardless of HLA matching.
• Three women had progressive disease prior to the Combination Study – they were only dosed for a short time, and either discontinued the treatment or showed progressive disease. They had very weak immune systems and very advanced cancer prior to BriaCell’s Combination Study.
Two patients entered the Combination Study directly without previous Bria-IMT™ treatment:
• One woman achieved stable disease, in spite of 9 prior anti-cancer regimens (including 6 chemotherapy regimens and 3 biological therapy regimens) and therefore appears to have derived clinical benefit from the combination treatment. She matched Bria-IMT™ at one HLA allele (“type”).
The combination was very safe and well-tolerated in all 6 patients of the study.
“Early results from the Combination Study of Bria-IMT™ with KEYTRUDA® in advanced breast cancer have revealed that anti-tumor activity of BriaCell’s novel immunotherapy, Bria-IMT™, can be further enhanced with KEYTRUDA®,” stated Dr. Bill Williams, BriaCell’s president and CEO. “We are impressed with the early data of the Combination Study, suggesting efficacy and clinical benefits in a heavily-treated, difficult to treat patient population. One woman for example experienced a robust immune response to Bria-IMT™ before starting the combination study, and her tumor-reduction response to Bria-IMT™ was significantly enhanced when Bria-IMT™ was combined with KEYTRUDA®. We look forward to the continuation of the Combination Study and hope to be able to offer better treatment solutions for advanced breast cancer patients. We would like to thank our consultants and patients who make these findings possible in the fight against this devastating disease.”
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 with advanced breast 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 99 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: https://briacell.com/.
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