- 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 03, 2019 (GLOBE NEWSWIRE) -- 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.
Efficacy Data
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.
- She had a tumor type that typically does not respond to KEYTRUDA® alone, suggesting distinct benefits by the Combination
Study.
- 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”).
Safety Data
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.
About AACR
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.
About BriaCell
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/.
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.
Contact Information
For further information, please contact:
BriaCell Therapeutics Corp.:
Farrah Dean
Manager, Corporate Development
Email: Farrah@BriaCell.com
Phone: 1-888-485-6340
