Material information is being presented concurrent with this press release at 9:35am Eastern Time at the Next Gen Immuno-Oncology Congress. Publicly-traded securities of BriaCell Therapeutics Corp. (TSX-V:BCT) (OTCQB:BCTXF) will remain halted for the duration of CEO Dr. Williams’ presentation.
• Robust responder experienced a highly remarkable reduction in breast cancer tumors in the adrenal gland and the outer lining of the brain – tumors that had metastasized to areas outside of her breasts.
• Prior to the Combination Study of Bria-IMT™ with KEYTRUDA®, she had failed prior regimens with 16 agents (13 chemotherapy and 3 hormonal).
• The patient remains on treatment.
• Additional patient data sets to be presented at the San Antonio Breast Cancer Symposium on December 10-14, 2019.
BERKELEY, Calif., and VANCOUVER, British Columbia, September 19, 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 announces that Dr. Williams, BriaCell’s President & CEO, presented clinical updates of its Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)] in patients with advanced breast cancer at the 2nd Annual Next Gen Immuno-Oncology Congress, taking place at Hilton Garden Inn, Philadelphia Center City. The Combination Study is listed in ClinicalTrials.gov as NCT03328026.
Background
BriaCell had hypothesized that combining Bria-IMT™, which attacks the tumor in a targeted way, with immune “checkpoint inhibitors”, such as KEYTRUDA®, which act by awakening the immune system, would lead to more powerful anti-cancer activity compared to that of Bria-IMT™ alone in advanced breast cancer patients. Along with efficacy data presented today, initial efficacy data for the first six patients of the Combination Study, announced on April 3, 2019, supports BriaCell’s hypothesis.
Remarkable Responder
The top responder (“Remarkable Responder”) in the Combination Study experienced a highly remarkable reduction in breast cancer tumors. She is an advanced breast cancer patient who had failed 12 prior regimens with 16 agents (13 chemotherapy agents and 3 hormonal agents). She showed one of the best immune responses and displayed a highly remarkable reduction in breast cancer tumors (metastases) in the adrenal gland and the outer lining of the brain during the Combination Study. Prior to enrollment in the Combination Study, the Remarkable Responder had progressive cancer in spite of aggressive treatment with some of the newest therapies. She remains on the Combination Study treatment.
BriaCell’s “matching hypothesis” has been further strengthened: The Remarkable Responder matched Bria-IMT™ at 2 HLA loci (HLA-C and HLA-DRB3). BriaCell’s immunotherapy treatment appears most effective when the patient’s HLA-type matches the Bria-IMT™ HLA-type as concluded in prior Phase IIa proof-of-concept work.
The data presented today also noted that the Bria-IMT™ regimen administered with KEYTRUDA® was safe and well tolerated. The women who showed the best clinical responses to the combination of the Bria-IMT™ regimen with KEYTRUDA® also showed the best immune responses including a cellular immune response (i.e. activated T cells that fight the cancer) and a humoral immune response (i.e. produced antibodies that target the tumor cells).
In BriaCell’s view, the presentation of the Remarkable Responder’s tumor reduction required public disclosure to avoid selective disclosure of material information. Rather than reporting incremental patient data going forward, it is BriaCell’s intent to present more fulsome patient data sets at major cancer conferences, such as the San Antonio Breast Cancer Symposium on December 10-14, 2019.
A copy of the presentation document is posted on https://briacell.com/investor-relations/presentations/.
“We are thrilled to see these impressive clinical findings in the Combination Study that confirm our hypothesis of clinical benefit (i.e. tumor shrinkage without serious side effects) in advanced breast cancer patients who had failed multiple prior treatments. In our view, these results support the clinical efficacy (i.e. additive or synergistic effects) that we previously observed in advanced breast cancer patients,” commented Dr. Williams.
“I am very pleased with these exciting findings, demonstrating unprecedented activity of the Bria-IMT™ regimen in combination with KEYTRUDA® in these very heavily pre-treated patients,” noted Dr. Charles Wiseman, BriaCell’s Scientific Founder and Director. “Advanced breast cancer patients, especially those with brain metastases, have very few effective treatment options. While more detailed study is needed, the possibility of shrinking brain-associated metastases is unparalleled. The current novel combination has shown the ability to shrink tumors, improve the quality of the patients’ lives, and perhaps even extend the lifespan of the patients,” Dr. Wiseman added.
About the 2nd Annual Next Gen Immuno-Oncology Congress
The use of immune-based treatments such as antibody drug conjugates, immune checkpoint inhibitors, bispecific antibodies and cell therapies have gained momentum in the past few years making immuno-oncology is one of the hottest fields of biopharma.
The Congress gathers academicians, researchers and scientists from research institutes, pharmaceuticals, bio-pharmaceutical and biotechnology companies to discuss the latest updates in the field of immune-oncology.
For further information on the 2nd Annual Next Gen Immuno-Oncology Congress, please visit: https://events.marketsandmarkets.com/2-annual-marketsandmarkets-next-gen-immuno-oncology-congress/.
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™, BriaCell’s lead candidate, in a Combination Study with immune checkpoint inhibitors such as pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)]. The Combination Study is listed in ClinicalTrials.gov as NCT03328026.
BriaCell also has a non-exclusive clinical trial collaboration with Incyte Corporation to evaluate the effects of combinations of novel clinical candidates. Under the agreement, Incyte and BriaCell will be evaluating novel combinations of compounds from Incyte’s development portfolio with Bria-IMT™ in advanced breast cancer patients.
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: [email protected]
Phone: 1-888-485-6340