· Grant awarded to Dr. Saveri Bhattacharya, Principal Investigator of the Phase I/IIa combination study of Bria-IMT™ with KEYTRUDA® (by Merck) in advanced breast cancer at Thomas Jefferson University.
· Merck to provide KEYTRUDA® for use in the combination study.
· The Investigator Grant validates and will build on the encouraging preliminary data from BriaCell’s combination study of Bria-IMT™ with KEYTRUDA® (Link).
BERKELEY, Calif., and VANCOUVER, British Columbia, February 11, 2020 — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, today announced that Dr. Saveri Bhattacharya, a board-certified medical oncologist and recognized expert in breast cancer treatment at the Sidney Kimmel Cancer Center – Jefferson Health in Philadelphia, PA, has been selected to receive support from the Merck Investigator Studies Program (“MISP”). The Investigator Grant is a highly coveted award granted by Merck & Co., Inc. (“Merck”) (NYSE: MRK) to leading investigators with highly innovative clinical studies.
The clinical study being supported is a Phase I/IIa study of BriaCell’s lead clinical candidate, Bria-IMT™, in combination with pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.). Merck will provide KEYTRUDA® for use in the combination study. Patients who match with Bria-IMT™ at least at one HLA type will be eligible for the trial.
Dr. Saveri Bhattacharya is an Assistant Professor of Medical Oncology at Thomas Jefferson University, a member of the NCI-designated Sidney Kimmel Cancer Center – Jefferson Health, a board-certified oncologist experienced in clinical trials in gynecologic oncology and women’s cancers, and a recognized expert in the field of breast cancer treatment. She graduated from Touro University College of Osteopathic Medicine in 2011 and completed her residency in Internal Medicine and fellowship in Hematology/Oncology at The University of Pittsburgh Medical Center. She is currently focused on the clinical trial development in women’s cancers. Dr. Bhattacharya has an impressive list of publications to her credit, including major review articles in both breast cancer chemotherapy and immunotherapy.
The following summarizes the details of the study:
Study Title: A Phase I/II Study of the SV-BR-1-GM Regimen in HLA matched Metastatic Breast Cancer Patients in Combination with Pembrolizumab
Principal Investigator: Saveri Bhattacharya, D.O.
Title: Assistant Professor
Location: Thomas Jefferson University, Sidney Kimmel Cancer Center, Department of Medical Oncology, 1025 Walnut Street, College Building, Suite 700, Philadelphia, PA 19107
“We congratulate Dr. Bhattacharya on receiving this highly competitive award that will accelerate evaluation of the combination of Bria-IMT™ with KEYTRUDA®, which we believe has the potential to create potent anti-tumor immune responses,” stated Dr. Bill Williams, BriaCell’s President and CEO. “We are delighted to collaborate with Merck, Dr. Bhattacharya and her clinical team regarding our shared, enduring commitment to delivering novel therapies to advanced breast cancer patients, a very important unmet medical need.”
“This collaboration is an important step in the continued validation of BriaCell’s innovative immuno-oncology program,” commented Dr. Charles Wiseman, BriaCell’s Scientific Founder and Director. “We look forward to combining our expertise with the strong scientific and clinical expertise of Dr. Bhattacharya and her team to advance the clinical development of our immunotherapies. We are thankful to Merck for its support as we continue to advance our clinical programs to bring hope to advanced breast cancer patients and their families.”
Rationale for the combination study of Bria-IMT™ with KEYTRUDA®
In late 2018, BriaCell announced positive proof of concept data in a Phase I/IIa study of Bria-IMT™ in advanced breast cancer, demonstrating excellent safety and efficacy in patients with HLA matches with Bria-IMT™ (Link). Impressively, the safety and efficacy data appeared similar or superior to that of other advanced or approved drugs for breast cancer when they were at a similar stage of clinical development.
Analysis of blood samples collected in the Phase I/IIa study showed that circulating tumor-associated cells expressed the immune checkpoint molecule programmed death-ligand 1 (“PD-L1”). PD-L1 molecules prevent immune cells from attacking cancer cells. KEYTRUDA® blocks PD-1, which activates PD-L1, and hence promotes the anti-tumor activity of the immune cells. Immune checkpoint inhibitors, such as pembrolizumab (KEYTRUDA®; anti-PD-1), are designed to improve immune activity in cancer patients. These have come to the forefront in the fight against cancer with substantial benefits for some patients.
KEYTRUDA® Combination: BriaCell launched the combination study of Bria-IMT™ with KEYTRUDA® for advanced breast cancer in October 2018 hypothesizing that KEYTRUDA®, which blocks the actions of PD-L1, hence “awakening” a component of the immune system, may further enhance the immune activation of Bria-IMT™ in patients. The combined action may be greater than the sum of their individual effects. Patients will be treated with the combination of Bria-IMT™ and the anti-PD-1 antibody, KEYTRUDA®. BriaCell has already presented encouraging preliminary data (Link) that suggest synergistic and/or additive anti-tumor activity of the combination. In September 2019, BriaCell announced a Remarkable Responder in the combination study of Bria-IMT™ with KEYTRUDA® (Link). The study was subsequently modified to use a combination of Bria-IMT™ with the Incyte PD-1 inhibitor (INCMGA00012) and epacadostat. The combination with KEYTRUDA® was discontinued.
Jefferson, located in the greater Philadelphia region and southern New Jersey, is reimagining health care and education to create unparalleled value. Jefferson is more than 30,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients, preparing tomorrow’s professional leaders for 21st century careers, and discovering new treatments to define the future of care. Thomas Jefferson University, home of Sidney Kimmel Medical College, dates back to 1824 and today comprises 10 colleges and three schools offering 160 undergraduate and graduate programs to more than 8,100 students. Jefferson Health serves patients through millions of encounters each year at 14 hospitals (seven are Magnet® designated by the ANCC for nursing excellence) and over 40 outpatient and urgent care locations throughout the region.
BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer.
BriaCell is conducting a Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with immune checkpoint inhibitors such as the Incyte drugs INCMGA00012 (an anti-PD-1 antibody similar to pembrolizumab [KEYTRUDA®; manufactured by Merck & Co., Inc. (NYSE: MRK)]) and epacadostat, an orally bioavailable small-molecule inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1). The combination study is listed in ClinicalTrials.gov as NCT03328026.
BriaCell currently 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 BriaCell’s drug candidates in advanced breast cancer patients.
BriaCell is also 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.
For further information, please contact:
BriaCell Therapeutics Corp.:
Manager, Corporate Development