BERKELEY, Calif. and VANCOUVER, British Columbia, Sept. 14, 2017 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, is pleased to provide an update on its collaborative and internal research as well as manufacturing activities.
The Company has recently initiated a research collaboration with Dr. Maurizio Provenzano, MD, PhD, based at the University of Zurich, Switzerland. Objective of this collaboration is to assess, among others, whether a novel type of immune stimulator predicted to home to sites of malignant disease has additive or synergistic effects in combination with BriaVax™, a whole-cell vaccine for breast cancer. “This collaboration offers an exciting opportunity to develop novel immuno-oncology drugs predicted to turn on cancer-fighting T cells,” commented Dr. Markus Lacher, BriaCell’s head of R&D. “In contrast to conventional immune checkpoint inhibitors, the proprietary drug type is designed to activate more selectively the T cells with an actual potential to destroy the patients’ tumors and consequentially to turn on lower numbers of side effect-causing T cells with other specificities,” he continued.
A critical part of the Company’s product development efforts is the oversight of BriaVax’s manufacturing in external facilities that follow Good Manufacturing Practice (GMP). As such, to facilitate clinical trial logistics, KBI Biopharma, Inc. (The Woodlands, TX), one of two manufacturing sites for BriaVax™, is developing a novel formulation of the vaccine permitting cold-chain (dry ice or colder) transport to the clinical sites and stockpiling of fully formulated vaccine at the clinical sites or in nearby locations. The current formulation of BriaVax™ is available at the UC Davis GMP Facility (Sacramento, CA) and requires transport at 2-8°C to the clinical sites where it needs to be inoculated within 24 hours after completion of the formulation process.
BriaCell’s Internal R&D Activities In Berkeley, CA Laboratory
BriaCell’s internal R&D expansion included the hiring of Ms. Sanne Graeve as a Senior Research Associate. Ms. Graeve acts as BriaCell’s laboratory manager. Of note is her experience with Cell Therapy at the Universitair Medisch Centrum (UMC) Utrecht in the Netherlands where she – following GMP procedures – prepared different cell products used for the treatment of patients.
For strong anti-tumor activity, it is believed that BriaVax™ needs to release granulocyte macrophage colony-stimulating factor (GM-CSF). The Company has recently cloned BriaVax™ and is currently expanding numerous clones to obtain greater cell numbers for GM-CSF testing. Selected clones are planned to undergo further expansion to develop master cell banks and eventually clinical product. It is envisioned that such BriaVax™ clones will maintain a lower degree of lot-to-lot variability and perhaps more potent anti-tumor activity than current-day BriaVax™.
In another project, the Company is developing additional whole-cell breast cancer vaccines based on the SV-BR-1 cell line, which is the parent cell line of BriaVax™. These additional vaccines are predicted to simplify the individual treatment cycles requiring fewer patient visits and lowering costs. Additionally, certain features are planned to target breast cancer patient populations with particular immunologic properties that might not receive optimal benefits from the current version of BriaVax™. The hands-on aspects of this “next-gen BriaVax™” project have recently been initiated with the generation of plasmids carrying the first two genes of interest by a commercial fee-for-service vendor. These plasmids are expected to be utilized for cell line engineering at the Company’s Berkeley, CA laboratory by the end of September 2017.
To transition to bioreactor-based, high-yield manufacturing, in yet another project, BriaVax™ cells are being evaluated for their ability to multiply under new culture conditions. In particular, cells have been successfully cultured in serum-free medium, a first step for commercial large-scale production as nonadherent cultures. This is important for the planned commercial production of BriaVax™.
The Company’s Berkeley laboratory is also suited to establish assays to measure biomarkers in the blood of patients participating in the Company’s Phase I/IIa clinical trial for advanced breast cancer (ClinicalTrials.gov identifier: NCT03066947). At this point, one such assay – aimed at quantitating antibodies binding to BriaVax™ in patient blood – is under establishment with encouraging preliminary results.
BriaCell is an immuno-oncology focused biotechnology company developing a targeted and safe approach to the management of cancer. BriaCell’s mission is to serve late-stage cancer patients with no available treatment options.
Immunotherapy has come to the forefront of the fight against cancer, harnessing the body’s own immune system in recognizing and selectively destroying the cancer cells while sparing normal ones. Immunotherapy, in addition to generally being more targeted and less toxic than commonly used types of chemotherapy, is also thought to be a strong type of approach aimed at preventing cancer recurrence.
BriaVax™, the Company’s lead product candidate, is a whole-cell breast cancer vaccine genetically engineered to release granulocyte macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system by allowing the body to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses.
The results of two previous Phase I clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with BriaVax™) have been encouraging in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to BriaVax™ with substantial reduction in tumor burden including lung and brain metastases. The company is currently conducting a Phase I/IIa clinical trial for BriaVax™ in patients with advanced breast cancer whose disease has progressed following at least one prior treatment course. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDx™, our companion diagnostic test. The interim data for the first 10 patients is expected by the first quarter of 2018.
For additional information on BriaCell, please visit our website: https://briacell.com
About the Phase I/IIa Clinical Trial
In a previous Phase I setting, a patient with metastatic breast cancer responded to BriaVax™ with objective reduction in tumor burden. To expand on this finding, after updating the clinical protocol of the original investigational new drug (IND) application, an open-label Phase I/IIa clinical trial enrolling up to 24 late-stage breast cancer patients with recurrent and/or metastatic disease has been launched. Patients will be administered BriaVax™ every two weeks for the first month of treatment, then monthly up to one year.
The primary objective of the Phase I/IIa clinical trial is to evaluate the safety of BriaVax™ in study subjects, and the principal secondary objective is an evaluation of the tumor size reduction. Tumor response will be monitored every three months during the study. The trial will also evaluate progression-free survival (PFS) and overall survival (OS).
For additional details regarding the clinical trial, please visit:
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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