Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today that its Chemistry, Manufacturing, and Controls (CMC) Specialty Group advised BriaCell Therapeutics Corp. (TSXV: BCT) (OCTCQB: BCTXF), a clinical-stage company dedicated to the development of immuno-oncology treatments, in the preparation and filing of a CMC amendment detailing the extensive testing performed on BriaVax™, the company’s proprietary vaccine for advanced breast cancer. Following its review of the amendment, the FDA granted BriaCell authorization to initiate its Phase I/IIa clinical trial.
Biologics Consulting’s CMC Specialty Group provides regulatory, quality assurance and compliance consulting services for pharmaceutical and biologic products. The group brings decades of FDA and industry experience in the areas of quality-based manufacturing and analytical method development, validation and troubleshooting, formulation development, and stability strategy and evaluation. The CMC team also assists clients with the preparation and review of regulatory submissions, risk-based strategies for product development, PAI readiness, oversight of contract services, and the design, implementation and upgrade of cGMP systems for a wide range of products.
Biologics Consulting played an integral role in the compilation and submittal of BriaCell’s extensive CMC amendment, ultimately leading to FDA authorization to initiate the Phase I/IIa clinical trial. The amendment contained a detailed analysis of comprehensive testing on a new batch of BriaVax™ (to be used for the upcoming clinical study) and BriaTest™ (the parental cell line, SV-BR-1, used to evaluate hypersensitivity to BriaVax™).
“Biologics Consulting has a world-class team of regulatory consultants with years of industry and FDA insight that enable them to expertly guide our clients through each phase of the FDA process. We are thrilled to have played an integral role in helping the BriaVax™ treatment achieve another significant milestone in the challenging FDA approval process,” commented Norman Baylor, CEO of Biologics Consulting. “Biologics Consulting believes that innovative and need-based medical products like BriaVax™ have the potential of providing a better future for everyone, and we are proud to be part of the talented team working diligently to make this product available to patients.”
“Biologics Consulting, along with our colleagues at UC Davis GMP Facility, did a tremendous job putting this submission together” commented Dr. Bill Williams, BriaCell’s President and CEO. “Thanks to their hard work and expertise, we have reached a key milestone in the development of BriaVax™. FDA’s favorable review of this submission has cleared the path to initiate the Phase I/IIa clinical trial of BriaVax™ and its companion diagnostic platform, BriaDx™, to bring hope to patients with advanced breast cancer.”
BriaVax™ is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. It is believed to activate the immune system to recognize and eliminate cancerous cells by potentially inducing tumor directed T cell and antibody responses. BriaCell is on track to launch its open-label Phase I/IIa clinical trial to evaluate the safety and activity of BriaVax™ in patients with metastatic breast cancer in 2017.
About Biologics Consulting (www.biologicsconsulting.com)
Biologics Consulting Group, Inc. is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. Founded in 1993, Biologics Consulting has built a record of achievement, assisting clients worldwide with nonclinical and clinical, product development and regulatory compliance challenges.
Biologics Consulting has served more than 3,500 companies in 53 countries, and in the past four years, it has contributed to more than 50 original INDs, 75 BLAs/NDAs (full and supported), 80 510Ks, and 42 IDEs.
About BriaCell Therapeutics Corp. (www.briacell.com)
BriaCell is an immuno-oncology biotechnology company developing a more targeted and potentially less toxic approach to cancer management compared to traditional chemotherapy strategies. BriaCell’s mission is to serve late-stage cancer patients with limited treatment options.
Immunotherapy has come to the forefront of the fight against cancer, harnessing the body’s own immune system to recognize and selectively destroy cancer cells while sparing normal cells. Immunotherapy, in addition to generally being more targeted than commonly used types of chemotherapy, is also thought to be a highly potent approach aimed at preventing cancer recurrence.
BriaVax™, the Company’s lead product candidate, is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. It is believed to activate the immune system to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses. The Company has already demonstrated encouraging clinical results, and is intent on building upon these results to further advance BriaVax™ through additional FDA-approved clinical trials in order to help cancer patients with limited therapeutic options. 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 solid tumors. Most notably, one patient with metastatic breast cancer responded to BriaVax™ with substantial reduction in tumor burden including lung and brain metastases.