KBI Biopharma and BriaCell Therapeutics Corp. Enter Cell Therapy Manufacturing Agreement for BriaVaxTM Cancer Vaccine
RESEARCH TRIANGLE PARK, NC and BERKELEY, CA/ March 24, 2017 – KBI Biopharma, Inc. (KBI), an award-winning global biopharmaceutical contract development and manufacturing organization, and BriaCell Therapeutics Corp. (BriaCell) (TSXV: BCT) (OTCQB: BCTXF), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, have entered into a cell therapy development and manufacturing agreement for BriaCell’s BriaVaxTM, an allogeneic, genetically engineered whole-cell vaccine derived from a human breast cancer cell line.
Leveraging the extensive experience, technical expertise, and high-tech facilities of KBI’s Cell Therapy Group, BriaCell has partnered with KBI to provide clinical supplies of product candidate for a Phase I/IIa clinical trial of BriaVaxTM in patients with advanced breast cancer. Earlier this month, BriaCell received FDA clearance to initiate its Phase I/IIa trial.
“We are very excited to partner with BriaCell to advance their unique technology. KBI’s cell therapy experts – who have been developing therapies under IND since 2001 – will work alongside BriaCell’s exceptional team to accelerate the delivery of this promising targeted immunotherapy to late-stage breast cancer patients who currently have very limited therapeutic options,” said Tim Kelly, President of KBI.
To date, BriaVaxTM has shown impressive safety and efficacy results in a small number of patients, including better than expected survival and widespread tumor regression, without serious side effects. In addition to BriaVaxTM, BriaCell also plans to expand its pipeline of oncology vaccine candidates with its proprietary technology platform.
KBI’s Houston area cell therapy operation has built the expertise and capabilities to respond to a rapidly expanding cell therapy market. KBI has ISO 7 cGMP manufacturing suites, sophisticated logistics/warehousing operations, and extensive flow cytometry and analytical infrastructure.
About KBI Biopharma
KBI Biopharma is a biopharmaceutical contract development and manufacturing organization that accelerates the development of innovative discoveries into life-changing biological products. From early-stage biotech and academic/non-profit organizations to many of the world’s largest pharmaceutical companies, KBI has served 250+ clients globally to accelerate and optimize their drug development programs.
KBI’s extensive track record of successful programs is a result of its unique approach: applying the insight gained from our advanced biophysical and analytical protein characterization techniques to the development of robust and scalable processes. KBI delivers accelerated and integrated process development and cGMP manufacturing programs for a wide range of recombinant protein Active Pharmaceutical Ingredients (API) and cell therapy products for our clients.
KBI was founded in 1996 and operates 4 facilities: Durham and Research Triangle Park (NC), Boulder (CO), and The Woodlands (TX).
BriaCell is an immuno-oncology focused biotechnology company developing a more targeted, less toxic approach to cancer management. 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.
BriaVaxTM, 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 BriaVaxTM 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 BriaVaxTM) have been encouraging in patients with advanced solid tumors. Most notably, one patient with metastatic breast cancer responded to BriaVaxTM with substantial reduction in tumor burden including lung and brain metastases.
For additional information on BriaCell, please visit the Company’s website: www.briacell.com
KBI Biopharma, Inc.