CRO Cancer Insight will manage BriaCell’s upcoming Phase I/II breast cancer trial program as the Californian biotech looks to provide proof of concept for its cancer vaccine.
Under the terms of the deal, financial details of which have not been disclosed, BriaCell will sponsor the clinical trial of BriaVax in advanced breast cancer, while Cancer Insight will provide clinical and regulatory affairs management services for the entire trial.
The team at Cancer Insight is led by Dr. George Peoples, a surgical oncologist, and an expert in breast cancer vaccines and immunotherapy currently overseeing clinical trials at over 32 clinics.
“Appointing Cancer Insight to support us in further clinical advancement of BriaVax is a major milestone for BriaCell,” said Dr. Charles Wiseman, founder and director of BriaCell.
“We have been carefully selecting our partners to be those with extensive experience in manufacturing, regulatory, and clinical development aspects of our cancer vaccine.”
Cancer Insight's founder, Dr. George Peoples, added: “Cancer Insight is extremely pleased that BriaCell has chosen us as a partner to manage this innovative Phase I/IIa program for BriaVax in advanced breast cancer. Our company is highly experienced in the breast cancer vaccine space, and is a leader in conducting biomarker and imaging analysis studies for the clinical advancement of cancer vaccine candidates.
“Using our unique platform, BriaVax will be tested for its anti-tumor effects at multiple sites, in addition to breast tumors--its primary focus--as authorized by the FDA in the Phase I/IIa program.”
The vaccine, BriaVax, is a whole-cell breast cancer vaccine genetically engineered to release GM-CSF, a natural substance the body amplifies to activate the immune system. A number of biotechs are using this approach with a common theme of immunotherapy now becoming the norm in cancer research.
Previously, a small Phase I study showed near complete regression of metastatic breast cancer deposits in the breast, lung, soft tissue and even the brain, according to BriaCell.
The new Phase I/IIa study will evaluate BriaVax in up to 24 advanced breast cancer patients. The dosing of patients is scheduled to begin this summer which will be followed by co-development of BriaDx, a companion diagnostic test.
Many experimental cancer vaccines have however suffered from either safety or efficacy issues over the years--and it remains a difficult therapy to develop and market successfully.
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