Cobra Biologics and BioCancell have entered an agreement for the manufacture of BioCancell’s BC-821 cancer drug for clinical trials. The Phase I trial, scheduled to begin in 2015, will examine the use of BC-821 as a treatment for several cancer indications such as non-small-cell lung carcinoma, ovarian cancer, glioblastoma and liver metastasis.
Cobra will provide GMP manufacture and aseptic fill/finish of BC-821 plasmid DNA, before releasing it for clinical trials. Cobra’s DNA programs offer full regulatory support from a dedicated Quality Assurance (QA) team.
Peter Coleman, chief executive officer of Cobra Biologics, said, “Cobra has been manufacturing plasmid therapeutics and DNA vaccines for more than 16 years and I am delighted that we are able to announce this partnership with BioCancell. Our DNA platform process is based on Cobra’s pioneering heritage in gene therapy manufacturing and technology development.”