Cobra Biologics, an international CDMO of biologics and pharmaceuticals, has developed a cell line for Alligator Bioscience, a Swedish biotechnology company, expressing monoclonal antibodies for a Phase 1 clinical trial which commenced in April 2015.
Development of the cell line expressing the antibodies for CD40 Agonistic Immuno-Oncology ADC-1013 was performed by Cobra using the maxXpress platform which harnesses the power of Ubiquitous Chromatin Opening Element (UCOE) technology. Combined with Cobra’s experienced and expert cell line development team, and the added benefit of the Ambr robotic system, the platform enables rapid and high-yielding production of correctly folded and glycosylated recombinant proteins, complimented by Cobra’s in-house cell based potency assays and high resolution mass spectrometry analytical capability. The maxXpress service can assess up to nine constructs at a time and can generate purified mixed clonal pool material in just 10 weeks.
The study, led by Alligator Bioscience, will determine the safety, pharmacokinetics and pharmacodynamics of intratumourally administered ADC-1013, enrolling up to 40 patients during the dose escalation and expansion phases at five centres in the United Kingdom, Denmark and Sweden.
Peter Coleman, CEO Cobra Biologics, commented: “I am delighted that we have had the opportunity to work with Alligator on this promising clinical programme and would like to congratulate the team on their success to date. Cobra has been manufacturing protein therapeutics since 1995 and our maximum protein expression platform, maxXpress, has proven to be very popular to customers looking for both speed and quality.”
Dr Per Norlén, CMO & VP Development Alligator Bioscience, commented: “ADC-1013 has been found to have good developability properties; manufacturing resulted in a very pure and stable Drug Product that has now been successfully administered to patients.”