Södertälje, Sweden and Lund, Sweden, 3 April 2017: Cobra Biologics (Cobra), an international CDMO of biologics and pharmaceuticals, today announced that the immuno-oncology antibody ADC-1013 manufactured as part of the company’s cell line development programme for Alligator Bioscience AB (Alligator), a Swedish biotechnology company, has completed its first Phase 1 clinical trial.
As an essential step in the antibody production process, Cobra’s experienced and expert team developed the cell line expressing ADC-1013 for CD40 agonistic immuno-oncology using Cobra’s maxXpress service. The maxXpress platform harnesses the power of Ubiquitous Chromatin Opening Element (UCOE) technology and enables rapid and high-yielding production of correctly folded and glycosylated antibodies, 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 allowing rapid selection of the most suitable construct.
Having produced the cell line for ADC-1013, Cobra also analysed the Drug Substance (DS) and Drug Product (DP) for this particular trial, also performing DS and DP stability studies.
Peter Coleman, CEO Cobra Biologics, commented: “Congratulations to Alligator for their successful completion of their Phase I clinical trial with ADC-1013. For our cell line development team such announcements are extremely rewarding seeing their hard work contributing to the success of Alligator’s clinical trial.”
Dr Per Norlén, CEO, Alligator Bioscience, commented: “We are very happy to have completed the first clinical Phase I trial with ADC-1013. Alligator has a long-standing and successful collaboration with Cobra and has seen very good results using their maxXpress system for both ADC-1013 and other cell lines. ”
The Phase I trial was a dose-escalation study involving intratumoral and intravenous administration of ADC-1013 at five clinical sites in Sweden, Denmark and the UK (ClinicalTrials.gov: NCT02379741) including 24 patients and ten different tumour types.
Results are expected Q4 2017 and will focus on safety and tolerability, pharmacokinetics,
immunogenicity, biomarker response and clinical response evaluation.
In May 2015 Cobra released details of its involvement in manufacturing immuno-oncology
antibody ADC-1013, as part of Alligator’s Phase I trial in advanced solid tumours. Following
on from this success, in January 2016 Cobra was also contracted to develop a second cell
line ATOR-1015 for Alligator.