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Alligator completes Phase I trial


Biotech company Alligator Biosciences has finished its first Phase I clinical trial with the immuno-oncology antibody ADC-1013.

CDMO Cobra Biologics has manufactured the antibody as part of the company’s cell line development programme for Alligator. Cobra has developed the cell line expressing ADC-1013 for CD40 agonistic immuno-oncology using their maxXpress service, which harnesses the power of ubiquitous chromatin opening element technology. 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.Cobra also analysed the Drug Substance (DS) and Drug Product  (DP) for this particular trial, also performing DS and DP stability studies.

“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,” said Dr Per Norlén, CEo of Alligator Bioscience.

Results are expected Q4 2017

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 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.