04.03.17
Cobra Biologics’ immuno-oncology antibody ADC-1013 manufactured as part of the company’s cell line development program for Alligator Bioscience, has completed its first Phase I trial.
As an essential step in the antibody production process, Cobra’s team developed the cell line expressing ADC-1013 for CD40 agonistic immuno-oncology using its maxXpress service platform to enable rapid and high-yielding production of correctly folded and glycosylated antibodies, complimented its cell based potency assays and high resolution mass spectrometry analytical services. The maxXpress service can assess as many as nine constructs at a time and can generate purified mixed clonal pool material in 10 weeks, allowing rapid selection of the most suitable construct.
Cobra also analyzed the Drug Substance (DS) and Drug Product (DP) for this particular trial, performing stability studies.
Peter Coleman, chief executive officer of Cobra Biologics, said, “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, chief executive officer of Alligator Bioscience, said, “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 sites in Sweden, Denmark and the UK, including 24 patients and ten different tumor types.
As an essential step in the antibody production process, Cobra’s team developed the cell line expressing ADC-1013 for CD40 agonistic immuno-oncology using its maxXpress service platform to enable rapid and high-yielding production of correctly folded and glycosylated antibodies, complimented its cell based potency assays and high resolution mass spectrometry analytical services. The maxXpress service can assess as many as nine constructs at a time and can generate purified mixed clonal pool material in 10 weeks, allowing rapid selection of the most suitable construct.
Cobra also analyzed the Drug Substance (DS) and Drug Product (DP) for this particular trial, performing stability studies.
Peter Coleman, chief executive officer of Cobra Biologics, said, “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, chief executive officer of Alligator Bioscience, said, “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 sites in Sweden, Denmark and the UK, including 24 patients and ten different tumor types.