The CDMO announced the drug development partnership extension followings its success developing a cell line for the mAb, ADC-1-13.
Specifically, Alligator has requested additional support from Cobra to develop the cell line for production of a new drug candidate ADC-1015 – a bispecific immune activator.
Cobra initially announced its involvement in manufacturing immuno-oncology antibody ADC-1013 as part of Alligator’s Phase I trial in advanced solid tumors in May 2015.
The study assessed the safety, pharmacokinetics, and pharmacodynamics of ADC-1013 in up to 40 patients across sites in the UK, Sweden, and Denmark.
As Biopharma-Reporter.com reported at the time, the partnership was significant as it showed regulators accepted UCOE-based cell line engineering.
UCOE (Ubiquitous Chromatin Opening Element) vectors are used in the company’s MaxXpress platform to insert genes into DNA cells.
Cobra will use this expression system in addition to a historically documented master cell bank (CHO-S) and chemically defined media moving forward. According to the company, the combination delivers times savings in cell line development and a clone selection process suitable for GMP manufacture.