Laureate Biopharma has announced its successful collaboration with its client, ZZ Biotech, on process development and production of a new potential therapeutic for ischemic stroke.
The drug, known as 3K3A-APC, is a form of activated human Protein C whose molecular structure has been intentionally modified to remove the undesirable side effect of bleeding.
ZZ Biotech recently announced the start of Phase 1 trials with this material.
Protein C becomes an active protease upon enzymatic activation, a step that is carried out during the purification process. Once activated, this protease can degrade itself, since enzymes are also proteins.
Additional complexity arises from the production of isoforms as well as modified amino-acid structures that are important to the activity of 3K3A-APC.
Working together with scientists from ZZ Biotech and its collaborators, Laureate's scientists were relentless in overcoming these challenges to produce clinical-trial material.
Kent E. Pryor, Ph.D., Chief Operating Officer of ZZ Biotech said, "We are pleased to have been able to take a difficult protein out of the research lab and put it into the clinic. Our partnership with Laureate has been integral to turning an idea into a potential new human therapeutic."
"This project showcased Laureate's scientific expertise in developing suitable processes for clinical production of challenging proteins," noted Michiel E. Ultee, Ph.D., Laureate's Chief Scientific Officer.
Ultee continued, "We have successfully produced many fusion proteins, IgM antibodies, and other complex recombinant proteins for our clients to evaluate in the clinic."
Professor John H. Griffin, Ph.D., of The Scripps Research Institute and UCSD, and discoverer of 3K3A-APC, added, "During the development of the process for manufacturing 3K3A-APC, the Laureate process development team was invaluable in solving serious unforeseen impediments to the ultimate successful production of our product. It was a pleasure and a privilege to work hand-in-hand with this group of dedicated scientists."