Challenges from Complex Protein Overcome
PRINCETON, N.J., Aug. 13, 2012 /PRNewswire/ -- Laureate Biopharma is pleased to announce 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. "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."
About Laureate Biopharmaceutical Services, Inc.
Laureate Biopharmaceutical Services, Inc. is a full-service biopharmaceutical contract development and manufacturing organization. Laureate Biopharma's scientists are expert in process development and cGMP production of therapeutic proteins, including monoclonal antibodies and Fc-fusion proteins. In addition, the company's portfolio of services includes aseptic filling, cell line development, analytical and stability testing, and regulatory support. Laureate Biopharma has served a global client base from its Princeton, New Jersey facility since 1981 and is a portfolio company of Saints Capital, LLC. For more information, please visit www.LBioS.com.
About Saints Capital, LLC
Saints Capital is a leading direct secondary acquirer of venture capital and private equity investments in emerging growth companies around the globe. It also makes traditional direct venture capital investments on a primary basis and in special situations in technology, healthcare, consumer and industrial companies in the United States. Founded in 2000, Saints provides liquidity for private investors in such markets as investment and commercial banks, buyouts, corporate venture capital and hedge funds. Saints has more than $1 billion of committed capital under management, over 50 completed portfolio transactions and investments in more than 200 companies. For more information, please visit www.saintsvc.com.
About ZZ Biotech, LLC
ZZ Biotech is headquartered in Houston, TX with a mission to develop innovative biological treatments for the aging and damaged brain, including those affected by stroke and other neurodegenerative disorders. ZZ Biotech is developing a genetically engineered variant of recombinant human wild-type activated Protein C (APC), named 3K3A-APC, that has reduced anticoagulant activity, but preserved cell-protective and anti-inflammatory activities compared to APC. ZZ Biotech is studying the safety and pharmacokinetics of 3K3A-APC in healthy human volunteers in an ongoing Phase 1 clinical study. For more information, please visit www.zzbiotech.com.
SOURCE Laureate Biopharma