Lonza and Renova Therapeutics Announce Manufacturing Agreement for Clinical Supply
News Feb 23, 2016
Lonza Houston, Inc and Renova™ Therapeutics have entered into a Manufacturing Services Agreement to develop a scalable manufacturing process and produce cGMP-grade RT-100 (Ad5.hAC6) Drug Product for use in Renova’s future clinical trials.
This relationship will leverage Lonza’s expertise for the development of a cost-effective, scalable and robust suspension culture-based adenovirus manufacturing platform, which is anticipated to enable the production of sufficient material to meet the potential demand for promising gene therapies such as RT-100.
“This agreement with Renova continues to demonstrate Lonza’s leadership position in viral vector production,” said Andreas Weiler, Ph.D., Head of Emerging Technologies Business Unit for Lonza’s Pharma&Biotech segment. “Lonza will utilize our cGMP manufacturing knowledge and world-class quality systems to help Renova develop these promising novel therapeutics for patients as RT-100 is moving toward late-phase clinical trials.”
“Lonza’s extensive knowledge in viral manufacturing makes them a great partner in our development of further clinical supply of RT-100 for the treatment of congestive heart failure,” said Jack W. Reich, Ph.D., CEO and Co-founder of Renova Therapeutics.
“This is one of several exciting milestones for Renova [Therapeutics], as we continue our research and development efforts for cardiovascular and metabolic diseases that affect millions of patients worldwide.”
RT-100 is an investigational product that uses a non-replicable viral vector – adenovirus 5 – to deliver a therapeutic gene encoding the protein AC6 (adenylyl cyclase type 6) directly to the heart tissue during a routine outpatient procedure without the need for surgery.
A Phase 2 trial for RT-100 in patients with congestive heart failure has been completed. Lonza will manufacture the clinical supplies needed for Renova Therapeutics to conduct pivotal trials of RT-100.
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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