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Lonza and Renova Therapeutics Announce Manufacturing Agreement for Clinical Supply of RT-100 Gene Therapy

Lonza Group Ltd

Lonza and Renova Therapeutics Announce Manufacturing Agreement for Clinical Supply of RT-100 Gene Therapy

12 Feb 2016
Alex Waite
Editorial Assistant

Industry news

Lonza Houston, Inc., a global leader in viral gene therapy manufacturing, and Renova™ Therapeutics, a biopharmaceutical company developing gene therapy treatments for congestive heart failure and other chronic diseases, have entered into a Manufacturing Services Agreement to develop a scalable manufacturing process and produce cGMP-grade RT-100 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, 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.

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