Lonza and Renova Therapeutics Announce Manufacturing Agreement for Clinical Supply of RT-100 Gene Therapy
Basel (CH) and San Diego, CA (USA), 10 February 2016 – 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 (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.