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.
Lonza’s Pharma&Biotech segment head of emerging technologies business unit Andreas Weiler said: "This agreement with Renova continues to demonstrate Lonza’s leadership position in viral vector production.
"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."
Renova Therapeutics CEO and Co-founder Jack Reich said: "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.
"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.