Lonza signs manufacturing agreement with Renova Therapeutics for clinical supply of gene therapy treatment

Lonza will develop a cost-effective, scalable and robust suspension culture-based adenovirus manufacturing platform

Lonza Houston, a specialist in viral gene therapy manufacturing, has agreed to develop a scalable manufacturing process and produce cGMP-grade drug product for Renova Therapeutics' future clinical trials.

Renova Therapeutics, located in San Diego, CA in the US, is a biopharmaceutical company developing gene therapy treatments for congestive heart failure and other chronic diseases.

Lonza says it will develop 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 Renova's RT-100 gene therapy.

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 II 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.

'This agreement with Renova continues to demonstrate Lonza’s leadership position in viral vector production,' said Andreas Weiler, Head of the Emerging Technologies Business Unit for Lonza’s Pharma&Biotech segment.

'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,' added Jack Reich, 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.'

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