We've updated our Privacy Policy to make it clearer how we use your personal data.

We use cookies to provide you with a better experience. You can read our Cookie Policy here.


Lonza and Renova Therapeutics Announce Manufacturing Agreement for Clinical Supply

Want a FREE PDF version of this news story?

Complete the form below and we will email you a PDF version of "Lonza and Renova Therapeutics Announce Manufacturing Agreement for Clinical Supply"

Listen with
Register for free to listen to this article
Thank you. Listen to this article using the player above.
Read time:

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.