Lonza and Renova Therapeutics Announce Manufacturing Agreement for Clinical Supply of RT-100 Gene Therapy
February 10, 2016
Basel (CH) and San Diego, CA (USA) – 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.
Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life. Not only are we a custom manufacturer and developer, Lonza also offers services and products ranging from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from the vitamin B compounds and organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens. Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 40 major manufacturing and R&D facilities and approximately 9,800 full-time employees worldwide. The company generated sales of about CHF 3.8 billion in 2015 and is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients. Further information can be found at www.lonza.com.
About Renova Therapeutics
Renova™ Therapeutics is developing definitive, one-time gene therapy treatments to restore the health of people suffering from chronic diseases. The first two indications the company is pursuing are therapies for congestive heart failure (CHF) and type 2 diabetes, two of the most common and devastating chronic diseases in the world. The company’s lead investigational product, RT-100, is a new type of treatment that delivers a therapeutic gene directly to damaged heart tissue during a routine outpatient procedure and has the potential to renew heart function in millions of patients with CHF. The company’s product pipeline also includes a second-generation therapy for CHF patients and a groundbreaking therapy in preclinical stage for sufferers of type 2 diabetes. Renova Therapeutics was founded in 2009 and is led by an experienced management team in biopharmaceuticals and gene therapy. For additional information about the company, please visit www.renovatherapeutics.com.