Pfizer to Manufacture Vivet Therapeutics Investigational Gene Therapy for Wilson Disease
Pfizer Inc. and Vivet Therapeutics have entered into a manufacturing agreement under which Pfizer will produce Vivet's investigational gene therapy, VTX-801, for the potential treatment of Wilson disease. Clinical trials are expected to begin in early 2021.
New York, NY – September 23, 2020 – Pharmaceutical giant Pfizer Inc. and French biotechnology company Vivet Therapeutics have signed a manufacturing agreement. Under the terms, Pfizer will produce Vivet's experimental gene therapy, VTX-801, for an upcoming Phase 1/2 clinical trial evaluating its potential to treat Wilson disease. The trial is slated to commence in early 2021. Financial details of the agreement were not disclosed.
VTX-801 is an investigational gene therapy targeting Wilson disease, a rare and potentially life-threatening genetic disorder characterized by copper accumulation in the liver and other organs. This manufacturing agreement builds on a prior collaboration announced in March 2019, which included Pfizer acquiring a minority equity interest in Vivet and securing an option for full acquisition.
The clinical supply of VTX-801 will be manufactured at Pfizer's facility located in Chapel Hill, North Carolina. The company has recently made significant investments in its gene therapy manufacturing capabilities at this site, aiming to bolster its capacity for producing both clinical and commercial quantities of gene therapies.
Vivet Therapeutics CEO Jean-Philippe Combal described the manufacturing of gene therapies as a complex undertaking and expressed optimism that the agreement would strengthen the partnership with Pfizer and support the long-term development of VTX-801. Seng Cheng, Chief Scientific Officer for Pfizer's Rare Disease Research Unit, acknowledged the progress in Pfizer's gene therapy manufacturing and the strategic importance of supporting emerging therapies for patients with rare diseases.