Saturday, September 26, 2020
Vivet Therapeutics, a privately held gene therapy biotechnology company dedicated to developing treatments for severe inherited liver diseases, and Pfizer Inc. announced that have signed a manufacturing agreement, under which Pfizer will supply the necessary material for a phase 1/2 clinical trial that will evaluate the safety and efficacy of VTX-801, Vivet's proprietary investigational gene therapy vector, for the treatment of Wilson's disease, a rare and life-threatening liver disorder. Phase 1/2 of the clinical trial is expected to begin in early 2021. Terms of the agreement have not been disclosed.
In March 2019, the companies announced that Pfizer had acquired a minority stake in Vivet and secured an exclusive option to acquire all of Vivet's outstanding shares. The companies also announced that they would collaborate in the development of VTX-801, for which it is planned to submit an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA). in English) in 2020.
"Manufacturing potentially transformative gene therapy technologies is a very complex undertaking and we look forward to this milestone further strengthening our relationship with Pfizer and ensuring the long-term development of VTX-801," said Jean-Philippe Combal, Co-Founder and CEO of Vivet Therapeutics.
The VTX-801 clinical supply for Phase 1/2 will be manufactured at the Pfizer facility in Chapel Hill, North Carolina, USA. In recent years, Pfizer has made significant investments in the company's gene therapy product manufacturing facility in North Carolina to strengthen its ability to produce large quantities of gene therapy products on a clinical and commercial scale for patients with disease. rare all over the world.
"We are proud of the significant progress made by our company in our ability to manufacture gene therapy products. This milestone is key to our relationship with Vivet and underscores the importance of our strategic investments in research and supply of gene therapy products, to support the timely delivery of these innovative therapies to patients, "says Seng Cheng, chief scientist in Pfizer's rare disease research division.
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