Bioverativ announces FDA acceptance of Investigational New Drug Application for BIVV001 a novel, long-acting FVIII hemophilia therapeutic utilizing Amunix XTEN® half-life extension technology
MOUNTAIN VIEW, CA--(GlobeNewswire – June 14, 2017) – Amunix Operating Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has accepted Bioverativ’s (NASDAQ: BIVV) Investigational New Drug (IND) application for BIVV001 (also known as rFVIII Fc-VWF-XTEN) a novel, investigational Factor VIII therapy designed to potentially extend protection from bleeding episodes via prophylactic once-weekly dosing or longer for patients with hemophilia A.
BIVV001 is the only investigational Factor VIII therapy in development that has been designed to overcome the von Willebrand factor ceiling, which is believed to impose a half-life limitation on current Factor VIII therapies.
“We are very pleased by the announcement from Bioverativ that clinical enrollment is planned to begin in the latter half of 2017. This represents the second clinical trial involving an XTEN-based product to be initiated this year”, remarked Volker Schellenberger, CEO and President of Amunix. “We look forward to the evaluation of BIVV001 in the clinic and the continued progression of Bioverativ’s hemophilia programs that exploit the advantages offered by the XTEN technology platform.”
Amunix, based in Mountain View, CA, is a privately held biotechnology company focused on the discovery and development of biologics with improved in vivo half-lives. Amunix’ half-life extension technology is based on XTEN — hydrophilic, unstructured, biodegradable proteins that impart a number of favorable properties upon the molecules to which they are attached. XTEN can be recombinantly fused or chemically conjugated to peptides, proteins, and other pharmaceuticals. In addition to the advantages of reduced dosing frequency, XTENylation also stabilizes plasma drug concentrations, which often results in increased efficacy as well as reduced side effects. Two genetically fused XTENylated products have been tested clinically. VRS-859 (exenatide-XTEN) has been tested through Phase I in the treatment of diabetes and VRS-317 (human growth hormone-XTEN) is currently in Phase III testing. Amunix is also working with additional partners, including Eli Lilly, Bioverativ, Roche, Janssen, Genentech, Naia and other undisclosed companies in a wide range of therapeutic areas.
Amunix is developing an internal pipeline of ProTIA (Protease Triggered Immune Activator) immuno-oncology therapeutics. ProTIAs are bispecific molecules that bind tumor antigens and T cells. ProTIAs are administered as long-acting prodrugs that can be activated in the tumor environment by tumor-associated proteases. Amunix is actively seeking partnerships for applications of its XTEN technology and its ProTIA platform. For additional information about the company, please visit www.amunix.com.
Volker Schellenberger, Ph.D.
President and CEO