BPDF Amunix Press Release

Amunix Establishes GMP Manufacturing of XTEN® at UNL BPDF

MOUNTAIN VIEW, CA–(Marketwired – Nov 16, 2015) – Amunix Operating Inc. (Amunix), a leader in the area of protein half-life extension, today announced that it has completed tech transfer and successful GMP (Good Manufacturing Practices) scale-up of Amunix’s XTEN® manufacturing process at the University of Nebraska-Lincoln Biological Process Development Facility (UNL-BPDF). XTEN is the brand name for Amunix’s protein-based, patented half-life extension technology. Process scale-up at UNL-BPDF was successfully completed in the second quarter of this year, enabling kilogram production of GMP grade XTEN using the highly efficient, fermentation-based XTEN processing platform developed at Amunix.

“The enablement of our platform XTEN process technology at GMP scale is a significant milestone for Amunix as we now have the ability to flexibly and efficiently engage in the cGMP production of internal and external pipeline products slated for clinical evaluation,” said Ulrich Ernst, Ph.D., SVP, technical operations at Amunix. “We commend the staff at The Biological Process Development Facility at UNL for working seamlessly with Amunix to ensure technical success and achieve this important advancement.”

Volker Schellenberger, Ph.D., president and CEO of Amunix, added, “The availability of scalable cGMP XTEN manufacturing provides Amunix and our development partners with another versatile tool to explore and evaluate clinically novel candidates that have been enhanced with Amunix’s patented XTEN half-life extension technology. It also sets the stage for accelerating our internal and external partnering development efforts.”

Wallace Buchholz, Ph.D., director of UNL-BPDF, said, “The collaboration with Amunix for the development and production of various XTEN and XTENylated products embodies our commitment to advancing novel therapeutics that address current healthcare challenges. We are looking forward to providing continuing support for Amunix-partnered programs and to leverage our experience and expertise in fermentation technology, scale-up, and clinical manufacturing.”