Amunix Signs a Services and Supply Agreement With the University of Nebraska-Lincoln to Produce GMP-Grade XTEN® for Pharmaceutical Therapeutics
MOUNTAIN VIEW, CA–(Marketwired – Oct 27, 2014) – Amunix Operating Inc., a biotechnology company developing polypeptides which can be recombinantly fused or chemically conjugated to other peptides, proteins and small molecules, announced it has entered into a Services and Supply Agreement with the University of Nebraska-Lincoln Biological Process Development Facility to provide kilogram-scale, GMP-Grade XTEN for chemical conjugation. XTEN is Amunix’s proprietary protein-based polymer that mimics the biophysical properties of PEG and is used to extend the half-life of genetically fused therapeutic proteins and peptides.
“We are pleased to announce this agreement with the University of Nebraska-Lincoln. It enables us to offer a service to our partners and customers that provides a seamless supply of XTEN from preclinical quantities to the larger GMP-grade quantities necessary for use in clinical trials,” said Volker Schellenberger, PhD, Amunix President and CEO. “Amunix is now positioned to provide the enabling technology support for our partners and customers as they move candidate drugs through development towards commercialization.”
XTEN is a proprietary recombinant polypeptide that extends the in vivo half-life of therapeutics payloads. XTEN consists of naturally occurring hydrophilic amino acids and is biodegradable. Pharmaceuticals such as proteins, peptides and synthetic compounds can be XTENylated via chemical conjugation or genetic fusion. The XTEN platform technology is unique in that it offers better safety options than other half-life extension technologies for developing new therapeutics and minimizes immunogenicity risks due to its solubility and high hydrophilic properties.
Amunix has formed significant partnerships with Biogen Idec, Janssen Biotech, Inc., Versartis, Inc., and other leading organizations to develop products in a wide range of therapeutic areas. Amunix is actively seeking new partnerships to pursue additional therapeutic applications for its polymer.
Amunix Operating Inc., a biotechnology company headquartered in Mountain View, CA, has developed a novel half-life extension technology based on XTEN hydrophilic, unstructured polypeptides which can be recombinantly fused or chemically conjugated to other peptides, proteins and small molecules. Through this proprietary XTEN technology, the company creates and develops novel versions of clinically-proven pharmaceutical products that may offer better efficacy, safety, and dosing frequency by extension of the half-life. One XTEN product, exenatide-XTEN (VRS-859), has completed a Phase I study through Amunix partner Diartis. Amunix partner Versartis recently completed a Phase 2a clinical trial evaluating weekly, semi-monthly and monthly dosing regimens of hGH-XTEN (VRS-317) in children with growth hormone deficiency. In addition, through its partnership with Biogen Idec, Amunix is developing an XTENylated Factor VIII and is working with Janssen Biotech, Inc. and its affiliates to apply the XTEN half-life extension technology with protein and/or peptide therapeutics selected by Janssen. Amunix has several other undisclosed partners in various therapeutic areas. Founded in 2006, Amunix is a profitable, independent biotechnology company with no external investors. Amunix is actively seeking partnerships for application of its XTEN technology for half-life extension or tumor drug delivery. For additional information about the company, please visit www.amunix.com.
About the UNL-BPDF
The University of Nebraska-Lincoln Biological Process Development Facility (UNL-BPDF) uses a synergistic, multi-disciplinary approach to advance research-derived candidate vaccines and bio-therapeutics to Phase I/II clinical trials. BPDF fermentation processes are focused on optimizing and controlling high cell-density fermentations of Pichia pastoris, Saccharomyces cerevisiae, and Escherichia coli for production of recombinant proteins. For over 13 years, UNL-BPDF has provided customers with access to experienced biopharmaceutical process research & development scientists and engineers, state-of-the-art process development capabilities, and cGMP manufacturing facilities.
The UNL-BPDF is equipped with a recently commissioned, state-of-the-art cGMP facility with 6,000 ft2 of modular clean rooms and 7,000 ft2 of support space, including a pure steam generator, a water-for-injection (WFI) condenser, a 1000 gal WFI storage tank, and ambient and hot WFI distribution loops. The cGMP facility has 80 L and 200 L bioreactors and is able to accommodate a 1000 L bioreactor. The BPDF is equipped for downstream processing of both secreted and intracellular products derived from yeast or bacteria and is designed to produce Bulk Drug Substances. The BPDF also produces Master Cell Banks and Working Cell Banks. For additional information about the UNL-BPDF, please visit http://engineering.unl.edu/bpdf.