XL-protein announces preclinical in vitro and in vivo data for its PASylated human growth hormone (hGH) program, xl020

FREISING, GERMANY, September 23, 2011 – XL-protein GmbH, a German biotech company specialised in the development of biopharmaceuticals with extended plasma half-life, announced today preclinical in vitro and in vivo data for its xl020 PAS-hGH program. The xl020 data demonstrate XL-protein's ability to furnish an approved biological drug with improved in vivo stability and plasma half-life using its proprietary PASylation® technology, leading to enhanced efficacy in an established animal model.

The results of XL-protein's xl020 studies will be presented at the R&D of Novel Protein Therapeutics and Post-Translational Modifications Conferences on Tuesday and Wednesday 27/28 September 2011 in Berlin, Germany, in a presentation entitled "PASylation: a biological alternative to PEG for extending the plasma half-life of biopharmaceuticals".

"This program is extremely exciting because it provides an in vivo proof of concept that a PASylated biological does not only show prolonged pharmacokinetics but also increased potency, even if applied at longer time intervals compared with the unmodified protein," stated Uli Binder, co-founder and CTO of XL-protein GmbH.

XL-protein researchers documented that xl020 has much longer plasma-half life than the unmodified recombinant growth hormone while retaining high receptor binding activity, which translated into increased in vivo efficacy. In a preclinical mouse model of growth hormone deficieny, xl020 administration showed continuous strong weight gain over at least 10 days.

Arne Skerra, co-founder and CEO of XL-protein GmbH, said: "Our PASylated hGH program highlights XL-protein's strategy of developing superior therapeutics based on approved biopharmaceuticals. xl020 is a promising development candidate that addresses a multi-billion dollar market world-wide."

hGH is a natural peptide hormone that regulates body growth and metabolism. Growth hormone deficiency (GHD) can occur in both pediatric and adult patients (GHDA). Furthermore, hGH is currently approved for several other indications, for example AIDS wasting and cachexia or short stature caused by Turner's Syndrome or Prader-Willi syndrome. xl020 should allow less frequent and lower dosing, promising better tolerability and patient compliance, also benefiting from the inherent biodegradability of PAS polypeptides.

XL-protein's proprietary PASylation® technology can be applied both to existing biologics, yielding 'biobetters', or to innovative therapeutic proteins or peptides, leading to tunable prolonged plasma half-life by a factor 10-100 as demonstrated in numerous animal studies. Thus, PASylation® offers a superior solution to a general problem in biological drug development.

About XL-protein GmbH
XL-protein GmbH is a privately owned biopharmaceutical company based in Freising-Weihenstephan, Germany, that exploits the PASylation® technology to develop second generation biopharmaceuticals with extended plasma half-life. XL-protein was founded in 2009 as a spin-off from the Institute of Biological Chemistry at the Technical University of Munich (TUM). With its strong proprietary technology position, XL-protein focuses at the preclinical as well as clinical development of PASylated protein and peptide drugs in commercially attractive disease areas. Discovery programs at XL-protein are supported by the German Federal Ministry of Education and Research, the munich biotech cluster m4, and the Innovation and Startup Center for Biotechnology (IZB) in Freising-Weihenstephan. XL-protein is engaged in a collaboration with Phylogica Ltd (ASX: PYC), a leading Australian-based drug discovery company, and in various undisclosed partnerships with the Pharma and Biotech industry.

About PASylation®
PASylation® is the genetic fusion of a therapeutic protein with a conformationally disordered polypeptide of defined sequence comprising the amino acids Pro, Ala, and Ser. This technology provides a superior way to attach a solvated molecular random chain with large hydrodynamic volume to a biologically active protein. as a result of this size effect, the typically rapid clearance via kidney filtration of a biopharmaceutical can be retarded by a factor 10-100, depending on the length of the PAS sequence. PAS sequences are highly soluble though uncharged, retain the biological activity of the fusion partner, offer efficient recombinant protein production and/or secretion in E. coli as well as eukaryotic host cells, avoid chemical coupling procedures, are non-toxic, non-immunogenic, biochemically inert and stable against plasma proteases, while being biodegradable.

XL-protein GmbH
Lise-Meitner-Str. 30
85354 Freising
Germany

Contact information:
Dr. Arne Skerra
Managing Director
Phone: 08161/53730-90
eMail: skerra@xl-protein.com

Web: http://www.xl-protein.com

This release was published on openPR.