European patent granted for XL-protein’s PASylation® technology

FREISING, GERMANY, MARCH 17th, 2011 – XL-protein GmbH, a German biotech company that specialises in the development of biopharmaceuticals with extended plasma half-life, today announced that the European Patent Office granted a core patent (EP2173890) for XL-protein’s PASylation® technology.

Beside the granted PASylation® EP patent, several other corresponding national patent applications are currently processed worldwide. The European patent covers the use of random coil polypeptide sequences comprising the natural amino acids Proline, Serine, and Alanine (PAS) to enhance the stability of biologically active proteins if attached as part of a fusion protein.

The N- or C-terminal PAS tag can be directly produced together with the therapeutic protein in microbial hosts, e.g. E. coli, or in cell culture, thus avoiding costly in vitro coupling steps that are required for other presently available approaches such as PEGylation. Furthermore, the biodegradability of the PAS polypeptide should prevent organ accumulation during chronic treatment.

PASylation® can be applied both to existing biologics, yielding ‘biobetters’, or to innovative therapeutic proteins or peptides, leading to a 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, eventually allowing less frequent and lower dosing together with better tolerability for patients.

Dr. Arne Skerra, founder and CEO of XL-protein GmbH, said: “This patent is an important milestone for our company and its collaboration partners. It reinforces our competitive market position and will strengthen corporate development”.
This revolutionary principle for increasing drug stability was originally developed at the Technische Universität München (TUM). In 2009, XL-protein entered into a license agreement with TUM via Bayerische Patentallianz GmbH, the central patent and marketing agency for 28 Bavarian universities and universities of applied sciences, and acquired the exclusive worldwide rights for the PASylation® technology, which also includes the right to grant sublicenses.
Mr. Peer Biskup, CEO of the Bayerische Patentallianz GmbH, commented: “The Bayerische Patentallianz is very pleased with the timely decision of the EPO to grant the first PASylation® patent and with the positive development of XL-protein’s business, which involves both in house drug development activities and partnering with pharma and biotech companies.”