CEVEC’s CAP®Go derived recombinant placental human alkaline phosphatase shows superior results in a preclinical study

  • New CAP®Go cell line for the production of glyco-optimized recombinant human alkaline phosphatase successfully established
  • CAP®Go derived recombinant human alkaline phosphatase optimized to address therapeutic needs in chronic inflammatory indications and neurodegenerative diseases

Cologne, Germany, July 06, 2015

CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins, today announced the results of a preclinical animal study in which its CAP®Go derived recombinant placental human alkaline phosphatase (PLAP) showed significantly prolonged serum-half-life.

The Company’s glyco-optimized PLAP displayed a four times longer serum half-life in a pivotal rat study in comparison to an earlier recombinant version of the molecule. The new PLAP molecule originates from a newly developed cell line of CEVEC’s recently introduced CAP®GO technology, which provides for specifically improved glycosylation patterns.

Today, various alkaline phosphatase (AP) isoforms are under development for the treatment of acute and chronic inflammatory diseases such as Rheumatoid Arthritis. Additionally, chronic degenerative diseases such as Alzheimer’s disease or Amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) are being considered promising therapeutic indications for alkaline phosphatases. Currently, ongoing clinical trials are being conducted with purified proteins from either bovine intestinal tissues or with non-naturally occurring reassembled recombinant versions of these molecules. The molecule developed by CEVEC, a recombinant wild-type version of a fully-human AP with a high, specific activity and a prolonged serum-half life, is expected to become the preferred alternative for these approaches.

The observed superior pharmacokinetic properties of CAP®Go derived PLAP hold promise to affect the therapeutic efficacy of the molecule. This may lead to a reduction in effective dosage and frequency of administration; two important factors that pose a challenge in chronic indications. Together with the outstanding CAP®Go production capabilities of up to 10 fold higher yields than conventional cell lines this new cell line enables the development of a highly efficacious and economic alkaline phosphatase based therapy. CEVEC plans to partner the further development of the molecule.

“The results with the recombinant placental human alkaline phosphatase show, once again, the potential of our recently launched proprietary CAP®Go technology,” commented Frank Ubags, Chief Executive Officer of CEVEC Pharmaceuticals GmbH. “The CAP®Go expression platform has already been shown to enhance the activity, stability and serum half-life of the recombinant C1 Inhibitor. Promising projects on other complex recombinant glycoproteins are progressing.”

About CEVEC:

Privately held CEVEC, based in Cologne, Germany, is an expert for the production of tailor-made recombinant glyco-proteins and gene therapy vectors. The Company’s core technologies, CAP®Go and CAP®GT are based on a unique human cellular expression system.

The CAP®Go expression platform comprises a portfolio of glyco-optimized human suspension cell lines for tailor-made glycosylation of recombinant proteins. The cells are highly efficient for the production of a broad range of difficult to express glycoproteins and provide authentic human post-translational modifications. CAP®Go has proven to enhance the activity, stability and serum half-life of several candidate proteins.

The CAP®GT expression platform provides a fully scalable, regulatory endorsed production system for gene therapy vectors. CAP®GT cells grow to high cell densities and show a broad viral propagation spectrum including lentivirus (LV), adenovirus (AV) and adeno-associated virus (AAV). Furthermore, CAP®GT enables easier scale-up and reduced production costs when compared to adherent cell culture systems.

Research collaborations with international pharmaceutical and biotechnology partners followed by licensing agreements for the technology form one revenue base for CEVEC. In addition, the Company provides contract manufacturing for the cGMP production in CAP®Go and CAP®GT cells.

Contact:

CEVEC Pharmaceuticals GmbH
Frank Ubags
Chief Executive Officer
T.:+49 221 46020800
E.: ubags@cevec.com

MC Services AG
Anne Hennecke
Public Relations
T.: +49 211 52925222
E.: anne.hennecke@mc-services.eu