DGAP-News: CEVEC's CAP(R)Go derived recombinant placental human alkaline phosphatase shows superior results in a preclinical study


DGAP-News: CEVEC Pharmaceuticals GmbH / Key word(s): Study/Study
results
CEVEC's CAP(R)Go derived recombinant placental human alkaline
phosphatase shows superior results in a preclinical study

06.07.2015 / 08:30

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CEVEC's CAP(R)Go derived recombinant placental human alkaline phosphatase
shows superior results in a preclinical study

  - New CAP(R)Go cell line for the production of glyco-optimized
    recombinant human alkaline phosphatase successfully established

  - CAP(R)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(R)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(R)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(R)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(R)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(R)Go technology," commented Frank Ubags, Chief Executive Officer of
CEVEC Pharmaceuticals GmbH. "The CAP(R)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(R)Go and CAP(R)GT are based
on a unique human cellular expression system.

The CAP(R)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(R)Go has proven to enhance the
activity, stability and serum half-life of several candidate proteins.

The CAP(R)GT expression platform provides a fully scalable, regulatory
endorsed production system for gene therapy vectors. CAP(R)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(R)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(R)Go and CAP(R)GT cells.

Contact:      
<pre>

CEVEC Pharmaceuticals GmbH                 MC Services AG
Frank Ubags                                Anne Hennecke
Chief Executive Officer                    Public Relations
T.:+49 221 46020800                        T.: +49 211 52925222
E.: ubags@cevec.com                        E.: anne.hennecke@mc-services.eu


</pre>
www.cevec.com



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