Product name
Soluferon® for improved treatment of Multiple Sclerosis (VPM5001) from Vakzine Projekt Management GmbHSummary
6-fold higher bioavailability by introducing hydrophilic moietiesOrganization name
Vakzine Projekt Management GmbHProfile
Soluferon® is a 2nd generation modified interferon-ß with increased bioavailability, due to enhanced hydrophilic properties. It is well known that the major shortcomings of the currently marketed interferon-ß, namely limited efficacy and tolerability, have been attributed to their high hydrophobicity causing aggregation and antigenicity.
In order to improve the pharmacokinetic properties of Soluferon® the amino acid sequence of human interferon-ß was changed. In the non-functional portion of the molecule, nine hydrophobic amino acids were replaced by hydrophilic serine moieties. As a result hydrophobicity was reduced and bioavailability was increased up to six-fold when compared to human interferon-ß. In the antiviral assay Soluferon® displays the same specific antiviral activity as unmodified human interferon-ß.
The absence of immunoreactive sequences as demonstrated in algorhithmic analyses of the amino acid sequence indicates reduced antigenicity of Soluferon® as compared to marketed interferon-ß. Higher bioavailability promises better efficacy and tolerability, as it has been clinically demonstrated that higher interferon-ß doses lead to fewer relapses in MS.
The intended use of Soluferon® is in the “classic” interferon-ß indications, i.e. the treatment of Multiple Sclerosis (MS), but also in Hepatitis C, autoimmune diseases, and cancer. Multiple Sclerosis alone represents a > 4 billion US$ market. The improved properties of Soluferon® should result in a rapid and significant market penetration. The product is presently formulated as a solution for injection. Due to its novel properties, it is especially suitable for the preparation of long-acting (Sustained Release) inhalative and potentially transdermal formulations. The Intellectual property is protected until 2018. Soluferon is expressed in CHO-cells. The GMP manufacturing process is being finalised.
The compound is presently in preclinical testing and it is planned to initiate the clinical phase I in 2007. The available in-vitro and in-vivo data indicate that the biological activity of Soluferon® is equivalent to that of the natural IFN-ß and IFN-ß 1a, combined with a significantly improved bioavailability.
One potential competitor has been discontinued in development. Several different molecules are presently in development. However, these are mostly early stage new compounds with lengthy development processes and high risk of failure.
Soluferon® is member of the well-established IFN-ß class, yet has markedly improved properties. Together it makes Soluferon® a promising candidate for a better treatment of MS in the future.
Soluferon® is the registered international trade mark of Vakzine Projekt Management GmbH (VPM). The substance was developed at and patented by Fraunhofer-Institut für Grenzflächen- und Bioverfahrenstechnik, Stuttgart/Hannover. Both European (PCT/EP98/02238) and US Patents (US6572853B1 and US7052687B2) have been granted with a Patent life until April 2018. VPM holds the exclusive and worldwide license to this patent family. Freedom to operate has been evaluated with respect to substance, manufacturing, formulation and use.
Contact
Vakzine Projekt Management GmbH
Dr. Leander Grode
grode(at)vakzine-manager.de
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