MolMed S.p.A. has announced that the European Patent Office granted a key patent covering the gene forming the basis of TK, MolMed's investigational cell therapy product currently in Phase III for the treatment of high-risk leukaemia.
The new European composition of matter patent (EP1781789) is part of a large patent family owned by MolMed and covers a non-splicing variant of the HSV-TK gene, i.e. a variant that is transcribed in a stable and unmodifiable manner.
The patent, affording patent protection until 2025 with the possibility of a 5-year term extension, guarantees market exclusivity in 29 designated countries within the European Patent Convention, including all major countries of the European Union, Switzerland and Turkey.
Equivalent patent applications are pending in the United States, Japan and important emerging markets.
Claudio Bordignon, MolMed's chairman and CEO, comments: "With the grant of this new European patent, MolMed obtains market exclusivity on a technology developed by our scientists, which assures that all TK cells are sensitive to the antiviral drug ganciclovir; this allows to promptly eliminate all TK cells in case of occurrence of Graft-versus-Host disease (GvHD) through administration of the drug. This full control of GvHD gives access to bone marrow transplantation to all patients lacking a fully matched donor."
The new European patent strengthens the intellectual property position of MolMed on TK, consisting of 11 patent families - all granted patents in Europe - covering the following components of the TK technology: the retroviral vector carrying the HSV-TK gene for therapeutic use, the non-splicing variants of the gene, the marking and selection of transduced human cells and all relevant production processes, including the manufacturing of TK cells in a closed system.
The overall TK intellectual property portfolio consists of a total of 137 granted patents and 16 pending applications.
This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14.5.1999 as subsequently amended.