Viacure Therapeutics, a spin-off from Helmholtz Munich, is preparing a new antibody therapy for type 2 diabetes for clinical testing. The therapy is designed to protect insulin-producing beta cells and restore their function.

In type 2 diabetes, the body’s cells respond poorly to insulin. As a result, the insulin-producing beta cells in the pancreas must produce more insulin. As the disease progresses, these cells may progressively lose their function or be lost altogether, leaving the body unable to produce sufficient insulin. Viacure Therapeutics is targeting the beta cells directly: its antibody therapy is designed to preserve or regenerate beta cells and their function, thereby supporting the body’s own regulation of blood glucose.

As part of a collaborative research project funded by the Free State of Saxony and the European Union, Viacure Therapeutics, together with Fraunhofer IZI and CUP Laboratorien Dr. Freitag GmbH, aims to complete preclinical development and lay the groundwork for a first clinical trial.

Fraunhofer IZI is contributing its extensive expertise in the development and GMP-compliant manufacturing of therapeutic antibodies. The institute will establish a GMP-compliant manufacturing process, including the required quality-control analyses, and produce the investigational medicinal products. In addition, Fraunhofer IZI will conduct preclinical studies to evaluate the therapy’s efficacy and potential toxicity in various animal models. The safety assessment of the therapeutic antibody at Fraunhofer IZI’s GLP testing facility is a prerequisite for approval of the clinical trial.

The collaborative project, coordinated by Viacure Therapeutics, will run for two and a half years. It is funded by the Saxon State Ministry for Economic Affairs, Labor, Energy and Climate Protection (SMWA) through funds from the Free State of Saxony and the European Union under the Strategic Technologies for Europe Platform (STEP) regulation.