BioSenic identifies key biomarkers for cGvHD and submits patent to EPO

INSIDE INFORMATION

International patent to allow the development of an industrial biomarker analysis kit which could generate a turnover of 30 to 40 million euros globally

Mont-Saint-Guibert, Belgium, May 4^th 2023, 7.00am CET – BioSenic (Euronext Brussels and Paris: BIOS), the clinical stage company specializing in serious autoimmune and inflammatory diseases and cell repair, today announces the submission of a key patent in the use of its ATO platform. The patent, entitled Diagnostic method for detecting the pathological correlates of chronic graft-versus-host disease (cGvHD) using particular cytokine or chemokine biomarkers, has been submitted at the European Patent Office desk (EPO). This patent covers the use of a new quantitative method to evaluate the impact of medications destined at changing the course of the chronic form of the Graft versus Host Disease (cGvHD).
In 2021, BioSenic successfully concluded a prospective national multicenter single-arm open-label Phase II study in 5 university hospital centers in France. In the trial, BioSenic treated 21 cGvHD patients with an intravenous formulation, known as Arscimed, of arsenic trioxide (ATO). BioSenic published positive safety and efficacy results in the international peer-reviewed journal Transplantation and Cellular Therapy. Subsequent analysis of patient serums now provides key data on the transition of cytokines/chemokines concentrations from an initial abnormal range of values to a normalized level, associated with reduced disease activity. Data of the post-hoc study are now available. These biomarkers will potentially help estimate the risk of developing the disease at early stages with measured levels of selected cytokines, and also to assess the therapeutic response to current standard of care or any new treatment.

“BioSenic's newly submitted patent will allow the company to accelerate the development and approval of its novel therapeutic agents in cGvHD. This patent covers quantitative research tools that are needed to evaluate short-term responses to treatments and to predict long-term clinical benefits,” said Prof. François Rieger, PhD, Chairman and Chief Executive Officer of BioSenic. “Regulatory agencies will be far more receptive to market approvals for treatment use of any active pharmacological ingredient if the means of quantitative monitoring of the assessment of the activity and direct staging of the disease are applicable. This patent adds to our extensive patent portfolio covering both of our therapeutic platforms. It will also be invaluable in our Phase 3 clinical trial using an oral formulation of ATO that is on target to start this year. Using this new disclosed quantitative method for the evaluation of disease activity will be a strong advantage to firmly establish the validity of any new experimental treatment.”