Japan Grants Medsenic/BioSenic Patent for Therapeutic Platform

BioSenic, a clinical-stage biotechnology company based in Mont-Saint-Guibert, Belgium, has announced the receipt of a significant new patent from the Japan Patent Office. This patent extends the protection of their arsenic trioxide (ATO) platform, specifically in combination with metal ions such as copper. This innovative combination has demonstrated substantial potential in treating autoimmune diseases, various forms of cancer, and infectious diseases marked by cytokine storms. Prior to this, BioSenic secured similar patents in Europe, Australia, and China, which cover uses beyond the initial focus on graft-versus-host disease (GvHD).

BioSenic has been actively exploring the therapeutic applications of ATO across several conditions. Recent preclinical studies have provided insights into ATO's mechanisms for modulating immune responses and the role of metal ions in enhancing its therapeutic effects. This expanding portfolio of intellectual property rights aligns with BioSenic's strategic goal of creating robust protection for its leading product, thus paving the way for future clinical and commercial developments.

The newly granted patent, administered by BioSenic’s subsidiary Medsenic, targets two primary areas of application. The first is the treatment of immune and autoimmune diseases, with a leading project focused on chronic GvHD slated for 2024, followed by systemic sclerosis and systemic lupus erythematosus. The second area is oncology, where ATO has already proven effective, achieving complete remission in cases of acute promyelocytic leukemia. These patents will support BioSenic's plans for international clinical trials targeting diseases with unmet medical needs, aiming for market approval of its formulations that optimize the therapeutic properties of arsenic salts.

François Rieger, PhD, Chairman and CEO of BioSenic, highlighted the importance of the new patent for Japan in strengthening their intellectual property related to arsenic salts. He emphasized the potential of these formulations to normalize functions in various cells and organs, contributing to the global effort to manage chronic and lethal diseases with no current cures.

The development of an oral formulation that combines arsenic and copper further positions BioSenic to enhance its clinical success. This new formulation is expected to increase the potency of treatments while minimizing side effects, thus allowing BioSenic to continue progressing its clinical development with proprietary formulations that incorporate metal ions.

The Japanese patent, corresponding to Application 2021-569115 filed on May 20, 2020, is now officially granted to Medsenic. This follows the grant of similar patents by the European Union Intellectual Property Office in April 2023, the China National Intellectual Property Administration in August 2023, and the Australian and Canadian Patent Offices in December 2023.

BioSenic, through its Medsenic subsidiary, focuses on developing clinical assets based on the ATO platform. Key indications for their autoimmune platform include GvHD, systemic lupus erythematosus, and now systemic sclerosis. Following a merger in October 2022, BioSenic combined the strategic approaches of Medsenic and Bone Therapeutics, enabling the development of various anti-inflammatory and anti-autoimmune formulations utilizing the immunomodulatory properties of ATO and oral ATO (OATO).

The ATO platform offers derived active products with significant immunomodulatory properties, essential for treating immune-related conditions. One direct application of this technology is the treatment of chronic GvHD, a major complication affecting the long-term survival of patients undergoing allogeneic hematopoietic stem cell transplantation. Medsenic has successfully completed a phase 2 trial with its intravenous formulation, Arscimed®, which has been granted orphan drug designation by the FDA and EMA. The company is now moving towards an international phase 3 study with its new proprietary OATO formulation.

BioSenic is currently focusing its R&D and clinical efforts on rapidly advancing its autoimmune platform, aiming to address moderate-to-severe forms of systemic lupus erythematosus and systemic sclerosis. Preclinical studies have shown positive results, supporting the launch of phase 2 clinical trials using new immunomodulatory formulations.