Posted on Wednesday, November 9, 2022

Autoimmune diseases: BioSenic provides an update on the developments of its TOA platformBioSenic, the company specializing in severe autoimmune/inflammatory diseases and cell repair, has just provided an update on its platform dedicated to systemic autoimmune diseases, initially designed by Medsenic. This update follows the announcement of the merger between Bone Therapeutics and Medsenic, as well as the listing of the Company on Euronext Brussels and Paris.

BioSenic’s autoimmune platform was developed to target systemic autoimmune diseases using Arsenic TriOxide (TOA). It uses the TOA mechanism of action, the first in its class to be used as an active anti-inflammatory and immunomodulatory agent.

“For 12 years now, Medsenic has been developing its platform dedicated to systemic autoimmune diseases in order to use the immunomodulatory properties of arsenic trioxide, whose characteristics as a small molecule are now well established”, says Professor François Rieger , Chairman and CEO of BioSenic. “Following the merger, BioSenic now intends to develop controlled dosages and new formulations suitable for a significant number of important indications with unmet medical needs. Above all, we seek to demonstrate that arsenic can potentially heal and save lives. By combining our two platforms, ALLOB from Bone Therapeutics and the new TOA platform from Medsenic, BioSenic will go through key stages of value creation, starting in the first half of 2023.”

The unique efficacy of TOA in creating lasting remission of a rare cancerous disease, Acute Promyelocytic Leukemia (APL), has already been recognized by the US Food and Drug Administration (FDA) and by the European Medicines Agency, and has already led to marketing authorizations. BioSenic is currently conducting further active clinical trials to evaluate TOA as a premier therapeutic active in autoimmune diseases.

There are two mechanisms of action of arsenic trioxide to counter autoimmunity and chronic inflammatory diseases. The first consists of a significant increase in the oxidative stress of activated immune cells, leading to their death. The second inhibits the synthesis and/or release of pro-inflammatory cytokines. The combination of these mechanisms of action significantly reduces inflammation and active autoimmunity. These immunomodulatory properties have significant and long-lasting effects on immune pathology in a number of autoimmune diseases. These effects have been amply demonstrated previously in animal models adapted by Medsenic and other organizations.

BioSenic’s portfolio today includes two platforms:

• The CSM ALLOB platform uses cells with immune privilege, anti-inflammatory properties and the ability to differentiate into bone tissue when injected directly into specific bone sites to be regenerated or repaired. The phase IIb trial evaluating ALLOB, a randomized, double-blind, placebo-controlled study in patients with high-risk tibial fractures, is still ongoing and is expected to report pivotal interim results in the first half of 2023.

• The platform dedicated to autoimmune diseases using TOA has completed a phase IIb trial showing positive results on the safety and efficacy of the product in 20 patients suffering from cGVHD (the chronic form of graft versus liver disease). host). Of note, in this corticosteroid-controlled trial, patients’ corticosteroid levels declined as early as six weeks after starting TOA treatment, reaching minimal levels.

“Medsenic/BioSenic recently completed a Phase II study evaluating Arsenic Trioxide in combination with corticosteroids as a first-line treatment for moderate to severe GvHD. Promising six-month response rates justify moving to a phase III study to expand available treatment options and reduce overall morbidity of chronic GvHD in transplant patients says Professor Corey Cutler, Medical Director of the Stem Cell Transplantation Program at the Dana Farber Cancer Institute in Boston and Harvard Medical School. Dr. Cutler is an expert in graft versus host disease.

The clinical results acquired and the results expected from the two platforms allow BioSenic to continue the preparation of confirmatory phase III studies, ahead of the launch of market access procedures with regulatory bodies in the United States and Europe. .

The cGvHD autoimmune disease platform’s Phase III study was designed to reach market as quickly as possible, including through the US Food and Drug Administration’s 505b2 fast-track regulatory pathway.

In addition to cGVHD, BioSenic is also preparing a randomized, placebo-controlled phase IIb study with TOA in systemic lupus erythematosus. This pathology has a high prevalence – the worldwide prevalence of SLE can reach 108 per 100,000 inhabitants and its incidence 5.14 per 100,000 inhabitants per year (Tian et al. 2022, Ann Reum, Dis.). It thus constitutes a potential strategic target for BioSenic. In addition, the promising preclinical data collected by Medsenic provides a solid basis for the initiation of a phase II clinical trial evaluating TOA in systemic sclerosis.

As a result, BioSenic expects the passage of key, value-creating milestones during the first half of 2023, in particular the interim results of phase IIb of ALLOB and the start of the phase III study of TOA in cGvHD. BioSenic will initiate the process of contacting industrial partners to co-develop late-stage clinical projects and to examine other segments of interest in autoimmune diseases and cancer.

Source and visual: BioSenic

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