BioSenic’s systemic autoimmune disease platform, originally designed by Medsenic, is now developing controlled dosages and new formulations adapted to a significant number of important indications with unmet medical needs.
BioSenic specializes in serious autoimmune and inflammatory diseases as well as cell repair. The update follows the announcement of the merger between Bone Therapeutics and Medsenic and the listing on Euronext Brussels and Paris.
The BioSenic autoimmune platform has been constructed to target systemic autoimmune diseases using arsenic trioxide (ATO). This uses ATO’s first-in-class mechanism of action as an active anti-inflammatory and immunomodulatory agent.
BioSenic autoimmune platform
“Medsenic has developed its systemic autoimmune disease platform over a 12-year period to utilize the immunomodulation properties of arsenic trioxide. The properties of ATO as a small molecule are now well established,” said François Rieger, president and CEO of BioSenic.
“Following the merger, BioSenic is now developing controlled dosages and new formulations that are adapted to a significant number of important indications with unmet medical needs. We are looking to demonstrate that arsenic can potentially cure and save lives. Combining both our platforms, ALLOB from Bone Therapeutics and the new ATO platform by Medsenic, BioSenic will trigger key value creation milestones during the first half of 2023.”
The efficacy of ATO to create long-lasting remission of a rare cancer condition, acute promyelocytic leukemia (APL), has been previously recognized by both U.S Food and Drug Administration (FDA) and European Medicines Agency (EMA), with market approvals. BioSenic is now further actively clinically testing ATO as a main therapeutic asset for autoimmune diseases.
Two mechanisms of action
There are two mechanisms of action of arsenic trioxide for counteracting autoimmunity and inflammatory chronic diseases. The first is a significant increase in oxidative stress of activated immune cells leading to their death. The second inhibits the synthesis and/or release of proinflammatory cytokines. By combining the mechanisms of action, inflammation and active autoimmunity is drastic decreased.
These immunomodulatory properties have important and long-lasting effects on the immune pathology in a number of autoimmune diseases. This has been extensively previously demonstrated in adequate animal models by Medsenic and other organizations.
BioSenic assets now comprise two platforms:
The ALLOB MSC platform uses cells with immune privilege, anti-inflammatory properties and the ability to differentiate into bone tissues when injected into the specific bone sites to be regenerated or repaired. The phase 2b trial of ALLOB, a randomized, double-blind, placebo-controlled study in patients with high-risk tibial fractures, is still ongoing and set to report important interim results in the first half of next year (2023).
BioSenic assets – two platforms
The autoimmune disease platform using ATO has completed a phase 2b trial with positive results on safety and efficacy in 20 patients for cGVHD (chronic Graft vs Host Disease). A headline result for this corticosteroid-controlled trial was that patient’s corticosteroids levels decreased as soon as six weeks following the start of the treatment with ATO, to reach minimal levels.
Corey Cutler is medical director of the stem cell transplantation program at Boston’s Dana Farber Cancer Institute and Harvard Medical School. His field of expertise is Graft Versus Host Disease.
Phase 3 study
He said: “Medsenic/BioSenic has recently completed a phase 2 study of Arsenic Trioxide in combination with corticosteroids as initial therapy for moderate-severe cGvHD. The promising response rates at six months justifies pursuing a phase 3 study, with a goal of broadening treatment options and reducing the overall morbidity of chronic GvHD in our transplant recipients.”
The acquired clinical results and expected results from both platforms enable BioSenic to move forward into confirmatory phase 3 studies prior to market access procedures with regulatory agencies in US and Europe.