BioSenic announced it has appointed Michel Wurm, MD, as interim Chief Medical Officer (CMO), responsible for the development of both of BioSenic's cell therapy and autoimmune disease platforms. Michel Wurm replaces Anne Leselbaum as interim CMO and as an independent consultant. His appointment will commence with immediate effect. Both Michel and Anne worked and collaborated closely together alongside the medical and scientific teams throughout the processes of the merger between Bone Therapeutics and Medsenic, from when the discussions between the two companies started in May 2022.

Michel will serve as CMO whilst BioSenic selects a permanent CMO from the list of candidates it is currently compiling. The new CMO will be selected for his/her expertise and experience in both autoimmunity and cell therapy. Michel has been selected as interim CMO primarily for his previous achievements for MedSenic.

He has acquired considerable knowledge of clinical development, specifically in phase II and III. In Michel's career, he has designed and managed over 50 international phase II and III clinical studies and has extensive experience in working within clinical guidelines for, and interacting with regulatory agencies including the FDA and EMA. Michel has also acquired experience in a number of therapeutic target areas including cardiovascular diseases, inflammation and auto-immunity.

Michel has also gained wider expertise in innovative drug development, including launching start-ups, filing patents, and raising funds for both private and public companies. Michel wrote the French adaption of ‘The Investigator's Guide to Clinical Research', a manual for investigators and health professionals involved in conducting clinical research, investigator financial disclosure, noncompliance issues, the FDA audit process and data collection technologies. As Michel has been instrumental in bringing together the clinical pipelines of Bone Therapeutics and Medsenic during the merger process, he has gained full working knowledge of the current clinical progress of the cell therapy platform ALLOB and has extensive working knowledge of the autoimmune platform using arsenic trioxide (ATO), and specifically its clinical development in cGvHD (chronic Graft vs Host Disease).

Michel will be immediately responsible for continued progression of both BioSenic assets: The ALLOB MSC platform using 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 IIb 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 H1 2023. Michel will progress this trial to the intermediary analysis stage.

This includes overall responsibility for liaising with the CRO nominated for the trial, and liaising with investigators in the thirty-five trial centers across seven EU countries. For the autoimmune ATO platform using ATO, Michel will also be focused on the start of the phase III trial in cGvHD, and will oversee the commencement of recruitment for the trial in a US center, to be selected shortly.