BioSenic, a company specializing in serious autoimmune /inflammatory diseases and cell repair, 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.
 
Wurm replaces Anne Leselbaum as interim CMO and as an independent consultant. His appointment will commence with immediate effect. Both Wurm and Leselbaum 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. Wurm 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.
 
“Now the merger is complete, BioSenic is fully focused on combining its clinical development pipelines from its cell therapy and autoimmune platforms. Michel’s experience working within the clinical development team throughout the merger makes him the ideal candidate to drive the cell therapy platform ALLOB to the end of its phase IIb trial and start the phase III trial for our autoimmune platform, the following successful conclusion of the previous phase II trial. His years of expertise both in phase II and III clinical trials will be critical in this period for BioSenic,” said Prof. François Rieger, President and CEO of BioSenic.
 
He continued, “Michel’s experience means he will be best placed to prepare BioSenic to take full advantage of the results of the ALLOB phase IIb trial following completion, as well as conduct the most thorough preparation of the phase III trial for our autoimmune platform. These clinical developments will be key value creation milestones for BioSenic in the first half of 2023. This late-stage clinical progression will enable BioSenic to start the process of engaging with industrial partners to co-develop late-stage clinical projects and to look at other segments of interest in autoimmune diseases and cancer. I would like to thank Anne Leselbaum for her dedicated efforts during the merger until its completion.”

About Michel Wurm

Wurm 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 Wurm’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. Wurm has also acquired experience in a number of therapeutic target areas including cardiovascular diseases, inflammation and auto-immunity. Wurm has also gained wider expertise in innovative drug development, including launching start-ups, filing patents, and raising funds for both private and public companies. Wurm 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 Wurm 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).

Responsibilities

Wurm 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. Wurm 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, Wurm 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.

 
“BioSenic, through its merger, has acquired two platforms in cell therapy and autoimmune diseases. This has created an opportunity to cross-pollinate the experiences of both teams to drive through clinical development on our varied pipeline quickly. As CMO, I will now be responsible for driving through clinical candidates that can affect a wide spread of patients suffering from a range of conditions and make a meaningful difference to the lives of large numbers of patients,” said Wurm.
 
He added, “A successful conclusion of the phase IIb trial for ALLOB and the start of the phase III trial for the autoimmune platform will be major milestones for BioSenic as well. This will include further investigation of the medical characteristics and mechanisms of action of the therapies. I will be determined to enable BioSenic to recruit and progress this trial quickly and reduce analysis time and increase the clarity of results. This will move us towards the market as quickly as possible.”