INmune Bio taps Sanofi's U.S. rare-disease chief for board ahead of Ebstrocel launch

INmune Bio adds a Sanofi rare-disease lead to its board

INmune Bio (NASDAQ: INMB) appointed R. Duane Clark II and James Sapirstein, R.Ph., MBA, to its Board of Directors on Sept. 14, 2026, recruiting the two executives specifically to prepare the company for a potential rare-disease launch of Ebstrocel. Clark is General Manager, U.S. Rare Diseases at Sanofi, where he leads a multi-billion-dollar franchise spanning seven rare-disease brands with full profit-and-loss responsibility and has overseen product launches, market access and M&A integration. Sapirstein brings more than 40 years of biopharma leadership, including six global product launches and prior senior roles at Gilead Sciences, Bristol Myers Squibb, Hoffmann-La Roche, Eli Lilly and Serono Laboratories. He also founded Tobira Therapeutics, which Allergan later acquired in a deal valued at up to approximately $1.7 billion in total potential consideration. INmune Bio CEO David Moss said the pair add practical experience "to help us translate development progress into potential patient and shareholder value," with Clark focused on market access for Ebstrocel in recessive dystrophic epidermolysis bullosa (RDEB) and Sapirstein steering licensing, financing and broader deal work across the pipeline.

Rare-disease franchise and Ebstrocel commercialization focus

Clark's remit at INmune Bio will center on guiding market access, pricing, patient identification and launch execution for Ebstrocel in RDEB and potential additional rare-disease indications. The company framed the recruitment of a sitting Sanofi general manager as a direct infusion of commercial infrastructure at the point the therapy moves from clinical readouts toward registrational filings. Sapirstein's six global product launches and more than 20 additional launch participations were cited by the company as central to aligning clinical, regulatory, manufacturing and commercial functions ahead of a market entry.

CORDStrom and XPro1595 late-stage pipeline milestones

The board expansion comes as INmune Bio pushes two late-stage platforms toward regulatory submissions. CORDStrom has produced successful clinical readouts in RDEB, with planned MAA submissions to the UK MHRA in 2026 and to the EU EMA in 2027, plus a planned U.S. BLA. Separately, XPro1595 holds FDA Fast Track designation and End-of-Phase 2 regulatory alignment for an integrated Phase 2b/3 seamless adaptive registrational program in early Alzheimer's disease with neuroinflammation.

Other developments

Earlier in his career, Clark led Sanofi's U.K. and Ireland multiple sclerosis business and held commercial and business-development roles at CTI Clinical Trial & Consulting Services, Encysive Pharmaceuticals, Astellas Pharma, Ortho Biotech and Marion Laboratories, according to the same Sept. 14 announcement carried across financial outlets.