At a Glance
- INmune Bio submits MHRA pre-submission package for CORDStrom, targeting first systemic RDEB therapy.
- MissionEB trial shows itch/pain relief, better skin integrity, and no serious adverse events.
- Three commercial manufacturing runs completed, confirming supply readiness for mid-2026 MAA.
- S. PRV program reauthorized through 2029, boosting BLA path for RDEB orphan designation.
Written By: Nikita Chaudhari BPharm
Reviewed By: Pharmacally Editorial Team
INmune Bio Inc., a clinical-stage inflammation and immunology company, has submitted a pre-submission package for CORDStrom™ to the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). This step is designed to obtain early regulatory feedback and streamline preparation of a full Marketing Authorization Application (MAA) for recessive dystrophic epidermolysis bullosa (RDEB), a rare genetic skin disorder with no approved systemic therapies.
RDEB, often referred to as “butterfly skin” disease, affects approximately 1 in 1 million births worldwide. Patients experience severe skin fragility, chronic wounds, intense itch and pain, gastrointestinal complications, and an elevated risk of aggressive skin cancers. Current management remains largely supportive, relying on topical wound care while systemic tissue damage continues to progress.
Strong Clinical and Manufacturing Foundation
The MHRA submission builds on positive findings from the MissionEB clinical trial (ISRCTN14409785), which demonstrated improvements in itch, pain, skin integrity, and patient-reported quality of life. CORDStrom was generally well tolerated, with no treatment-related serious adverse events reported.
To support commercial readiness, INmune Bio completed three commercial pilot-scale manufacturing runs at the CGT Catapult facility in Stevenage, UK. Each batch met predefined release specifications, reinforcing product consistency and scalability.
“This milestone positions us to potentially deliver the first systemic therapy for RDEB, beginning in the UK,” said Professor Mark Lowdell, PhD, FRCPath FRSB, Co-Founder and Chief Scientific Officer.
The company plans to submit its full MAA to MHRA by mid-summer 2026, followed by regulatory filings in the EU and U.S. in Q4 2026.
U.S. Incentives Strengthen Development Strategy
CORDStrom has received Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation from the U.S. Food and Drug Administration (FDA) for epidermolysis bullosa (EB).
Recent U.S. legislation passed on February 3, 2026, under the Mikaela Naylon Give Kids a Chance Act, reauthorized the Rare Pediatric Disease Priority Review Voucher (PRV) program through September 30, 2029. The transferable voucher mechanism is intended to accelerate FDA reviews and incentivize development of therapies for rare pediatric diseases.
CEO David Moss stated, “This bipartisan action strengthens our regulatory pathway as we prepare for a BLA submission later this year.”
About CORDStrom™
CORDStrom™ is an off-the-shelf, allogeneic cell therapy composed of pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs). The company’s proprietary platform is designed to support batch consistency, scalability, and potency across inflammatory indications. Future product iterations may be optimized for specific biological effects, including anti-inflammatory and wound-healing properties.
INmune Bio aims to shift the treatment paradigm in RDEB by targeting underlying systemic inflammation and multi-organ tissue damage rather than focusing solely on symptomatic wound care.
Reference
INmune Bio Advances CORDStrom™ Towards UK Marketing Authorization in RDEB, 10 February 2026, https://www.inmunebio.com/index.php/newsroom/2026-news/muneiodvancestromowardsarketinguthor20260210050501
Mesenchymal stromal cell therapy for children with recessive dystrophic epidermolysis bullosa, ISRCTN No. ISRCTN14409785, https://www.isrctn.com/ISRCTN14409785