Key Facts
- INmune Bio (NASDAQ: INMB) has signed a Master Services Agreement with Uniphar Durbin Ireland Limited covering international access, distribution and commercialisation of Ebstrocel™.
- Ebstrocel™ is an investigational allogeneic stromal cell therapy for recessive dystrophic epidermolysis bullosa (RDEB) and has not been approved by any regulator.
- The first use of the framework is named-patient access in selected European and MENA countries, subject to local law and country-specific statements of work.
- INmune Bio plans a marketing authorisation application to the UK MHRA in 2026 and to the EU EMA in 2027.
- Uniphar works across 160 countries with more than 3,600 staff and 200+ multinational clients.
Boca Raton, Florida, 21 October 2026 – Late-stage inflammation and immunology biotech INmune Bio Inc. (NASDAQ: INMB) has signed a Master Services Agreement with Uniphar Durbin Ireland Limited (“Uniphar”), creating a scalable framework for international access, distribution and commercialisation of Ebstrocel™, its allogeneic stromal cell therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB).
INmune Bio intends to use the framework first to seek named-patient access in selected European countries and in the Middle East and North Africa (MENA), subject to applicable law and to statements of work agreed country by country. By mutual agreement, the relationship could later widen across Europe and into other territories. The announcement concerns launch preparation, not a regulatory approval.
Named-patient access as the opening route
The company expects named-patient access to form an important part of its international commercialisation strategy for Ebstrocel™. Where local law allows and a statement of work is in place, this route may let physicians request the therapy for individual eligible patients before local marketing approval or broad commercial availability.
The Uniphar arrangement is built to give INmune Bio international commercial infrastructure that can scale, starting with named-patient supply and potentially moving into wider commercial distribution as approvals, pricing and reimbursement are secured in each country. Depending on the services set out in individual statements of work, Uniphar may handle regulatory feasibility assessments, market access, product storage and distribution, onboarding of healthcare providers and treatment sites, order-to-cash services, medical information, pharmacovigilance support and end-to-end shipment tracking. The company believes using Uniphar’s existing infrastructure, rather than building capabilities market by market, is a capital-efficient way to establish Ebstrocel™’s international footprint and scale as markets open.
What the two companies said
“This agreement marks an important step in moving Ebstrocel™ from clinical development toward commercialization and bringing Ebstrocel to patients internationally,” said David Moss, Chief Executive Officer of INmune Bio. “Uniphar provides access to established market-access, distribution and order-to-cash capabilities across multiple international markets without requiring INmune Bio to build those capabilities country by country. We believe this provides a capital-efficient way to pursue named-patient opportunities in appropriate markets while building the physician relationships, treatment-center experience and commercial infrastructure needed to support broader international commercialization.”
“We are pleased to partner with INmune Bio as it prepares Ebstrocel for international commercialization,” said Ruth Rostron, Head of Expanded Access at Uniphar. “Uniphar has built an integrated global platform to help innovative medicines navigate the complexities of international access, distribution and commercialization. We believe our infrastructure and experience are well suited to support INmune Bio’s strategy for Ebstrocel, beginning with named-patient access opportunities and expanding as the product progresses through its regulatory and commercial journey.”
How named-patient supply differs from compassionate use
In the EU, named-patient supply differs from formal compassionate use. The European Medicines Agency notes that compassionate use programmes cover groups of patients and are coordinated by Member States under their own rules, whereas named-patient treatment is arranged case by case under the direct responsibility of the doctor, with no need to inform the Agency. For investors tracking names such as Moderna’s cancer vaccine push or Novo Nordisk’s pipeline spending, the pre-approval build is where execution risk shifts from lab to logistics.
About Ebstrocel™
Ebstrocel™ (pobistrocel) is INmune Bio’s investigational, pooled, allogeneic mesenchymal stromal cell therapy derived from human umbilical cord, developed on the company’s CORDStrom™ platform to treat RDEB. The platform is designed to tackle donor variability and inconsistent manufacturing. Ebstrocel™ remains investigational and has not been approved by the FDA, MHRA, EMA or any other regulator.
About Uniphar
Uniphar describes itself as a global partner to pharmaceutical, medtech and biotech companies, linking medicines and technologies with patients around the world. It has more than 57 years of experience and over 200 multinational clients, combining expertise, global infrastructure and market insight for the life sciences sector.
Uniphar Pharma brings together Development, Clinical, Access, Medical, Commercial, Distribution and Global Sourcing to cover the whole product lifecycle, from early research through commercialisation and beyond. Its single platform covers regulatory strategy, clinical trial support, medical affairs, market access, patient engagement, commercial services, distribution and supply chain. With operations in 160 countries and a team of more than 3,600 people, Uniphar connects manufacturers, healthcare providers and patients to speed up access to new therapies.
About INmune Bio
INmune Bio Inc. is a NASDAQ-listed (INMB), late-stage biotechnology company developing treatments that target the innate immune system. Its clinical strategy centres on precision medicine, matching drug mechanisms to patient biology. The company is advancing two late-stage platforms towards registrational milestones.
CORDStrom™ is a proprietary, pooled, allogeneic, umbilical cord-derived mesenchymal stromal cell platform engineered to overcome the historical problems of donor variability and manufacturing inconsistency. After successful clinical readouts in RDEB, it is moving towards regulatory and commercial readiness, with a marketing authorisation application planned for the UK MHRA in 2026 and the EU EMA in 2027, alongside a planned US regulatory pathway and the build-out of international access and distribution infrastructure.
XPro1595™ is a Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralises soluble TNF to curb pathological neuroinflammation without weakening protective immune function. Supported by a recently granted FDA Fast Track designation and regulatory alignment following an End-of-Phase 2 meeting, XPro1595™ is set up for an integrated, seamless adaptive Phase 2b/3 registrational programme in early Alzheimer’s disease enriched for neuroinflammation.
Frequently Asked Questions
Has Ebstrocel been approved?
No. Ebstrocel™ remains an investigational therapy and has not been approved by the FDA, the UK MHRA, the EMA or any other regulator. INmune Bio plans a marketing authorisation application to the MHRA in 2026 and to the EMA in 2027, with a US regulatory pathway also planned. The Uniphar agreement prepares commercial infrastructure ahead of those decisions.
What is named-patient access?
Named-patient access is a route through which physicians may request a therapy for individual eligible patients before it has local marketing approval or broad commercial availability. INmune Bio plans to pursue it first in selected European and MENA countries, only where local law permits and once country-specific statements of work are agreed with Uniphar.
What will Uniphar do for INmune Bio?
Depending on each statement of work, Uniphar may provide regulatory feasibility assessments, market access, storage and distribution, onboarding of healthcare providers and treatment sites, order-to-cash services, medical information, pharmacovigilance support and end-to-end shipment tracking, letting INmune Bio avoid building those capabilities country by country.
