INmune Bio Inc.
(NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on
inflammation and immunology, today announced that it has entered into a Master
Services Agreement with Uniphar Durbin Ireland Limited (“Uniphar”) establishing
a scalable framework to support international access, distribution and
commercialization of Ebstrocel™, the Company’s allogeneic stromal cell therapy
for Recessive Dystrophic Epidermolysis Bullosa (RDEB). INmune Bio initially
intends to use the framework to pursue named-patient access in selected
European countries and in the Middle East and North Africa (MENA), subject to
applicable law and country-specific statements of work. The relationship may
subsequently expand across Europe and other territories by mutual agreement.
The Company expects
named-patient access to be an important component of its international
commercialization strategy for Ebstrocel™. Where permitted by local law and
implemented through statements of work, this pathway may allow physicians to
request Ebstrocel™ for individual eligible patients before local marketing
approval or broad commercial availability.
The Uniphar framework
is designed to provide the Company with scalable international commercial
infrastructure, beginning with named-patient supply, and potentially expanding
to broader commercial distribution as regulatory approvals, pricing and reimbursement
are secured in individual countries. Depending on the services agreed in
individual statements of work, Uniphar may support regulatory feasibility
assessments, market access, product storage and distribution,
healthcare-provider and treatment-site onboarding, order-to-cash services,
medical information, pharmacovigilance support and end-to-end shipment
tracking. By leveraging Uniphar’s established infrastructure rather than
building country-by-country capabilities internally, the Company believes this
model provides a capital-efficient path to establish Ebstrocel™’s international
commercial footprint and scale as additional markets become available.
“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.”
About Ebstrocel™
Ebstrocel™ (pobistrocel)
is INmune Bio’s investigational, pooled, allogeneic, human umbilical
cord-derived mesenchymal stromal cell therapy being developed through the
Company’s CORDStrom™ platform for the treatment of RDEB. The platform is
designed to address donor variability and manufacturing inconsistency.
Ebstrocel™ is investigational and has not been approved by the FDA, MHRA, EMA
or any other regulatory authority.
About Uniphar Plc.
Uniphar is a trusted
global partner to pharma, medtech and biotech, delivering solutions that
connect medicines and technologies with patients worldwide. With over 57 years
of experience and partnerships with 200+ multinational clients, Uniphar
combines deep expertise, global infrastructure and market insight to meet the
evolving needs of the life sciences sector.
Uniphar Pharma
integrates Development, Clinical, Access, Medical, Commercial, Distribution and
Global Sourcing to support the full product lifecycle – from early-stage
research through to commercialization and beyond. Uniphar’s unified platform
spans regulatory strategy, clinical trial support, medical affairs, market
access, patient engagement, commercial services, distribution and supply chain.
Operating across 160
countries with a global team of 3,600+, Uniphar bridges manufacturers,
healthcare providers, and patients — accelerating access to innovative
therapies, improving patient outcomes, and delivering value across the
healthcare ecosystem.
From molecule to
market and beyond.
About INmune Bio
Inc.
INmune Bio Inc. https://www.inmunebio.com/ is a
publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on
developing treatments that target the innate immune system to fight disease.
Moving beyond early-stage exploration, the Company’s clinical-development
strategy centers on advanced precision medicine, matching drug mechanisms
directly to patient biology to optimize clinical outcomes.
INmune Bio is actively
advancing two late-stage product platforms toward registrational milestones:
CORDStrom™: A proprietary, pooled,
allogeneic, human umbilical cord-derived mesenchymal stromal cell platform
engineered to address the historical clinical challenges of donor
variability and manufacturing inconsistency. Following successful clinical
readouts in RDEB, the platform is transitioning toward regulatory and
commercial readiness, with an MAA planned for the UK MHRA in 2026 and EU
EMA in 2027, alongside a planned U.S. regulatory pathway and development
of international access and distribution infrastructure.
XPro1595™: A Dominant-Negative Tumor
Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF
(sTNF) to reduce pathological neuroinflammation without compromising
protective immune function. Backed by recently granted FDA Fast Track designation
and successful regulatory alignment from an End-of-Phase 2 meeting,
XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive
registrational program in neuroinflammation-enriched early Alzheimer’s
disease.
To learn more about
INmune Bio’s pipeline and its approach to harnessing the innate immune system,
please visit www.inmunebio.com .
Forward Looking
Statements
The Company’s product
candidates are investigational, and there can be no assurance that any
clinical, regulatory or commercial objective will be achieved. Any statements
contained in this press release related to the development or commercialization
of product candidates and other business and financial matters, including
without limitation, trial results and data, timing of key milestones, future
plans or expectations, the scope and implementation of the Uniphar relationship,
the execution of statements of work, the availability and timing of
named-patient or expanded-access sales, potential revenue, potential expansion
across Europe or into Latin America, the anticipated capital efficiency of the
distribution model, and the prospects for receiving regulatory approval or
commercializing or selling any product or drug candidates, may constitute
forward-looking statements as that term is defined in the Private Securities
Litigation Reform Act of 1995. Any forward-looking statements contained herein
are based on current expectations but are subject to several risks and
uncertainties. Actual results and the timing of certain events and
circumstances may differ materially from those described by the forward-looking
statements because of these risks and uncertainties. CORDStrom™ (EbstrocelTM, pobistrocel),
XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical
trials, are still in clinical trials or are preparing to start clinical trials
and have not been approved by the US Food and Drug Administration (FDA), the UK
MHRA or any regulatory body and there cannot be any assurance that they will be
approved by the FDA, the UK MHRA or any regulatory body or that any specific
results will be achieved. The factors that could cause actual future results to
differ materially from current expectations include, but are not limited to,
risks and uncertainties relating to the Company’s ability to produce more drug
for clinical trials; the availability of substantial additional funding for the
Company to continue its operations and to conduct research and development,
clinical studies and future product commercialization; and the Company’s
business, research, product development, regulatory approval, marketing and
distribution plans and strategies. These and other factors are identified and
described in more detail in the Company’s filings with the Securities and
Exchange Commission, including the Company’s Annual Report on Form 10-K, the
Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on
Form 8-K. The Company assumes no obligation to update any forward-looking
statements to reflect any event or circumstance that may arise after the date
of this release.
This article was written by IL Contributors at investinglive.com.
