INmune Bio Celebrates Manufacturing Breakthrough
INmune Bio Inc. (NASDAQ: INMB) has marked an impressive achievement by successfully completing its inaugural pilot-scale manufacturing run of CORDStrom™ at a cutting-edge facility. This milestone represents not just a phase in production, but a great leap toward providing a vital therapy for patients battling Recessive Dystrophic Epidermolysis Bullosa (RDEB).
The Significance of CORDStrom™
CORDStrom™ is an innovative cell therapy developed from mesenchymal stromal cells derived from human umbilical cords. Designed to alleviate the severe symptoms associated with RDEB, this therapy targets the underlying skin fragility and promotes healing. Patients suffering from this condition often experience extreme skin blistering and complications that severely affect their quality of life, making therapies like CORDStrom™ critical.
High-Quality Production Standards
The recent pilot run took place at the Cell and Gene Therapy Catapult's advanced manufacturing center, reinforcing INmune Bio's commitment to high-quality production standards and GMP compliance. By utilizing a proprietary process, the company demonstrated the ability to produce CORDStrom™ consistently and at scale, vital for future distribution and accessibility.
Positive Clinical Outcomes
The convenience of CORDStrom™ is enhanced by its positive results from the Phase 2 Mission EB trial, which showed significant improvements in patient-reported symptoms such as pain, itching, and wound healing. Such promising data boosts the prospects for regulatory applications, providing hope to both clinicians and patients alike.
Looking Ahead: Regulatory Pathways
INmune Bio is forecasting an aggressive regulatory timeline. The successful pilot run keeps the company on target for submitting a Marketing Authorization Application (MAA) in the UK and a Biologics License Application (BLA) in the United States in the near future.
Voices from INmune Bio Leadership
Ben Weil, Head of UK Operations, expressed pride in the team's efforts and emphasized that the successful scale-up of production in a commercial-ready facility represents a significant step forward in getting this therapy to patients swiftly. Dr. Mark Lowdell, the Chief Scientific Officer, highlighted this milestone as fundamental to building a reliable supply chain for potential global distribution.
Empowering Patients with Innovative Solutions
The endeavors of INmune Bio are driven by the commitment to empower patients experiencing RDEB through significant therapeutic advancements. CORDStrom™ aims to offer a high-quality, ready-to-use therapeutic option for those in need.
Support from the Cell and Gene Therapy Catapult
Support from organizations like the Cell and Gene Therapy Catapult serves as a valuable asset to INmune Bio. Their collaboration helps refine production processes and navigate the complexities of commercial manufacturing, ultimately facilitating patient access to transformative therapies.
INmune Bio's Broader Mission
As a forward-thinking clinical-stage company, INmune Bio focuses on utilizing the innate immune system to combat diseases through its innovative platforms. Alongside CORDStrom™, INmune is also developing additional treatments aimed at tackling diseases such as Alzheimer’s and various cancers, showcasing a diverse pipeline committed to improving patient outcomes.
Company Contact Information
For more information about INmune Bio, you can reach out to:
David Moss
Chief Financial Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
Frequently Asked Questions
What is CORDStrom™?
CORDStrom™ is an allogeneic mesenchymal stromal cell therapy derived from human umbilical cords, designed to treat Recessive Dystrophic Epidermolysis Bullosa (RDEB).
What significance does the pilot run hold?
The successful pilot run signifies the ability to produce CORDStrom™ at scale, ensuring consistency and quality for regulatory submissions and patient access.
What are the next steps for INmune Bio?
INmune Bio plans to file regulatory applications for CORDStrom™ with the goal of bringing this therapy to market in the near future.
How does CORDStrom™ benefit RDEB patients?
This therapy aims to address skin fragility and chronic complications associated with RDEB, significantly improving patients' quality of life.
Who can I contact for more information about INmune Bio?
Contact David Moss or Daniel Carlson at INmune Bio for inquiries about the company and its therapies.
