EU Approval Of Mesenchymal Stromal Cell Therapy Manufacturing Protocol Using nLiven Human Platelet Lysate For A Phase 1B Clinical Trial
Sexton Biotechnologies and CCMI Galway collaborative effort leads to approval by EU regulatory authorities for the use of nLiven PR in the expansion of an allogeneic MSC therapeutic product to address corneal transplant rejection
INDIANAPOLIS and GALWAY, Ireland, July 10, 2020 /PRNewswire/ -- The Centre for Cell Manufacturing Ireland (CCMI) at the National University of Ireland Galway (NUI Galway) and Sexton Biotechnologies today announced the approval by an EU Regulatory Authority of a protocol for the manufacture of allogeneic bone marrow mesenchymal stromal cells (MSCs) to be given intravenously to high-risk corneal transplant recipients in the VISICORT Phase 1B clinical trial. For the VISICORT trial, CCMI will manufacture healthy donor (allogeneic) bone marrow MSCs using culture medium enriched with Sexton Biotechnologies' proprietary nLiven PR culture supplement. The MSCs will subsequently be cryopreserved (frozen) and transported to the Charité University Hospital Ophthalmology Department in Berlin, Germany where the trial is to be conducted. Patients with failure of a previous corneal transplant who agree to participate in the VISICORT trial will receive intravenous infusions of MSCs seven days and one day before a full thickness corneal re-transplant. Approval for the cell manufacturing protocol that incorporates the use of nLiven PR human platelet lysate supplement was recently given by the German Regulatory Authority, the Paul Ehrlich Institute (PEI).
Diseases of the cornea are one of the most common causes of visual loss and blindness worldwide and, when severe, require a corneal transplant to restore sight. Although the healthy cornea is protected from damage by the immune system, corneal transplants may be damaged by immune-mediated rejection, which remains the leading cause of corneal transplant failure. Experimental research carried out at NUI Galway over the past 10 years has shown that allogeneic MSCs can suppress the immune response to corneal transplants and prevent rejection. The VISICORT Phase 1B trial will be first human clinical trial to test the safety and feasibility of this cell therapy approach for high-risk corneal transplant patients.
Professor Matthew Griffin of NUI Galway is the coordinator of the VISICORT project has worked closely with the CCMI technical team, led by Mr. Andrew Finnerty, who developed the approved manufacturing protocol. Commenting on the regulatory approval, Prof. Griffin said "Safety and consistent quality and availability are paramount to successful manufacture of clinical-grade cell therapy products that meet the rigorous standards of our regulatory authorities. For this complex project, we are very pleased to have a reliable manufacturing process that meets these standards and is not reliant on small-batch culture supplements. We look forward to successful manufacture of allogeneic MSC doses for VISICORT and to the potential application of this cell therapy product to other challenging immune-mediated health conditions."
Steven Thompson, Vice President of Sales and Product Management at Sexton Biotechnologies, said "We are very excited to learn of the approval by PEI of the VISICORT Phase 1B Clinical Trial. Whilst our non-irradiated human platelet lysate product, Stemulate, had been used to manufacture cells for multiple clinical trials throughout the globe, recent guidance around pooled blood products drove a need for an irradiated version of the product. VISICORT will be the first EU-approved trial using our proprietary irradiation product, nLiven PR, and hence represents a major milestone for the product. We would very much like to thank our colleagues at CCMI for their collaborative spirit and persistence in making this happen and look forward to continuing to support them through Phase I and beyond"
ABOUT SEXTON BIOTECHNOLOGIES
Sexton Biotechnologies is a revenue stage, biotechnology company focused on the development and sales of bioproduction tools for cell and gene therapy founded in 2019 as a spin out of Cook Regentec, a life science incubator/accelerator located in Indianapolis, IN. Sexton develops purpose-built CGT tools and media to enable flexible automation and scaling of cell manufacturing processes to increase the probability of positive clinical outcomes and reduce time-to-market, failure points, and labor costs. Sexton's portfolio includes the CellSeal platform of cryo-storage tools and fill/finish systems and human platelet lysate growth supplements. More information at www.sextonbio.com.