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Orgenesis, Spanish Hospital to Develop, Commercialize Mesenchymal Stem Cell-Based Cell Therapy

NEW YORK – Orgenesis on Thursday said it has inked an exclusive licensing agreement with Hospital Infantil Universitario Nino Jesus for the development and commercialization of the Madrid-based hospital's cell therapy.

The treatment, called Celyvir, was originally developed by the hospital and involves administering an oncolytic virus shielded within bone marrow-derived autologous mesenchymal stem cells (MSCs). The treatment has demonstrated safety and disease stabilization in a Phase I/II trial involving children and adults with solid tumors.

According to the partners, using MSCs allows for the delivery of a more potent cancer-killing virus that isn't quickly cleared by the immune system, as commonly happens with intravenous administration of an unshielded oncovirus. The company and hospital plan to develop the autologous treatment for patients with metastatic solid tumors as monotherapy or together with other immunotherapies.

The licensing agreement marks the second phase of an ongoing collaboration between Germantown, Maryland-based Orgenesis and the Spanish hospital. Orgenesis has already helped the hospital establish a point-of-care center to develop and manufacture cell and gene therapies. The hospital has adopted Orgenesis' POCare Platform and joined its global POCare network of healthcare facilities for manufacturing and administering cell and gene therapies.

The Celyvir licensing agreement expands this collaboration, contingent on the successful development and validation of T-cell and dendritic cell-based therapies.

"Orgenesis has seen the potential of the Celyvir therapy to transform the treatment of solid metastatic tumors," Orgenesis' CEO Vered Caplan said in a statement. "This offers patients a lower toxicity profile and simpler treatment protocol."