Orgenesis (NASDAQ:ORGS) Inc said it has achieved its latest milestone in the second phase of its collaboration with the Hospital Infantil Universitario Niño Jesús in Madrid, Spain.
The milestone has been reached by completing the placement of an Orgenesis (NASDAQ:ORGS) Mobile Processing Unit and Lab (OMPUL) on site.
In a statement, Orgeneis said this OMPUL is the first in Europe that has been designed specifically to process Tumor Infiltrating Lymphocytes (TILs) and Mesenchymal Stem Cells (MSCs).
OMPULs are multi-purpose mobile autonomous good manufacturing practice (GMP) facilities intended to develop, optimize and process cell and gene therapies at the point of care.
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The company first signed a research and development collaboration with the pediatrics hospital in May 2020, which was established to create a point-of-care center (POCare Center).
The OMPUL was delivered in January 2022 and is expected to be operational following certification by the Spanish health authorities and regulatory bodies, which is anticipated in the second quarter of 2022.
The manufacture and processing of TILs at the point of care is expected to lead to significant development and manufacturing cost reductions for the hospital, Orgenesis said.
In turn, the OMPUL is also expected to contribute to a significant reduction in the cost of goods of other cell therapies, including the Celyvir therapy, an MSCs-based therapy that was licensed from the hospital in March 2021.
The cost of goods has been a major industry barrier to delivering TILs and other cell therapies to patients, many of whom have few alternative therapeutic options.
“We believe the installation of Orgenesis’ OMPULs is critical for the Hospital’s therapies to continue to develop at the point of care, while enabling the Hospital to retain control of the process, as well as delivering cell and gene therapies at a cost that is affordable for patients and healthcare providers,” said Orgenesis CEO Vered Caplan
“We are continuing to deliver Orgenesis OMPULs across our Point of Care Network globally. Through our POCare platform, we also enable hospitals and healthcare providers around the world to share data within the network. This decentralized manufacturing and collaboration model is expected to become a key factor for a quicker delivery of approved therapies at an affordable cost, which we believe will be a key enabler for unlocking the full potential of such cell and gene therapies.”
Dr. Manuel Ramírez, head of the pediatric advanced therapies unit at the hospital, noted that costs and manufacturing hurdles have inhibited the ability of solid-tumor patients to receive practical and sustainable solutions from the cell and gene therapy sector.
“We believe the OMPUL will help overcome these challenges and allow us to accelerate the process of developing therapies, by providing a scalable and cost-effective solution for development through commercialization,” he said.
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