Pharma Focus Asia

Orgenesis Enters Second Phase of Collaboration with Hospital Infantil Universitario Niño Jesús

Friday, March 12, 2021

Orgenesis Inc., a global biotech company working to unlock the full potential of cell and gene therapies, announces that it has entered the planned second phase of a collaboration with Hospital Infantil Universitario Niño Jesús in Madrid, Spain. The collaboration is focused on an exclusive license agreement to further develop and commercialize the hospital’s proprietary Celyvir therapy for the treatment of solid tumors.

The agreement follows an initial collaboration between FIB Hospital Infantil Universitario Niño Jesús and Orgenesis to establish a point-of-care center leveraging the Orgenesis POCare Platform, announced in May 2020. The POCare Platform has been designed by Orgenesis to enable hospitals and healthcare facilities globally to develop, optimize and manufacture cell and gene therapies throughout a POC Network of global healthcare facilities.

“The Phase 1 trial data from children and adults with solid tumors indicates that Celyvir has a favorable safety profile and promotes disease stabilization,” said Dr. Manuel Ramírez MD, PhD, Head of the Pediatric Advanced Therapies Unit at the Hospital. “We have partnered with Orgenesis to rapidly develop Celyvir to its full potential. Both of our teams are dedicated to bringing groundbreaking cell and gene therapies, potentially starting with Celyvir, to patients worldwide through the Orgenesis POCare Network.”

The Celyvir therapy takes a new approach to the treatment of solid metastatic tumors. An oncolytic virotherapy is administered using autologous Mesenchymal Stem Cells (MSCs) obtained from bone marrow to improve the oncolytic virus potency. Oncolytic viruses are genetically modified viruses that induce targeted cancer-killing mechanisms. Traditionally, the intravenous administration of an unshielded oncolytic virus elicits an antiviral response. This leads to virus clearance without the desired oncolytic action. The bone marrow derived Celyvir therapy shields the virus using MSCs with reduced capacity to inhibit viral replication and viral load. These proprietary MSCs carry an oncolytic adenovirus (ICOVIR-5) that is designed to enhance oncolytic virus potency, to boost the acquired immune response and intensify the overall anti-tumor effect. This program represents a novel approach for the treatment of solid metastatic tumors, either as a monotherapy or in a combination with additional immunotherapies.

“Orgenesis has seen the potential of the Celyvir therapy to transform the treatment of solid metastatic tumors. This offers patients a lower toxicity profile and simpler treatment protocol. Aiding hospitals such as the Hospital Infantil Universitario Niño Jesús with developing these kind of therapies themselves is the exact reason why Orgenesis developed its POCare Platform,” said Vered Caplan, CEO of Orgenesis. “Now that the POCare Platform has demonstrated direct value to the Hospital Infantil Universitario Niño Jesús, we have decided to enter the second phase of the collaboration, and carry forward a long-term commitment to commercializing other promising immune-oncology therapies developed by the hospital.”

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