Celyvir is under clinical development by Orgenesis and currently in Phase II for Neuroblastoma. According to GlobalData, Phase II drugs for Neuroblastoma have a 21% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Celyvir’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Celyvir overview

Celyvir was under investigation for the treatment of refractory solid tumors including metastatic neuroblastoma, metastatic osteogenic sarcoma, metastatic soft tissue sarcoma and metastatic rhabdomyosarcoma in children and adults. It is formulated as solution for injection and administered by intravenous route. The therapeutic candidate constitutes bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. It was under development for Ewing sarcoma with bone metastases or bone marrow.

Orgenesis overview

Orgenesis is a biotechnology company that develops cell and gene therapies for immuno-oncology, viral, metabolic and autoimmune, vascular and musculoskeletal and kidney diseases. It is investigating CD19 CAR-T program against B-Cell acute lymphoblastic leukemia (B-ALL) and lymphoma; metabolic optimized T-cells to treat lung cancer and melanoma; cellular vaccines for solid tumors and pancreatic cancer; CD19.22 CAR-T to treat B-ALL; and CAR-NK cells targeting multiple myeloma and ovarian cancer. The company is also evaluating programs against genital warts, anal dysplasia, chronic pancreatitis, liver, kidney and dermatological diseases, psoriasis, wound healing, osteoarthritis, and other disorders. Orhenesis utilizes POCare platform technology to improve the development of therapies. It works in partnership with academia, research institutes and hospitals. Orgenesis is headquartered in Germantown, Maryland, the US.

For a complete picture of Celyvir’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.