Omidubicel is under clinical development by Gamida Cell and currently in Phase II for Sickle Cell Disease. According to GlobalData, Phase II drugs for Sickle Cell Disease have a 59% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Omidubicel’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.

Omidubicel overview

Omidubicel (Omisirge) is a hematological agents. It is formulated as suspension for infusion for intravenous route of administration. Omisirge is indicated for the treatment in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

Omidubicel (Nicord) is under development for the treatment of hemoglobinopathies including sickle cell disease, beta-thalassemia and hematological malignancies like chronic myelocytic leukemia (CML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS) and for the use in hematopoietic stem cell transplantation. The therapeutic candidate is administered as an infusion. It is an allogeneic ex-vivo-expanded umbilical cord blood-derived hematopoietic CD34 positive progenitor cells and allogeneic non-expanded umbilical cord blood-derived hematopoietic mature myeloid and lymphoid cells. The therapeutic candidate is developed based on NAM platform technology. It was also under development for the treatment of Hodgkin lymphoma and non-Hodgkin lymphoma, acute myelocytic leukemia (AML).

Gamida Cell overview

Gamida Cell (Gamida) is a health care company. It offers cell therapy developing cell and immune therapy technologies for treating blood cancers and serious blood disorders. Its pipeline products include Omidubicel, GDA-201. Omnidibicel is an advanced cell therapy being developed as an allogeneic hematopoietic stem cell (bone marrow) transplant solution for treating hematologic malignancies and severe aplastic anemia. GDA-201 an innate natural killer cell immunotherapy used for the treatment of hematologic and solid tumors. Gamida utilizes NAM technology platform to develop its products. Gamida is headquartered in Jerusalem, Israel.

For a complete picture of Omidubicel’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.