CB-5339 is under clinical development by CASI Pharmaceuticals and currently in Phase I for Relapsed Acute Myeloid Leukemia. According to GlobalData, Phase I drugs for Relapsed Acute Myeloid Leukemia have a 70% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how CB-5339’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.

CB-5339 overview

CB-5339 is under development for the treatment of relapsed or refractory acute myeloid leukemia, relapsed or refractory intermediate or high risk myelodysplastic syndrome, refractory multiple myeloma, relapsed multiple myeloma. The drug candidate is a selective, second generation small molecule valosin-containing protein (VCP)/p97 inhibitor and is administered orally as capsule formulation.

It was under development for lymphomas, and solid tumors.

CASI Pharmaceuticals overview

CASI Pharmaceuticals (CASI) is a biopharmaceutical company, which focuses on the development and commercialization of innovative therapies for treating cancer and other unmet medical needs. The company’s product EVOMELA (melphalan for injection) an intravenous formulation for the treatment of multiple myeloma. It’s pipeline product portfolio includes CID-103 for treatment of multiple myeloma; CNTC 19 for hematological malignancies; ZEVALIN for treatment of relapsed/refractory, low-grade B-cell non-Hodgkin’s lymphoma (NHL); MARQIBO for treatment of Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL); BI-1206 for non-hodgkin’s lymphoma and solid tumors; CB-5339 AML/MDS and solid tumors; Octreotide LAI for treatment of acromegaly and symptoms associated with neuroendocrine tumors. The company operates its subsidiaries in the US and China and a research and development center in Beijing, China. CASI is headquartered in Rockville, Maryland, the US.

For a complete picture of CB-5339’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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.