Narazaciclib is under clinical development by Traws Pharma and currently in Phase I for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer). According to GlobalData, Phase I drugs for Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer) have a 90% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Narazaciclib’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.
Narazaciclib overview
ON-123300 is under development for the treatment of solid tumors and hematological tumors including high grade glioma, glioblastoma multiforme, relapsed and refractory multiple myeloma, colorectal cancer, multiple myeloma, mantle cell lymphoma, hepatocellular carcinoma, recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC), HER-2 negative metastatic breast cancer and acute myeloid leukemia (AML). It is a small molecule administered through oral route. It acts by targeting cyclin-dependent kinase 4 (CDK4), cyclin-dependent kinase 6 (CDK6) enzyme, CDK2, FLT3 and ARK5.
The drug candidate was under development for the treatment of triple-negative breast cancer.
Traws Pharma overview
Traws Pharma, formerly known as Onconova Therapeutics, is a clinical-stage biopharmaceutical company. It develops small-molecule oral therapies for respiratory viral diseases and cancer. In the respiratory sector, it is advancing TRX01 (ratutrelvir), targeting SARS-CoV-2 Mpro, and TRX100 (tivoxavir marboxil), effective against drug-resistant influenza strains. In oncology, Traws is developing narazaciclib, a multi-kinase CDK4-plus inhibitor for refractory endometrial and metastatic breast cancer, currently in Phase 1/2 trials and rigosertib for the treatment of epidermolysis bullosa-associated squamous cell carcinoma. The company utilizes a proprietary chemistry platform enhanced by artificial intelligence (AI) and machine learning to optimize compound development and minimize side effects. Traws Pharma is headquartered in Newtown, Pennsylvania, the US.
For a complete picture of Narazaciclib’s drug-specific PTSR and LoA scores, buy the report here.
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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.
