S*BIO Pte Ltd today announced data presentations on its novel oral JAK2 inhibitor, SB1518, at The American Society of Hematology 51st Annual Meeting and Exposition in New Orleans.
Data will be presented on the clinical results from the Phase 1 dose-escalation trial of SB1518 detailing its safety, tolerability and pharmacokinetic/pharmacodynamic (PK/PD) profile in dose levels ranging from 100 to 600 mg. These doses were administered once daily continuously in 28-day cycles in patients with advanced myelofibrosis (MF) and acute myelogenous leukemia (AML). More than 35 patients have been enrolled to date and treated at multiple dose levels ranging from 100-600 mg daily. SB1518 demonstrated promising activity in MF patients. The study generated a positive signal that warrants further investigation.
In an oral presentation, data will be presented from a Phase 1 dose-escalating trial of SB1518 tested in four doses, from 100 to 400 mg per day, in heavily pre-treated relapsed or refractory Hodgkins (HL) and non-Hodgkins lymphoma (NHL) patients. SB1518 was well tolerated with mostly grade 1/2 gastrointestinal side effects. The maximum tolerated dose was not reached in the study and dose escalation is continuing. 15 of 17 treated patients were assessed for tumor response at the eight-week treatment mark. Three patients demonstrated partial and minor responses at the 300 mg dose level and overall 11 patients had stable disease.
"Our clinical findings provide further evidence of SB1518's potential as a viable treatment for myeloproliferative disorders and other hematological malignancies," said Dr. Jan-Anders Karlsson, CEO of S*BIO. "Demonstration of safety, tolerability, and signs of activity in different disease states in our Phase 1 trials, has allowed us to advance SB1518 into Phase 2 clinical trials for further testing of the safety and efficacy of our compound."
Validation of pharmacodynamic (PD) biomarker assays for SB1518 will be presented in a poster, demonstrating PD target efficacy of SB1518 in animal tumor models, as well as, in patients in ongoing Phase 1 clinical studies for advanced leukemias, myeloproliferative diseases and lymphoma. The fourth poster will highlight the effects of SB1518 on ex vivo expanded polycythemia vera (PV) erythroid progenitors which correlate with clinical observations.
SOURCE S*BIO Pte Ltd