Aptose Announces FDA Allowance of IND for Phase 1a/b Study

Aptose Biosciences Inc. recently announced the US FDA completed its review of the company’s Investigational New Drug (IND) application and has granted IND allowance for the initiation of a Phase 1a/b clinical study of CG-806, the company’s highly potent, oral FLT3/BTK inhibitor, in patients with acute myeloid leukemia (AML). CG-806 is currently in a Phase 1 dose-escalation study in patients with B-cell malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphomas (NHL), who have failed or are intolerant to current therapies.

“Our strategy was to identify a starting dose of CG-806 that we believe could be therapeutically active in critically ill patients with relapsed or refractory AML. We are pleased that the FDA has allowed us to initiate a clinical trial in these patients at a starting dose of 450 mg BID. Despite recent advances in the treatment of AML, many patients relapse or remain refractory to current therapies leading to a poor overall prognosis,” said Rafael Bejar, MD, PhD, Senior Vice President and Chief Medical Officer. “Based on strong preclinical evidence of CG-806’s activity against AML – including demonstration of mutation-agnostic and genotype-agnostic potency, particularly compared against other FLT3 inhibitors, and its ability to safely cure AML in murine leukemia models  –  we believe CG-806 offers hope to the fragile and difficult-to-treat AML patient population. We continue to dose escalate in an ongoing study in patients with CLL and other B cell cancers, and are eager to advance this separate AML protocol through Institutional Review Boards at key clinical sites, recruit appropriate AML patients, and initiate dosing as soon as possible.”

Aptose intends to initiate the Phase 1 a/b study in the second half of 2020 in AML patients who have relapsed, are resistant or refractory to current treatment.