On March 25, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, reported that the U.S. Food and Drug Administration (FDA) completed their review of the Company’s Investigational New Drug (IND) submission for CG-806 (Press release, Aptose Biosciences, MAR 25, 2019, View Source [SID1234534580]). Aptose has been granted IND allowance to initiate its Phase 1 clinical trial, which is a Phase 1, multicenter, open label, dose-escalation study with expansions to assess the safety, tolerability, PK, and preliminary efficacy of CG-806 in patients with chronic lymphocytic leukemia (CLL/SLL) or non-Hodgkin lymphomas (NHL).
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Aptose will conduct a Phase 1 trial with orally administered CG-806 in patients with relapsed or refractory B cell malignancies, including CLL/SLL and NHL who have failed or are intolerant to standard therapies. The Phase 1 trial is expected to initiate in the 2nd quarter of 2019. Pending collection and careful review of the initial safety data and predictive pharmacokinetic data in humans from this trial, Aptose plans to seek allowance from the FDA to move into patient populations that include relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in a separate Phase 1 trial.
"We are pleased that the FDA has allowed Aptose to perform clinical trials with CG-806, our first-in-class pan-FLT3/pan-BTK inhibitor," said William Rice, Ph.D., Chairman, President & CEO. "CG-806 has demonstrated a favorable safety profile and compelling durable tumor elimination in animal models of cancer, and we look forward to advancing it into human clinical testing."
About CG-806
CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-cluster kinase inhibitor and is in a Phase 1 clinical trial for hematologic malignancies. This small molecule, in-licensed from CrystalGenomics Inc. in Seoul, South Korea, demonstrates potent inhibition of wild type and all mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), cures animals of acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser (C481S) mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL/SLL, FL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors. Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.