Mr. Greg Chow reports
APTOSE ANNOUNCES FDA ALLOWANCE OF INVESTIGATIONAL NEW DRUG APPLICATION FOR CG-806
The U.S. Food and Drug Administration (FDA) has completed its review of Aptose Biosciences Inc.'s investigational new drug (IND) submission for CG-806. Aptose has been granted IND allowance to initiate its phase 1 clinical trial, which is a phase 1, multicentre, 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).
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 second 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, PhD, chairman, president and chief executive officer. "CG-806 has demonstrated a favourable safety profile and compelling durable tumour elimination in animal models of cancer, and we look forward to advancing it into human clinical testing."
CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multicluster 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) tumours 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.
About Aptose Biosciences Inc.
Aptose Biosciences is a clinical-stage biotechnology company committed to developing personalized therapies addressing unmet medical needs in oncology, with an initial focus on hematology. The company's small molecule cancer therapeutics pipeline includes products designed to provide single agent efficacy and to enhance the efficacy of other anti-cancer therapies and regimens without overlapping toxicities. APTO-253, the only known clinical stage agent that directly targets the MYC oncogene and inhibits its expression, is in a phase 1b clinical trial for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) or high risk MDS. CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multicluster kinase inhibitor being developed to treat AML and certain B cell malignancies, is in a phase 1 clinical trial for hematologic malignancies.
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