CrystalGenomics said Tuesday that Aptose Bioscience, its U.S. partner, has filed an investigational new drug application for CG-806, its leukemia drug candidate, to the Food and Drug Administration.
CG-806 is a targeted therapy that inhibits Bruton tyrosine kinase (BTK), FMS-like tyrosine kinase 3 (FLT3), and aurora kinase (AURK).
CrystalGenomics licensed out CG-806’s global sales rights, except for Korea and China, to Aptose Biosciences for 360 billion won ($319.1 million) in June 2016. The company additionally gave the exclusive rights for 134 billion won to develop and commercialize the drug within China in June last year.
If approved, Aptose will initiate two phase 1 clinical trials in the U.S.
The company will conduct its first trial in patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome, and, in the second trial, will administer the drug to patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma, non-Hodgkin lymphoma patients and relapsed or refractory B-cell malignancies, who have either not seen any therapeutic effect or failed in treatment.
The main objectives of the two clinical trials are to confirm the safety, tolerability and pharmacokinetic of CG-806.
The two companies expect CG-806 will become an innovative treatment for AML and CLL, which are representative incurable hematological malignancies, as the drug has shown positive results in the preclinical trials.
The treatment can also receive various benefits such as quick examination, conditional approval after clinical phase 2 trial, and monopoly sale for seven years as it received Orphan Drug Designation from the FDA.
“We have already confirmed the possibility of CG-806 as a treatment for blood cancer as the company confirmed through preclinical trials that CG-806 inhibits all forms of FLT3 and BTK, and its mutants, which are targets of blood cancer, while having strong anticancer activity and low toxicity,” Aptose Biosciences CEO William Rice said.
The company hopes that CG-806 will be able to become a new treatment for patients with various blood cancers, especially those who cannot be treated with other BTK or FLT3 inhibitors, Rice added.
<© Korea Biomedical Review, All rights reserved.>