CrystalGenomics said Tuesday that Aptose Bioscience, its U.S. partner, has received approval from the U.S. Food and Drug Administration for its phase 1 clinical trial into CG-806, its leukemia drug candidate.
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 in China in June last year.
The company plans to confirm the safety, tolerability, pharmacokinetics, and pre-efficacy assessment in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and non-Hodgkin lymphoma (NHL) through the clinical trial from the second quarter of this year.
The trial will administer the drug to patients with CLL, SLL, NHL and relapsed or refractory B-cell malignancies, who have either not seen any therapeutic effect or failed in treatment.
Based on the results of the trial, Aptose plans to apply for an additional test for patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
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 are very pleased that FDA has allowed us to conduct clinical trials for CG-806,” Aptose Biosciences CEO William Rice said. “CG-806 has demonstrated excellent anti-cancer effects and safety in animal models of cancer and the company expects to prove excellent results in the human trials.”