CrystalGenomics Presents Interim Results of CG-806 Phase 1 Clinical Trial at American Society of Hematology Meeting

[Asia Economy Reporter Hyunseok Yoo] CrystalGenomics announced that it presented the interim results of the Phase 1 clinical trial of the world’s first (First in class) blood cancer drug candidate ‘CG-806’ at the American Society of Hematology (ASH), held virtually from December 5 to 8.

According to Aptose Bioscience Inc., which is conducting the clinical trial, they presented interim results of the dose-escalation Phase 1a/b clinical trial of the non-dependent mutant BTK/FLT3 inhibitor CG-806 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or non-Hodgkin lymphoma (NHL).

In the clinical trial targeting B-cell malignancies, CG-806 strongly inhibited multiple key tumor targets (including BTK) and pathways that can target lymphocytosis occurring in chronic lymphocytic leukemia (CLL), and tumor size reduction was confirmed in various types of cancers.

In the most recently conducted 750mg cohort, a dose-limiting toxicity (DLT) possibly related to the drug occurred, and although the cohort is currently being expanded, subsequent data analysis suggests that this adverse event is unlikely to be related to CG-806.

So far, good tolerability has been observed, and no toxicity trends that could hinder further dose escalation have been noted.

Additionally, in the acute myeloid leukemia (AML) clinical trial, dosing was initiated at 450mg twice daily, and four patients, including those with FLT3-ITD (mutant) and FLT3-WT (wild-type), were rapidly enrolled.

Notably, in one FLT3-positive patient who had undergone multiple rounds of chemotherapy, anti-leukemic activity was observed, with peripheral blood blast counts (diagnosed as leukemia when above 25%) decreasing from 93% to 10% during the first treatment cycle. Good tolerability was also observed, and no toxicity trends that could hinder further dose escalation were noted.

William G. Rice, CEO of Aptose, stated, “As observed in the development of other successful BTK inhibitors, the on-target lymphocytosis and tumor size reduction observed in CLL patients treated with CG-806 could serve as positive early indicators of the tumor response that will ultimately emerge.”

He also said, “We are pleased with the anti-leukemic activity observed in one AML patient who had been continuously treated with FLT3 inhibitors and the reduction of peripheral blood blast counts from 93% to 10% during the first treatment cycle. We are satisfied with the confirmed activity markers of CG-806 and plan to provide additional updates at the European Hematology Association (EHA) 2021 in the first half of next year.”

Currently, patients with chronic lymphocytic leukemia (CLL) are being enrolled to receive 750mg. If this 750mg dose level is confirmed to be safe, Aptose plans to increase the dose up to the planned maximum dose level of 900mg.

This content was produced with the assistance of AI translation services.