Bone marrow aspirate showing acute myeloid leukemia. Credit: VashiDonsk at English Wikipedia/ commons.wikimedia.org.

SELLAS Life Sciences Group has concluded the safety assessment stage of the highest dose cohort of its Phase l dose escalation trial of GFH009 to treat acute myeloid leukemia (AML) patients who relapsed after or were refractory to existing antileukemic therapies.

The company is not planning to conduct any dose escalations in the AML group but will continue to carry out dose escalation in the trial’s lymphoma group by adding a 75mg once-a-week dose cohort.

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During the trial, the AML group received 9mg, 15mg, 22.5mg, 30mg, 40mg, 45mg and 60mg dose levels.  

Patients in this group received 9mg to 40mg two times a week as well as dose levels of 30mg, 45mg and 60mg once a week.

In both the AML and lymphoma groups, anti-tumour activity was reported at different dose levels, including a complete response, partial responses, stable disease, and reduction in tumour burden.

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GFH009, which is a highly selective CDK9 inhibitor, continued to be found safe and well tolerated at all dose levels. No dose limiting toxicities and no important off target toxicities were reported.

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Owing to the robust safety profile, the maximum tolerated dose level was not reached in the trial.

SELLAS president and CEO Angelos Stergiou said: “We believe GFH009 could have the potential to address a major unmet medical need of patients with AML who relapse following treatment.

“We are highly motivated to expedite advancement of GFH009 with our upcoming Phase lla trial, in order to potentially bring this novel treatment to AML patients who need it as quickly as possible.”