BerGenBio has concluded subject enrolment in a Phase Ib/II BGBC003 clinical trial of bemcentinib in acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) patients.

According to the trial protocol, a total of 86 subjects were enrolled in cohort B, with nearly 14 to 18 subjects in each of the cohorts B1 to B4 and 20 subjects in cohort B5.

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A once-daily oral capsule, bemcentinib is a potent and greatly selective AXL inhibitor.

It attaches to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase, thereby hindering its activity.

The multicentre, open-label Phase Ib/II trial is evaluating bemcentinib as monotherapy and along with cytarabine or decitabine in AML patients or as a single agent in MDS patients.

BerGenBio interim CEO Rune Skeie said: “We are pleased to have completed enrolment of the BGBC003 study and now look forward to delivering our full analysis of the data from this important trial.

“There is a significant unmet need for an effective therapy for relapsed elderly AML patients unfit for intensive chemotherapy, for whom there are currently few treatment options available.”

According to findings from a recent study published in June 2021, bemcentinib plus low dose cytarabine (LDAC) was demonstrated to be effective and well-tolerated in relapsed elderly AML patients who were unfit for rigorous chemotherapy.

Furthermore, the combination provided an overall response rate of 31% and a median overall survival of 13.3 months.

The preliminary survival results showed that the addition of bemcentinib offered more than two times the historic survival rates observed with the standard of care therapies in these patients.

BerGenBio is holding discussions with regulatory authorities in the US and Europe to launch a pivotal registration trial of bemcentinib plus LDAC in relapsed elderly AML patients who are not fit for intensive chemotherapy.

An in-depth translational research programme to detect the predictive molecular, as well as biological factors linked with the response, is currently underway.

In June 2020, BerGenBio started dosing participants in the Phase II ACCORD trial of bemcentinib to treat hospitalised Covid-19 patients.