Blood smear from a person with myelodysplastic syndrome. Credit: The Armed Forces Institute of Pathology (AFIP).

BerGenBio has dosed the first patient in the BGBIL009/BERGAMO Phase II clinical trial of bemcentinib for the treatment of patients with high-risk myelodysplastic syndrome (MDS) who did not responded to first-line of treatment with hypomethylating agents.

Bemcentinib is a selective, potent and orally bioavailable AXL inhibitor.

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The BGBIL009/BERGAMO investigator-sponsored trial is expected to include patients with acute myeloid leukaemia (AML).

The study is designed to determine the efficacy of bemcentinib monotherapy and will include up to 43 patients at eight hospitals in Germany, France, the Netherlands, and Italy.

“AXL represents a promising new target for the patient population investigated in the BERGAMO trial.”

It also aims to assess potential predictive and pharmacodynamic biomarkers for MDS in bone marrow and blood, including patients benefitted from bemcentinib.

The trial’s lead investigator Uwe Platzbecker said: “As treatment of MDS and AML has not changed significantly over the past decades, novel therapies are urgently needed. The survival is still dismal, especially in elderly patients who are not eligible for allogeneic stem cell transplantation and who have failed first-line treatment with hypomethylating agents.

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“AXL, a member of the Tyro3, AXL, Mer (TAM) receptor family, mediates proliferation and survival of leukemic cells and is upregulated upon cytostatic treatment. Pre-clinical studies with the inhibitor bemcentinib demonstrated in vitro and in mouse models that leukaemic proliferation was blocked by interference with AXL signalling.

“Hence, AXL represents a promising new target for the patient population investigated in the BERGAMO trial.”

Germany-based GWT-TUD has sponsored the BGBIL009/BERGAMO with the support of BerGenBio.