Antengene gets NMPA nod for eltanexor phase 1/2 clinical trial in myelodysplastic syndrome

Antengene has been given approval from China’s National Medical Products Administration (NMPA) for a phase 1/2 clinical trial of ATG-016 (eltanexor) in myelodysplastic syndrome (MDS).

The Chinese biopharma company will enroll patients having intermediate and higher risk myelodysplastic syndrome as determined by the Revised International Prognostic Scoring System (IPSS-R) after the failure of hypomethylating agents (HMA) based therapy.

The single-arm, open-label clinical study in Mainland China aims at assessing the pharmacokinetics, safety and efficacy of ATG-016 as a monotherapy.

Myelodysplastic syndrome is a heterogeneous group of clonal disorders of the bone marrow hematopoietic stem cells (HPSCs). It is characterized by ineffective hematopoiesis with peripheral blood cytopenia and also a higher risk for developing acute myeloid leukemia (AML).

Dr Jay Mei – the Founder, Chairman and CEO of Antengene said: “Elinexor, the first-generation selective inhibitor of nuclear export (SINE), has shown extensive activity against hematological malignancies and solid tumors, and has been approved by the FDA for relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma.

“As a second-generation orally available SINE compound, ATG-016 can reduce the blood-brain barrier penetration, thereby representing a broader therapeutic window with potentially less adverse events and better drug tolerability.”