Antengene has plans to assess an Exportin 1 (XPO1) inhibitor, selinexor, in a Phase II clinical trial for the treatment of myelofibrosis (MF) patients in China.
China’s National Medical Products Administration (NMPA) has accepted the company’s investigational new drug (IND) application to conduct the trial.
Karyopharm Therapeutics discovered and developed selinexor, which is an oral selective inhibitor of nuclear export (SINE) compound and marketed as Xpovio in the US.
Under an exclusive development and marketing deal for some Asia-Pacific markets and the Asean countries, Antengene is presently developing the SINE compound.
The randomised, open-label, multi-centre Phase II trial will compare the safety and efficacy of selinexor to physician’s choice (PC) in MF subjects who received a minimum of six months of treatment with a Janus kinase 1/2 inhibitor.
It will enrol a total of about 112 subjects at 75 trial sites globally. Participants will be categorised in a 1:1 ratio to receive either selinexor or PC treatment.
Antengene founder, chairman and CEO Dr Jay Mei said: “This acceptance by the NMPA of the IND application for the China study of selinexor in patients with MF marks another major step forward in our effort to develop selinexor into a novel cancer drug.
“It also paves the way for our ongoing exploration of additional indications for Antengene’s novel assets.”
MF is a clonal hematologic neoplasm that can occur as primary MF, polycythemia vera or essential thrombocythemia.
Currently, the company is carrying out five late-stage trials of selinexor to treat multiple myeloma, diffuse large B-cell lymphoma, non-small cell lung cancer and peripheral T and NK/T-cell lymphoma.
The SINE compound received priority review designation from the NMPA, as well as orphan drug status from the Ministry of Food and Drug Safety of South Korea.
Earlier this year, selinexor (Nexpovio) obtained conditional marketing authorisation from the European Commission to treat relapsed/refractory multiple myeloma in adults.
Antengene dosed the first subject in a Phase I/II HATCH trial of eltanexor (ATG-016) for treating patients with intermediate and higher-risk myelodysplastic syndrome in China in May 2021.