Qurient Receives Approval for Clinical Trial Plan of Chronic Graft-versus-Host Disease in Spain

Innovative new drug developer Qurient announced on November 26 that its clinical trial plan for the Axl/Mer/CSF1R triple inhibitor Adricetitinib (Q702) has been approved by the Spanish Agency of Medicines and Medical Devices (AEMPS).

This marks the first clinical trial plan approval Qurient has received from a European country since submitting its Clinical Trial Application (CTA) in July. Qurient plans to begin full-scale patient recruitment and conduct clinical trials in Europe, where the incidence of Graft-versus-Host Disease (GvHD) is high due to the advanced unrelated hematopoietic stem cell donor registration system.

Chronic Graft-versus-Host Disease is a complication that occurs after hematopoietic stem cell transplantation in blood cancer patients. Currently, steroids or JAK1 inhibitors are used for treatment, but there are no suitable alternatives due to side effects and resistance problems associated with long-term administration.

The CSF1R antibody Niktimvo (Axatilimab), jointly developed as a next-generation therapy by Incyte and Syndax, is gaining attention as the next alternative. Qurient expects that Adricetitinib, with its clear differentiation from Niktimvo, will establish itself as a best-in-class new drug within its category.

While Niktimvo, an antibody therapy, is administered intravenously, Adricetitinib is an oral formulation, offering much greater convenience for patients who require continuous dosing. At the same time, based on its Axl/Mer inhibition mechanism, it is also being developed as a treatment for acute myeloid leukemia (AML), and is expected to have a positive effect on the treatment of residual cancer and prevention of recurrence in chronic GvHD patients. It is anticipated to become the first therapy capable of addressing both primary cancer treatment and the management of post-treatment side effects.

The clinical trial of Adricetitinib for chronic GvHD was selected as a national new drug development project clinical stage support task in April this year. Qurient is accelerating clinical development with research funding from the National New Drug Development Project Group, led by Park Youngmin.

A Qurient official stated, "For Niktimvo's FDA approval, the efficacy in regulating blood monocytes was used as an evaluation indicator," and added, "In cancer patients administered Adricetitinib, which is also being developed as an immuno-oncology drug, efficacy has already been observed even at low doses."

The official continued, "With clinical trial approval now granted in Europe following the United States as planned, we will accelerate the trials and quickly validate efficacy indicators directly linked to disease treatment."