Qurient receives Spanish approval for Phase1b study of 실시간-바카라사이트 in chronic GVHD

[by Kang, In Hyo] Qurient, a company specializing in innovative drug development, announced on November 26 that the Phase 1b clinical trial for 실시간-바카라사이트 (development code Q702), an Axl/Mer/CSF1R triple inhibitor candidate for the treatment of chronic graft-versus-host disease (cGvHD), received approval from the Spanish Agency for Medicinal Products and Medical Devices (AEMPS).

This milestone represents 실시간-바카라사이트's first national clinical trial approval in the European Union (EU) following the submission of its Clinical Trial Application (CTA) in July. 실시간-바카라사이트 intends to initiate full-scale patient recruitment and clinical trials in Europe, a region reporting elevated incidence of graft-versus-host disease (GvHD), a trend associated with the well-established registry infrastructure for unrelated hematopoietic stem cell donors.

Chronic graft-versus-host disease (c실시간-바카라사이트) is a clinical sequela that may emerge as a complication in blood cancer patients after undergoing hematopoietic stem cell transplantation. At present, therapeutic intervention is centered on steroids and JAK1 inhibitors. Nevertheless, extended-duration use is limited by long-term treatment-associated adverse effects and the development of drug resistance. Consequently, this condition presents a substantial unmet medical need with no clinically practical alternative identified.

In this context, Niktimvo (axatilimab), a CSF1R-targeting antibody co-developed by Incyte and Syndax as a next-generation treatment, has drawn growing attention as an emerging treatment option. Building on its distinctive mechanistic and development profile relative to Niktimvo, Qurient's 실시간-바카라사이트 seeks to solidify its competitive positioning as a potential best-in-class candidate, leveraging its clear differentiation of the product.

Unlike the antibody treatment Niktimvo, which is administered intravenously (IV), 실시간-바카라사이트 is formulated for oral dosing (by mouth), providing greater convenience for patients needing continuous and repeated administration. Concurrently, as the compound is in development for acute myeloid leukemia (AML) through a mechanism centered on Axl/Mer inhibition, it is expected to yield beneficial outcomes in the management of residual cancer and relapse prevention in cGvHD patients. This development strategy positions it as the first treatment candidate capable of covering the spectrum from primary cancer intervention to the management of post-treatment adverse effects.

"The U.S. Food and Drug Administration (FDA) approval for Niktimvo employed monocyte regulation as a key evaluation indicator, and this effect has already been observed at low doses in cancer patients treated with adrixetinib, which is also under development as an immunotherapy candidate," a Qurient representative said. "Following the U.S., the clinical trial in Europe has received approval as intended, and we plan to accelerate the clinical trial with the goal of verifying efficacy indicators that are directly associated with disease treatment."

Conversely, the cGvHD clinical study evaluating adrixetinib has been in progress since April, following its designation for the ‘National New Drug Development Project Clinical Phase Support Project.’ Qurient plans to accelerate clinical development with research funding from the Korea Drug Development Fund (KDDF).