Qurient Co. Ltd. has commenced a Phase 1 clinical trial of adrixetinib (Q702) for patients with relapsed or refractory acute myeloid leukemia (AML), following FDA clearance of its investigational new drug (IND) application. The trial (NCT06445907) is designed to assess the safety and preliminary efficacy of adrixetinib as a monotherapy and in combination with venetoclax and azacitidine.
Trial Design and Objectives
The Phase 1 trial is a dose escalation and expansion study. It aims to determine the recommended Phase 2 dose and evaluate the safety profile of adrixetinib, both as a single agent and in combination. The study will also assess preliminary efficacy in patients with relapsed/refractory AML. The trial is being led by Principal Investigator Dr. Abhishek Maiti at The University of Texas MD Anderson Cancer Center.
Adrixetinib: A Novel Kinase Inhibitor
Adrixetinib is an orally bioavailable, selective inhibitor of AXL, MER, and CSF1R kinases. Preclinical studies have demonstrated that adrixetinib exhibits significant anti-tumor activities, enhancing chemo-sensitivity and immune response across various tumor models. The rationale behind the combination therapy lies in the potential synergistic effects of targeting multiple pathways involved in AML progression.
Rationale for Targeting AXL, MER, and CSF1R in AML
The expression of AXL and MER (TAM family kinases) and CSF1R has been correlated with poorer prognosis in AML. These kinases are considered critical therapeutic targets within the cell and tumor microenvironment. Preclinical data indicate that AXL/MER inhibition, both as a standalone treatment and in combination with venetoclax, demonstrates efficacy in various AML models, including aggressive FLT3-ITD bearing AML and venetoclax-resistant primary AML samples. CSF1R inhibition targets AML by disrupting supportive microenvironmental signals, while AXL inhibition in macrophages may enhance the myeloid-centered anti-leukemia immune response.
Qurient's Perspective
"The establishment of adrixetinib’s Phase 2 recommended dosage has set the stage for further clinical collaboration with leading American medical institutions for patients diagnosed with AML, but who may not be eligible for intensive chemotherapy," said Dr. Kiyean Nam, CEO of Qurient. "I believe that adrixetinib’s unique underlying biology can help these patients in combination with venetoclax and azacitidine."
