adrixetinib (Q702) / Qurient - LARVOL DELTA

A Study to Evaluate Adrixetinib (Q702) in Adults With Active Chronic Graft-Versus-Host Disease (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Qurient Co., Ltd.

New P1 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Qurient applies for approval of clinical trial plan [Google translation] (HIT News) - "The company announced that it has applied for approval of the 'European Phase 1b clinical trial plan for Q702 monotherapy in patients with chronic graft-versus-host disease' to the European Medicines Agency. This clinical trial is said to establish the recommended Phase 2 dose (RP2D) for Q702 monotherapy for the treatment of patients with chronic graft-versus-host disease. The clinical trial will involve 18 patients and will be conducted at 5 hospitals in Spain."

New P1 trial • Chronic Graft versus Host Disease

Qurient initiates European clinical trial for adrixetinib, accelerating global development of cGvHD [Google translation]. (HIT News) - "Qurient...announced on the 30th that it has submitted a clinical trial application (CTA) and an investigational medicinal product data document (IMPD) to the European Medicines Agency (EMA) to initiate a European clinical trial of adrixetinib (Q702), a candidate for the treatment of chronic graft-versus-host disease (cGvHD)."

New trial • Chronic Graft versus Host Disease

A phase 1b/2, open-label study of selective Axl, Mer and CSF1R inhibitor adrixetinib (Q702) in combination with intravenous pembrolizumab in patients with selected advanced solid tumors: Results of a phase 1 study (QRNT-008). (ASCO 2025) - P1/2 | "Preliminary data from QRNT-008 study showed that selective Axl/Mer/CSF1R inhibitor Q702 plus pembrolizumab has a manageable safety profile. The Part 2 dose of Adrixetinib is confirmed at 120 mg. Preliminary anti-tumor activity in patients previously treated with anti-PD-1 supports further development of the combination."

Clinical • Combination therapy • Metastases • P1/2 data • Cervical Cancer • Dermatology • Gastric Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • AXL

First in human trial of Q702 in patients with advanced solid tumors (AACR 2025) - P1 | "Q702 is a novel Axl/Mer/CSF1R inhibitor with a manageable monotherapy safety profile and pharmacodynamic evidence of Axl and CSF1R inhibition. The neurological events are associated with reversible depletion of microglial cells (Barca et al. 2021), the asymptomatic AST/ALT/CPK increases are felt to be associated with the Kupffer cell reduction."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • AXL

Qurient, 'Adrixetinib' Acute Myeloid Leukemia Clinical Trial First Patient Dosed [Google translation] (HIT News) - "Qurient announced on the 21st that it has started administering the first patient in the clinical trial of 'Adrixetinib (development code name: Q702),' which is being developed as a treatment for acute myeloid leukemia (AML). This clinical trial is being conducted on patients with relapsed or refractory acute myeloid leukemia, and aims to evaluate the safety and efficacy of triple therapy combining adrixetinib with azacitidine and venetoclax."

Trial status • Acute Myelogenous Leukemia

Phase I Study of Q702 with Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2025 ➔ Feb 2025

Enrollment open • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center | Initiation date: Nov 2024 ➔ Nov 2025 | Trial primary completion date: Jul 2026 ➔ Jul 2027

Trial initiation date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Qurient’s Adrixetinib receives FDA IND approval for chronic graft-versus-host disease trial (Korea Biomedical Review) - "Qurient...said Thursday that its immune-oncology drug, Adrixetinib (the generic name and active ingredient of Q702), has received approval from the U.S. Food and Drug Administration (FDA) for a phase 1b investigational new drug (IND) application for chronic graft-versus-host disease (cGVHD)....The clinical trial was approved on Wednesday, less than a month after the submission on Dec 5. The trial will enroll 18 patients at five U.S. hospitals to evaluate the recommended phase 2 dose (RP2D) of Adrixetinib as a monotherapy."

IND • New P1 trial • Chronic Graft versus Host Disease

Phase 1 Study of AXL/MER/CSF1R Inhibitor Q702 with Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia (ASH 2024) - P1 | "Secondary objectives are to study preliminary efficacy of the combination regimen in terms of response rates and survival outcomes. Exploratory objectives include to further study response, survival endpoints and correlative studies to understand mechanisms of response and resistance."

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Hypereosinophilic Syndrome • Leukemia • Myelodysplastic Syndrome • Oncology • AXL • FLT3

Qurient Unveils Clinical Plans for Adrixetinib at ASH Annual Meeting [Google translation] (Business Korea) - "Qurient Therapeutics has unveiled its clinical plans for the immuno-oncology drug Adrixetinib (Q702) at the 66th American Society of Hematology (ASH) 2024 Annual Meeting, held in San Diego, USA, from Dec. 7-10 (local time). The announcement, made in collaboration with the MD Anderson Cancer Center, marks a significant step forward in the treatment of acute myeloid leukemia (AML), a common and challenging blood cancer."

Clinical

Dongkoo Bio acquires exclusive domestic rights to Curient's 'Telacebec' [Google translation] (Biospectator) - "DongKoo Bio announced on the 18th that it signed a letter of intent with Qurient, a new drug development biotech company and its largest shareholder, for the domestic supply, distribution, and sales of 'Telacebec'...According to this letter of intent, Dongkoo Biopharmaceutical will be in charge of domestic distribution and sales of Telacebec. In addition, Dongkoo Biopharmaceutical will be granted priority negotiation rights in the Korean and Southeast Asian markets for the CDK7 inhibitor 'Q901' and the Axl/Mer/CSF1R triple inhibitor 'Q702', which are being developed by Qurient as anticancer drugs."

Commercial • Hematological Malignancies • Infectious Disease • Oncology • Solid Tumor

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients with Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=78 | Active, not recruiting | Sponsor: Qurient Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Oncology • Solid Tumor

Qurient Launches Clinical Trial for Acute Myeloid Leukemia Treatment with Adrixetinib (Q702) (Businesswire) - "Qurient...has announced the commencement of a clinical trial for adrixetinib (formerly named Q702), following the clearance of its investigational new drug (IND) application by the U.S. FDA. The trial is a Phase 1 dose escalation and expansion study designed to assess the safety and preliminary efficacy of Q702 as a single agent and in a triplet combination with venetoclax and azacitidine for patients with relapsed/refractory acute myeloid leukemia (AML)..."

Trial status • Acute Myelogenous Leukemia

Curient stock price is booming... Why have foreigners been buying for 7 consecutive trading days? [Google translation] (Pinpoint News) - "The stock price of Curient, a company specializing in innovative new drug development, is showing an exceptionally strong performance...According to the Korea Exchange on the 12th, as of 9:55 am on the same day, it closed at 3,960 won, up 9.09%...The stock price is trying to break out of the deep bottom and break through the 60-day moving average. Foreigners are on a buying streak for 7 consecutive trading days...Expectations for improved performance appear to be driving up the stock price as the immunotherapy drug adrixetinib (Q702) received IND approval for a clinical trial for acute myeloid leukemia....The anticancer pipeline includes the immunotherapy Q702 and the anticancer drug Q901 targeting cell cycle regulators, and a joint development agreement has been signed with MSD."

Stock price • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Qurient, ‘Axl/Mer/CSF1R’ combination “AML Phase 1/2 approved” [Google translation] (Biospectator) - "Qurient has been evaluated by the U.S. Food and Drug Administration (FDA) for combination therapy with the anticancer drug candidate Axl/Mer/CSF1R triple inhibitor 'adrixetinib (Q702)' for patients with acute myeloid leukemia (AML). On the 19th, researchers announced that they had received approval for an clinical trial protocol (IND) for phase 1/2 clinical trials...'After the recommended dose (RP2D) for the phase 2 clinical trial of adrixetinib was confirmed, joint clinical development with top U.S. medical institutions is continuing to expand indications in earnest.'...The newly approved AML clinical trial is hosted by the MD Anderson cancer center in the United States, and is targeting AML patients with adrixetinib, the chemotherapy drug 'azacitidine', and the Bcl-2 inhibitor 'venetoclax....The efficacy of triple combination therapy will be evaluated."

IND • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Qurient receives clinical approval for ‘Adlixetinib’ for rare blood cancer [Google translation] (HIT News) - "Qurient (CEO Nam Gi-yeon), a company specializing in the development of innovative new drugs, announced on the 14th that the clinical trial plan (IND) for Adrixetinib (development code name Q702) for rare blood cancer has been approved....This clinical trial is a researcher-led clinical trial hosted by Mayo Clinic, the largest general hospital in the United States, and administers adrixetinib to patients with histiocytosis with CSF1R mutation to confirm its efficacy."

New trial • Hematological Malignancies • Oncology

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Qurient Co., Ltd. | Phase classification: P1b/2 ➔ P1/2

Combination therapy • Metastases • Phase classification • Cervical Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor in Patients With Advanced Solid Tumor (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Qurient Co., Ltd. | Trial completion date: Nov 2023 ➔ Feb 2025 | Trial primary completion date: Jul 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A phase 1, multicenter, open-label, dose-escalation, safety, pharmacodynamic, pharmacokinetic study of Q702 with a cohort expansion at the RP2D in patients with advanced solid tumors (SITC 2023) - P1 | "CSF1R inhibition is known to reduce Kupffer cells which are involved in ALT, AST and CK clearance that result in reversible liver enzyme elevations have been reported with other CSF1R targeted antibodies and small molecules. 1 Trial Registration NCT04648254"

Clinical • Metastases • P1 data • PK/PD data • Oncology • Solid Tumor • AXL • CD8 • IFNG

A phase 1B/2, open-label study of Q702 in combination with intravenous pembrolizumab in patients with selected advanced solid tumors (SITC 2023) - P1, P1b/2 | "The secondary endpoints include assessing duration of response (DOR), progression free survival (PFS), overall survival (OS) and additional safety. The study was opened in January 2023 and is currently enrolling patients."

Clinical • Combination therapy • Metastases • P1/2 data • Cervical Cancer • Oncology • Solid Tumor • AXL • CD8

Qurient presents posters of two new anti-cancer drugs at an international academic conference [Google translation] (HIT News) - "Qurient...plans to present the research results of new anti-cancer drugs 'Q901...and 'Adlixetinib' currently under clinical development at the European Society for Oncology (ESMO) and the American Society for Immuno-Oncology (SITC) said on the 23rd. Qurient plans to present a poster introducing the phase 1/2 clinical trial of Q901, a CDK7 inhibitor anti-cancer drug, at the European Society of Oncology (ESMO) to be held in Madrid, Spain in October. The company initially intended to participate in this conference to introduce the clinical design of Q901, which is in the early stages of clinical trials, but since the anticancer efficacy has been confirmed from the lowest dose, the interim results of this clinical trial will be disclosed at an international oncology conference early next year. In November, the American Society of Immuno-Oncology (SITC) will present phase 1 clinical data of the immuno-oncology drug 'Adlixetinib (Q702)'."

Clinical protocol • P1 data • P1/2 data • Oncology • Solid Tumor

Patient pharmacodynamic biomarker and pk evaluation results from an ongoing phase I dose-escalation study of q702, an axl, mer and csf1r kinase inhibitor in patients with advanced solid tumors (AACR 2023) - P1 | "Up to 240 mg, Q702 has demonstrated the intended pharmacologic activity with acceptable safety profile. In biomarker analysis, immune modulation activity is exerted by Axl/Mer/CSF1R inhibition. Further assessment of pharmacokinetics, pharmacodynamics, safety and antitumor activity will be performed at the expansion phase at the RP2D in patients with selected advanced tumors."

Biomarker • Clinical • Metastases • P1 data • PK/PD data • Colon Cancer • Oncology • Pancreatic Cancer • Solid Tumor • AXL • CD8

Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov) - P1b/2 | N=120 | Recruiting | Sponsor: Qurient Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Cervical Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor