HPB-092 / Polymed Biopharma - LARVOL DELTA

HPB-092 for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Hangzhou Polymed Biopharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2025 ➔ Apr 2026 | Trial primary completion date: Sep 2027 ➔ Jun 2027

Enrollment open • IO biomarker • Trial initiation date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A phase I study of HPB-092, a dual FLT3/IRAK4 inhibitor, in relapsed or refractory acute myeloid leukemia. (ASCO 2026) - P1 | "Site initiation is complete; enrollment is initiated and ongoing, with the first patient anticipated in Q1 2026. Clinical trial registration NCT07137637."

First-in-human • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • FLT3 • IRAK4 • SF3B1 • U2AF1

HPB-092: A novel FLT3 and IRAK4 dual inhibitor for the treatments of AML and MDS (AACR 2025) - "Compared to the approved FLT3 inhibitors gilteritinib and quizartinib, and the clinical-stage FLT3/IRAK4 dual inhibitor CA-4948, HPB-092 showed comparable or superior inhibitory potency against mutated forms of FLT3, improved IRAK4 inhibition, better selectivity, minimal inhibition of CYP3A4, no hERG activity, and an overall favorable safety profile, potentially benefiting a broader range of hematological malignancies. HPB-092 has received FDA clearance for a phase 1 dose-escalation and expansion study to assess its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in adult patients with relapsed or refractory AML, particularly those with FLT3 mutations and U2AF1 or SF3B1 mutations, at a leading cancer center in the US."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • CYP3A4 • FLT3 • IRAK4 • SF3B1 • U2AF1

Development of HPB-092: A novel dual kinase inhibitor targeting FLT3 and IRAK4 for the treatment of relapsed/refractory Acute Myeloid Leukemia (RR-AML) (ASH 2025) - "Compared to the approved FLT3 inhibitors gilteritinib and quizartinib, as well as the clinical-stage dual inhibitor CA-4948, HPB-092 displayed comparable or superior potency against mutant FLT3 and IRAK4, improved kinome selectivity (selectivity score 50 μM), and no hERG inhibition (IC50 > 10 μM), along with an excellent overall safety profile in nonclinical species. The study has been approved by the Institutional Review Board (IRB) and has also been submitted to ClinicalTrials.gov, currently pending final approval. The first patient is anticipated to be enrolled in the fourth quarter of 2025."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • FLT3 • IRAK4 • SF3B1 • U2AF1

HPB-092 for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Hangzhou Polymed Biopharmaceuticals, Inc.

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

China's first FLT3/IRAK4 dual-target inhibitor was approved by the FDA for phase I clinical trial Project Progress [Google translation] (bydrug.pharmcube.com) - "Recently, Hangzhou Duoyu Biotechnology Co., Ltd...has obtained FDA approval for HPB-092, a dual-target FLT3/IRAK4 inhibitor, and will soon start a phase I clinical trial for the treatment of AML."

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

A novel and potent FLT3 and IRAK4 dual inhibitor for the treatment of acute myeloid leukemia (AACR 2023) - "Emavusertib (CA-4948), an IRAK4/FLT3 inhibitor, is currently in phase I clinical trials. In addition, no rhabdomyolysis side-effect was observed upon histological analysis. These results underscore the potential therapeutic benefit and safety profile of HPB-092 for the treatment of AML, especially in patients with mutations in U2AF1 or SFF3B1 spliceosome."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • IRAK4 • NF-κβ • SF3B1 • U2AF1