STI-8591 / Sorrento - LARVOL DELTA

STI-8591, a Novel Tyrosine Kinase Inhibitor, Shows Excellent Antileukemic Activity in FLT3-Mutated (mut) Acute Myeloid Leukemia (AML) (ASH 2023) - "Of note, STI-8591 demonstrates 4-7-fold higher antileukemic activity on otherwise resistant Ba/F3FLT3-ITD(F691L) cells than the currently available FLT3 inhibitors, Gilteritinib and Quizartinib. In conclusion, STI-8591, a novel TKI exhibited a potent antileukemic activity in various FLT3 mut AML models, including those carrying FLT3 mut associated with drug resistance. These results supported further clinical development of STI-8591 for treatment of AML."

Acute Myelogenous Leukemia • Central Nervous System Leukemia • CNS Disorders • Hematological Malignancies • Leukemia • Oncology • FLT3 • PTPRC • STAT5

Rational design of next-generation FLT3 inhibitors in acute myeloid leukemia: From laboratory to clinics. (PubMed, Eur J Med Chem) - "First-generation multi-kinase inhibitors like midostaurin and second-generation agents such as gilteritinib and quizartinib have shown success. It discusses how these agents, including small-molecule like STI-8591, compounds 36 and 80 and novel therapeutic strategies such as CLN-049, and SENTI-202, are designed to combat resistance. The goal is to provide a medicinal chemistry perspective to provide insights for the design of novel small-molecule FLT3i."

Journal • Review • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3

A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Trial completion date: Jul 2025 ➔ Dec 2025 | Trial primary completion date: Jul 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3

A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3

A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd. | Initiation date: Sep 2023 ➔ Mar 2024

Metastases • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3

A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FLT3