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1. Huge drug market for AML and clear MOA
(1) High morbidity and mortality: AML accounts for ~30% of leukemia and ~40% of leukemia-related deaths.
(2) The frequency of FLT3 mutations in AML patients is highest (25–30%). FLT3-ITD is a common mutation (75% FLT3 mutation) and correlates with a poor prognosis and highest risk of relapse found in all AML patients.
(3) FLT3, a RTK, is normally expressed on immature hematopoietic cells and has functions of developing stem cells and immune systems.
(4) The asset is a potent, orally available small molecule TKI against FLT3-ITD and its downstream signal phosphorylation (AKT, ERK, STAT5) to treat AML.
2. A selective inhibition, showing low nanomolar inhibition of FLT3.
3. Excellent anti-tumor effect in vivo.
(1) Asset was able to induce complete regression of tumors at 4.5 mpk QD, with 172% TGI.
(2) Significant efficacy in prolongation of survival in MOLM-13 systemic xenograft model. The ILS of the low dose of this asset is 56%, which is superior to that of the high dose of sorafenib.
(3) Additive effects in the combination of cytarabine or CDK4/6i.
4. Excellent clinical trial date: good safety, well-tolerated, lower dose but better effect.
For R/R AML (≥ 2L) pts with FLT3-ITD mutation in 40 mg dose asset, CRc=57.1%, CR=10.7%.
However, for R/R AML pts with FLT3 mutation in 120 mg dose Gilteritinib, CRc=54.3%, CR=14.2%.
1. Asset type: FLT3 Inhibition
2. Indication: FLT3-ITD mutation AML
3. Research phase: Phase 3, IP in 16 countries
4. Modality: Small molecular
5. Cooperation demands: License-out or co-development
6. Research progress：
(1) Phase 3 trial is ongoing.
(2) Good safety profile, well-tolerated both in preclinical and clinical studies.
(3) Interim results: CRc 57.1% for FLT3-ITD mutation AML.
Explore our catalog of therapeutic antibody solutions to find the right products for you! We are dedicated to delivering solutions designed to help you drive innovation and push the boundaries of what therapeutic antibodies can be.
Organoid Toolbox is a collection of organoid solutions including ready-to-use organoids, organoid differentiation kits, and a variety of services to accelerate the progress of your drug development project.
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