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Your Position: Home > Licensing > BHE202209

FLT3 Inhibition

BLA Filing
  • Project profile
    Project name: FLT3 Inhibition
    Indications: FLT3-ITD mutation AML
    Research phase: Phase 3, IP in 16 countries
    Cooperation demands: License-out or co-development
  • Highlights

    1. Huge drug market for AML and clear MOA

    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.

    Clear MoA

    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.

    Clear MoA

    (3) Additive effects in the combination of cytarabine or CDK4/6i.

    Clear MoA

    Clear MoA

    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%.

  • Project Introduction

    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.

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