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.
ComboX is a new brand of ACROBiosystems. ComboX products include our Streptavidin series products, coated plates, isotype controls for antibody and fusion protein drug research, and general-purpose antibodies.
Emerging VoCs, Omicron, Delta, Beta, Alpha mutants and so on, including RBD, S trimer, S1, NTD, NP, etc. These mutants are of high purity and bioactivity and can be used to evaluate the efficacy of the antibodies and vaccination.
ACROBiosystems developed a series of GMP grade cytokines under the GMP grade quality management system. Those products are all suitable for T/NK cell generation, activation, and proliferation in cell therapy research.
50+ targets designed for CAR detection, including PE/FITC/biotin labeled proteins. The key reagents for CD19 and BCMA were FDA DMF filed which can support your IND, NDA and BLA process.
GMP grade cytokines, reagents for cell activation, gene edition, DNA/RNA removal, etc. Particularly focus on product design, quality control and solution-based support to link each phase of your cell and gene therapy journey.
Full length multi-pass TPs with stabilized structure and high bioactivity for immunization, antibody screening, cell based assay and CAR detection, including hot CD20, Claudin 18.2， CD133, GPRC5D，CCR8, CCR5, etc.
CD3 proteins and a collection of for bispecific antibody development which are of high specificity and bioactivities and suitable for immunization, antibody screening.
A series of immune checkpoints including classic co-inhibitory and co-stimulatory receptors. The comprehensive catalog contains 100+ targets with various species and tags, and the high-quality proteins are in good batch-to-batch consistency.
To meet the needs of ADCs development, ACROBiosystems can provide: A variety of high-quality target proteins; MMPs/Cathepsin/uPA for cleavable linker; Anti-payload antibodies & anti-idiotypic antibodies for immunogenicity and PK analysis; SPR/BLI analytical and ADA development service.
Comprehensive collection of Fc receptor proteins, including their common variants, which can help expedite your antibody development.
Comprehensive cytokine targets including interleukins, growth factors, chemokines, TNFs, etc. are expressed by HEK293 to ensure their natural structure. Their high purity is verified by SDS-PAGE/HPLC/SEC-MALS and high bioactivity is verified by ELISA/SPR/BLI.
Aneuro is ACROBiosystems brand focused on neuroscience research, providing high-quality important proteins including therapeutic and diagnostic research proteins, PFFs and recombinant neuro factors, etc. to advance neuroscience research.
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