The Best Target & The Best Chemical
PHI-101-AML is a treatment drug for refractory/recurrent acute myelogenous leukemia (AML). It is a ”Best-in-Class” next-generation FLT3 inhibitor with high safety and compared to global competitors and differentiated efficacy against resistance of existing FLT3 inhibitors. Currently, we are conducting phase 1 global clinical trials in Australia and Korea.
FLT3-ITD mutation was found in 25% to 35% of all AML patients
Development of next-generation FLT3 inhibitor capable of treating FLT resistant mutations is required
- Superior efficacy about Drug resistant FLT3 Mutation (D835 or F691)
- Effect of reducing malignant cells in the bone marrow by up to 98% in 1 month in patients who are non-adaptive to competitive drugs
- Selection of candidate by prediction of Chemiverse ADMET (Confirmed by clinical trial results)
- Less adverse events and better hematological recovery compared to competing
- Suppression of malignant prognostic factor (DNMT3A, IDH1, TET2) in AML
- Conditional marketing authorization and US orphan drug designation
Number of patients About 14,000people
Market size KRW 570.4B (2023) Target Market
- FLT3 Mutation positive patients
Sources : DRG, 2019
- FLT3 & Axl double inhibitor, response rate in phase 3 clinical trial was 34%.
- 30.5% recurrence (96% within 4 weeks) in phase 3 clinical trial. Major cause of recurrence is FLT3 F691 resistance mutation.
- Japanese and USA FDA approved only for FLT3-ITD and D835 mutations.
Efficacy in AML patients with
FLT3-ITD. It is very likely to lead
to another adverse effects due to
non-selectivity to kinases
(clinical dose; 40mg).
- Low efficacy in clinical trials when administered alone.
- US FDA approval for combined administration, not a single treatment.
- Efficacy in AML patients with FLT3-ITD. It is very likely to lead to another adverse effects due to non-selectivity to kinases
(Ambit Biosciences)PHASE 3
- Licensing agreement with Astellas after phase 1 clinical trial (390 mUSD).
- Decreased efficacy for AML patients with TKD(D835V,D835Y) and Gatekeeper(F691L) mutations among point mutations other than FLT3-ITD.
- US FDA notified of NDA rejection due to concerns for the data reliability and adverse effects compared to drug efficacy.
(AROG Pharma.)PHASE 3
- As an inhibitor with high selectivity and activity against FLT3, it also shows high activity against D835V, a mutant resistant to quizartinib.
- No activity is reported against the FLT3-ITD F691L mutation.
- Clinical trials are progressing of taking TID.
Animal test results
Excellent life extension
effect in the FLT3-ITD
mutant animal model
Animal test results
compared to competing
drugs in FLT3-ITD/F691L+D835Y
Sample test result
Stronger activity compared to
competitors in AML patient
Toxicity test result
2.5 folds higher tolerability
than competing drugs in GLP