Investor Presentaiton
IBI-375 (FGFR1/2/3) Development Plan Overview
Enzyme Inhibitory Activity of IBI-375
IBI-375 (pemigatinib) Development Program Overview
Parameter
Assay Type
IBI-375
BGJ3981
TAS-120²
ARQ 0873
JNJ-427564934
FGFR1 IC50 (nM)
Enzyme
0.4
0.9
3.9
4.5
1.2
Desired
FGFR2 IC50 (nM)
Enzyme
0.5
1.4.
1.3
1.8
2.5
target activity
FGFR3 IC 50 (nM)
Enzyme
1.2
1
1.6
4.5
3
FGFR4 IC50 (nM)
Enzyme
30
60
8.3
34
5.7
Off-target
activity
VEGFR2 IC50 (nM)
Enzyme
71
180
UNK
21
36.8
H-1581 (FGFR1 amp Lung Ca)
KG-1A (FGFR1 translocated MPN)
Cell viability
14
Cell viability
3
KATO-III (FGFR2 amp Gastric Ca) Cell viability
RT-112 (FGFR3-TACC3 Bladder Ca) Cell viability
3
7
5
Clinical
130
Cellular
potency
200
0.1
progress
UNK
650
1.3
1. Guagnano et al (2011) J. Med. Chem; 2. Babina & Turner (2017), Nature Reviews Cancer; 3. Hall et
al (2016) PLOS ONE 11(9); 4. Lorenzi et al (2017) Molecular Cancer Therapeutics
Fight202 study: IBI-375 in Patients with Previously Treated
Cholangiocarcinoma outside China
.
-
MCCA
Submitted NDA application and accepted in Taiwan
market for IBI-375 for 2L mCCA in 1H 2020
Completed patient enrolment of Phase 2 of IBI-375 for 2L
mCCA in mainland China in 2020
Joined Incyte-sponsored global Phase 3 trial (FIGHT-302)
for IBI-375 for 1L MCCA
Global updates from Incyte
In Mar 2021, PMDA validated Incyte's marketing
authorization application for pemigatinib for mCCA
In Apr 2020, FDA approved pemigatinib for mCCA
OS
Median OS (95% CI), mo
Cohort A
Cohort B
-Cohort C
21.1 (14.8-NE)
6.7 (2.1-10.6)
Expect to receive NDA approval for IBI-375 from Taiwan FDA
for 2L MCCA in 1H 2021
4.0 (2.3-6.5)
2021 plan
•
Plan to file NDA for IBI-375 for 2L mCCA in both mainland
China and Hong Kong around the mid of 2021
1.0
PFS
0.9
1.0
0.9-
0.8
0.8-
0.7
Median PFS (95% CI), mo
0.7-
0.6-
Cohort A
6.9 (6.2-9.6)
0.6-
0.5
Cohort B
2.1 (1.2-4.9)
0.5-
0.4
0.4-
Cohort C
1.7 (1.3-1.8)
0.3
0.3-
0.2
0.2-
0.1
0.1-
0
0
D
2
4
6
8
10
12
14
16
18
20
22
24
0
2
4
6
8
10
12
14
16
18 20 22 24 26
Abou-Alfa GK, et al. Lancet Oncol. 2020 May;21(5):671-684.
IBI-375 exhibits a Best-in-class profile with excellent potency for FGFR 1, 2, and 3.
Fast progressing IBI-375 with pivotal Phase 2 ongoing in China and several more indication development in plan.
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