Investor Presentaiton
IBI-344 (Taletrectinib, ROS1/NTRK) Development Plan Overview
Leading next-generation ROS1/NTRK at Pivotal Phase 2
IBI-344 (Taletrectinib) Differentiated Advantages
Kinase selectivity
(1) Ba/F3 CD74-ROS1 WT
(2) Ba/F3 CD74-ROS1 G2032R
Preliminary Data of Pivotal Phase 2 (2021 ASCO)
Crizotinib naïve pts: ORR-93% (14/15)
Crizotinib pre-treated pts: ORR=60% (3/5)
100
80
60
40
20
0
•
Taletrectinib Plasma
Concentration (ng/mL)
500
ACK
ALK
ROS1
LTK
DDR1
NTRK1
INTRK2
NTRK3
TXK
『
Tumor Volume (mm³)
300
250
Vehicle
Lorlatinib 2.5 mg/kg
DS-6051b 50 mg/kg
Entrectinib 30 mg/kg
200
150
100
50
0
°
1
2
3
Days after treatment
Tumor Volume (mm³)
500
400
300
200
100
0
2
6
Days after treatment
--Vehicle
DS-6051b 100 mg/kg
Lorlatinib 10 mg/kg
-Lorlatinib 7.5 mg/kg
-Lorlatinib 5 mg/kg
Entrectinib 60 mg/kg)
IBI-344 (Taletrectinib) is highly effective against both ROS1 WT and ROS1 G2032R Mutation with the
potential for a differentiated and competitive clinical profile
Pre-clinical and Clinical Highlights
400
Day 15
300
200
100
0
0
8
12
C101 400mg QD (-3)
-C101 600mg QD (N-7)
Day 1
--C1D1S 400mg QD (N-3)
16
20
24
Time Post Dose (hour)
Brain/plasma ration in preclinical study
Time points (h)
-C1015 600mg QD (N-5)
Pre-treatment
Brain metastases
63012 mutation
SD
SD
PR
PR
PR
Subjects (N-5)
-100
Time gest dose (Months)
2012ation
IBI344 has also shown a manageable safety profile characterized primarily by gastrointestinal adverse
events, with reversible increases AST and ALT.
IBI-344 Development Program Overview
Post-treatment
6 weeks (PR)
Clinical
•
progress
Entered into incense agreement with Anheart to co-develop and co-
commercialize IBI-344 (taletrectinib) in Greater China
ROS1+ NSCLC:
Initial pivotal phase 2 data for ROS+ NSLCC published in 2021
ASCO
NTRK+ solid tumor
Dosed first patient for pivotal phase 2 for NTRK+ solid tumor
4
10
24
Taletrectinib
Repotrectinib
ROS1+ NSCLC:
0.40±0.10
0.90±0.19
0.07±0.01
0.53±0.15
2021 plan
3.111.20
0
IBI-344 has better brain penetration and CNS
tissue durability.
Plan to complete patient enrolment for the pivotal phase 2
for ROS1+ NSCLC
Pivotal-stage potential first-in-class and best-in-class next-generation ROS1/NTRK inhibitor in China with promising preliminary Phase 2
efficacy and safety profile, to address the clear unmet medical needs in ROS1+ NSCLC patient population and NTRK solid tumors.
Innovent
Confidential
Copyright©2021 Innovent Biologics
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