Investor Presentaiton
IBI-326 (BCMA CAR-T) Development Plan Overview
BCMA CAR-T with Best-in-class Profile Near NDA Stage in China
•
IBI-326 Differentiated Advantages
Improved efficacy likely due to the lower binding affinity of BCMA CAR
(facilitate serial triggering of CAR-T cell) and long-term persistence of CAR-T
cells
Improved persistence likely due to the humanized BCMA CAR (reduced CAR-
directed immune clearance)
• O ICANS
IBI-326 Clinical Highlights
Dose (x10 cells/kg)
01-001
01-002
1.0
1.0
01-004
1.0
01-005
3.0
*
01-007
3.0
70.6% G1-2 CRS
01-009
3.0
01-010
6.0
01-011
01-012
6.0
6.0 H
01-013
01-015
3.0
01-016
01-019
3.0
1.0
01-020
1.0
01-021
1.0
**
01-022
1.0
01-023
1.0
01-024
1.0
Patient number
Response
SCR
CR
VGPR
PR
MR
Stable disease
PD
NA
Death
H
•
Highly effective in pts with prior murine BCMA CAR-T failure
•
Improved safety likely due to the lower peak concentration CAR-T cells
MRD
*Negative
* Positive
0
100
200
300
400
500
600
700
(Blood, 2021, 137: 2890-2901)
Days Postinfusion
IBI-326 Clinical Highlights
In a phase 1 study of IBI-326 in 18 r/r MM:
IBI-326 Development Program Overview
r/r MM:
Have been enrolling patients for the ongoing pivotal phase
study of IBI-326 for r/r MM
Received breakthrough therapy designation from NMPA
Phase 1 study data published in Blood
r/r MM:
2021 plan
Plan to file rolling NDA submission of IBI-326 to the NMPA
for r//r MM in end-2021 to early 2022.
Clinical
100% ORR with 72% CR/SCR
progress
•
1 year PFS rate 58% (while in the first 2 BCMA CAR trials, bb2121 and LCAR-
B38M/JNJ-4528, mPFS <1 year.)
•
CAR-T cell median persistence: 308d (while in the bb2121 and LCAR-B38M/JNJ-
4528, persistence <6mth)
•
3/4 SCR and 4 VGPR in 4 murine BCMA CAR T-exposed pts
(Blood, 2021, 137: 2890-2901).
Near-NDA stage BCMA CAR-T leading development progress in China; best in class potential with impressive preliminary
phase 1/2 data with rapid onset of action and long-lasting efficacy, as well as favorable safety profile.
Innovent
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