IMAB
Published on 06/02/2025 at 08:43
June 2025
Advancing givastomig, a novel bispecific, CLDN18.2 x 4-1BB
Clinical data to date has shown anti-tumor activity with limited toxicities
Clinical activity demonstrated across various CLDN18.2 expression levels, with higher binding affinity than other modalities
5-year survival rate of ~7%1
Metastatic gastric cancer impacts over 250k patients globally2
$12Bn addressable market2 in mGC with potential to expand into other tumor types
Phase 1b escalation study of givastomig in combination with nivolumab plus chemotherapy fully
enrolled (n=17); topline data to be presented in oral presentation at ESMO GI 2025
Phase 1b expansion study enrolling ahead of schedule (n=40); topline data expected in 1H 2026
$168.6M of cash as of March 31, 20253; provides runway into 2027, through expected clinical readouts for givastomig
Capital efficient operating model with U.S.-based management team and clinical operations
The American Cancer Society; based on people diagnosed with cancers of the stomach between 2014 and 2020
Markets include U.S., 5 E.U., and Japan in 2025 based on Data Monitor Biomed Tracker; sales estimates based on 2030 data 3
Includes cash and cash equivalents, and short-term investments
Notes: ESMO GI = European Society of Medical Oncology Gastrointestinal Cancers Congress 2025; mGC = metastatic gastric cancer
ASSET PHASE 1 PHASE 2 PHASE 3 INDICATIONS PARTNERSHIPS
Givastomig1
CLDN18.2 X 4-1BB
Bispecific Ab
1L GC, GEJ, EAC: Target
population of ~137k patients2
Ragistomig1
PD-L1 X 4-1BB
Bispecific Ab
Refractory/relapsed cancers: PD-(L)1 progression impacts most patients with metastatic disease
Uliledlimab
CD73 mAb
1L mNSCLC: Target population of 300k+ patients3
TJ Bio
Co-developed with ABL Bio (givastomig also known as ABL111, ragistomig also known as ABL503)
Kohei Shitara, et al, 2023 ASCO Annual Meeting (June 2-6), poster #4035; Markets include U.S., five E.U., and Japan in 2025 based on Data Monitor Biomed Tracker 4
Global Data Epidemiology Data, Guidehouse legacy research
Notes: mNSCLC = metastatic non-small cell lung cancer; PD-(L)1 refers to inhibitors of PD-L1 or PD-1; Ab = antibody; mAb = monoclonal antibody; GC = gastric cancers; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma cancer; 1L = first line; PFS = progression free survival;
5th most common cancer with 250k patients globally and
4th leading cause of cancer mortality worldwide1
Over 60% of patients are diagnosed at an advanced or
metastatic stage2, where prognosis is poor
Current 1L Standards of Care Leave Significant Room for Improvement4
CHECKMATE-649
SPOTLIGHT
47%
37%
40%
40%
mFOLFOX6 or Nivolumab +
CapeOX
mFOLFOX6
or CapeOX
mFOLFOX6 Zolbetuximab
+ mFOLFOX6
ORR - (%)
Despite approved therapies, 5-year survival rates are only ~7%2
Growing market with $12Bn in sales expected by 20303
CHECKMATE-649
SPOTLIGHT
10.6
8.7
6.9
7.7
mFOLFOX6 or Nivolumab +
CapeOX
mFOLFOX6
or CapeOX
mFOLFOX6 Zolbetuximab
+ mFOLFOX6
mPFS - (months)
Sung 2021; Markets include U.S., 5 E.U., and Japan in 2025 based on Data Monitor Biomed Tracker
The American Cancer Society; based on people diagnosed with cancers of the stomach between 2014 and 2020; https://doi.org/10.1016/j.ctarc.2024.100845 5
Markets include U.S., 5 E.U., and Japan in 2030 based on Data Monitor Biomed Tracker
Study results included in FDA approval labels; CHECKMATE-649 used CapeOX in certain patients; comparisons are not based on data from head-to-head trials and are not direct comparisons Notes: ORR = objective response rate; mPFS = median progression free survival; 1L = first line; mFOLFOX6 = standard of care chemotherapy regimen
Disclaimer
I-Mab published this content on June 02, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on June 02, 2025 at 12:42 UTC.