NovaBridge Biosciences · NASDAQ:NBP
NovaBridge Biosciences — I-Mab — ESMO GI 2025
10 slides from NovaBridge Biosciences's conference presentation, Jul 11, 2025
Slide 1: Phase Ib dose escalation study of givastomig with immunochemotherapy in gastric cancer
A Phase Ib dose escalation study of givastomig, a CLDN18.2 x 4-1BB bispecific antibody, in combination with immunochemotherapy in HER2-negative, CLDN18.2-positive gastric, esophageal or gastro-esophageal junction adenocarcinoma Samuel J. Klempner, Farshid Dayyani, Jeremy Kratz, Sunnie Kim, Claire (C
Slide 2: Declaration of Interests
DECLARATION OF INTERESTS SJK has served as a consultant and/or in an advisory role for Bristol-Myers Squibb, Merck, Astellas, Daiichi-Sankyo, Natera, Novartis, AstraZeneca, Mersana, Sanofi-Aventis, Amgen, Boehringer-Ingelheim, Taiho Oncology, Eisai, BeiGene, Elevation Oncology, EsoBiotec, and Gilead
Slide 3: Background
Background Ku ESMO 2024 Shen JITC 2024 Givastomig, a CLDN18.2 x 4-1BB bispecific antibody, was well tolerated as monotherapy and showed activity in heavily pretreated CLDN18.2-positive gastric cancer patients.1 Givastomig exerts anti-tumor activity through CLDN18.2-based, tumor-directed T-cell activ
Slide 4: Phase Ib Study Design of Givastomig Combined with Immunochemotherapy
Notes: GC = gastric cancer; GEJ = gastroesophageal junction; EAC = esophageal adenocarcinoma; mFOLFOX6 = standard of care chemotherapy regimen; Q2W = every two weeks; giva = givastomig; ORR = objective response rate; PK = pharmacokinetic; PD = pharmacodynamic; BoR = best overall response; DoR = dura
Slide 5: Baseline Patient Characteristics
Feature(s) 5 mg/kg (n=5) 8 mg/kg (n=6) 12 mg/kg (n=6) Total (n=17) Age Median (range) 45 54 57 56 (41, 65) (35, 69) (43, 79) (35, 79) Gender Female 3 (60%) 4 (67%) 5 (83%) 12 (71%) Male 2 (40%) 2 (33%) 1 (17%) 5 (29%) Race White 5 (100%) 3 (50%) 3 (50%) 11 (65%) Asian 0 2 (33%) 2 (33%) 4 (23%) Black
Slide 6: Key Adverse Events Related to Any Drug in ≥ 10%
Key Adverse Events Related to Any Drug in ≥ 10% Adverse Event (n=17) Grades ≤ 2 Grade 3 Grade 4 All Grades Neutropenia 6 (35%) 4 (24%) 2 (12%) 12 (71%) Peripheral neuropathy 10 (59%) 0 0 10 (59%) Nausea 9 (53%) 0 0 9 (53%) Vomiting 6 (35%) 0 0 6 (35%) Infusion related reaction 6 (35%) 1 (6%) 0 7 (41
Slide 7: Objective Response Rate of 71% Across Range of PD-L1 & CLDN18.2 Expression
Biomarker Confirmed ORR: % (n) All Escalation (n=17) Cohorts Chosen for Expansion (8 & 12 mg/kg) (n=12) Total 71 (12/17) 83 (10/12) PD-L1 ≥ 5 82 (9/11) 89 (8/9) < 5 50 (3/6) 67 (2/3) ≥ 1 73 (11/15) 82 (9/11) < 1 50 (1/2) 100 (1/1) CLDN18.2 ≥ 75 67 (8/12) 78 (7/9) < 75 80 (4/5) 100 (3/3) Confirmed OR
Slide 8: Responses are Rapid, Deep, and Sustained
8 and 12 mg/kg (n=12) All (n=17) Median follow up (months) (95% CI) 7.8 (5.7, 10.2) 9.0 (6.1, 11.5) Median duration of response (months) (95% CI) NE (4.5, NE) NE (4.8, NE) PFS median (months) (95% CI) NE (4.5, NE) NE (4.8, NE) PFS 6 months (%) (95% CI) 81.5 (43.5, 95.1) 72.9 (42.6, 89.0) Notes: DCO
Slide 9: Conclusions
Givastomig appears to be well tolerated at 5 mg/kg, 8 mg/kg, and 12 mg/kg in combination with nivolumab and FOLFOX, without significant GI, hepatic, or immune-related toxicities. Dose-dependent pharmacokinetics and induction of soluble 4-1BB were observed with the combination, similar to monotherapy
Slide 10: Acknowledgements
I-Mab and the authors would like to thank all the patients and their families, as well as all the investigators, clinical trial researchers, personnel and staff who contributed to or participated in the trial ESMO GI 2025 Copies of this presentation obtained through QR (Quick Response) and/or text k