On January 6, 2026 NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, reported positive updated results from the Phase 1b combination study of givastomig, a Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy (mFOLFOX6) in patients with HER2-negative, first line (1L) metastatic gastric cancer.
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The results combine data from patients in the Phase 1b dose escalation and expansion cohorts treated with 8 mg/kg or 12 mg/kg of givastomig. An ORR of 77% (20/26) at the 8 mg/kg dose, and 73% (19/26) at the 12 mg/kg dose, confirms and extends positive signals observed in the dose escalation cohorts. Responses continue to be rapid and deepen over time, and were observed across all levels of CLDN18.2 and PD-L1 expression levels. The safety profile of the combination was similar to earlier observations, except for the emergence of immune-related gastritis, which correlated with improved clinical outcomes. These data, outlined in detail below, position givastomig as a potential best-in-class CLDN18.2-directed therapy for gastric cancer, a potential $12 billion market opportunity by 2030. The full data are intended to be presented at a medical meeting later in 2026.
The Phase 1b study (NCT04900818) is evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig, used in combination with nivolumab and mFOLFOX6, as 1L therapy in patients with CLDN18.2-positive gastric cancer (GC) (≥1+ immunohistochemistry (IHC) intensity in ≥1% of cells), and any level of PD-L1 expression. The primary endpoint is safety. Secondary endpoints include progression free survival (PFS). The study enrolled only patients in the U.S.
"The dose expansion data reinforce the strong signals we observed in dose escalation. The efficacy is clear at 8 mg/kg, with robust ORRs, including in subgroups defined by low PD-L1 and/or CLDN18.2 expression. The PFS data are very promising and continue to mature. Emerging efficacy data at 12 mg/kg are also strong and similar in terms of ORR. The 12 mg/kg cohort was enrolled after the 8 mg/kg cohort, so follow-up is shorter and PFS is less mature. We expect to report these data later in 2026. We remain enthusiastic about the 12 mg/kg dose because exposure analysis shows higher exposure is consistently associated with a higher probability of response, without a higher probability of toxicity," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.
"I continue to be encouraged by givastomig’s high response rate across a wide range of Claudin 18.2 and PD-L1 expression levels, and the depth and duration of responses achieved with combination therapy. The development of gastritis was not predicted by the monotherapy study, and may be related to longer givastomig exposure duration, something that has been seen with some CLDN18.2-directed agents. Most gastritis cases were low grade and manageable, and interestingly appear to be associated with higher response rates and longer survival," said Samuel J. Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. "Givastomig’s favorable benefit-risk balance has the potential to offer real world benefit to patients and is planned to be investigated in a randomized trial."
"Givastomig is a core program for NovaBridge," said Sean Fu, PhD, MBA, Chief Executive Officer of NovaBridge. "The compelling Phase 1b data presented today have the potential to establish givastomig as the leading CLDN18.2-directed therapy for 1L gastric cancer, where the unmet medical need remains high and the commercial opportunity is significant."
Topline Data from the Givastomig Phase 1b Dose Escalation and Expansion Combination Study in 1L Gastric Cancer
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54 advanced metastatic gastric cancer patients (metastatic gastric, esophageal or gastroesophageal adenocarcinomas) were enrolled in cohorts across the 8 mg/kg (n=27), and 12 mg/kg (n=27) dose levels as of the December 2, 2025 data cutoff. 52 patients were efficacy evaluable
•
Demographics show characteristics typical of metastatic gastric cancer in patients
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All patients were HER2-negative, CLDN18.2-positive (defined as ≥1+ IHC staining intensity in ≥1% of tumor cells), regardless of PD-L1 expression levels
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Enrolled at sites only within the United States
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Biomarker expression consistent with prevalence, noting that in efficacy evaluable patients:
o
8 mg/kg cohort was over-represented with tumors expressing CLDN18.2 >75% (63%)
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12 mg/kg cohort was over-represented with tumors expressing PD-L1 <1% (34%)
Efficacy Results: 51/52 patients exhibited a reduction in the volume of target lesions per RECIST v1.1.
Phase 1b Combination Data
Based on patients in the dose escalation and dose expansion cohorts
Dose level
8 mg/kg
12 mg/kg
Enrolled patients
27
27
Efficacy evaluable patients (n)1
26
26
ORR: % (n)
77 (20/26)
73 (19/26)
•
PR2
77 (20/26)
69 (18/26)
•
CR
–
4 (1/26)
•
SD
19 (5/26)
27 (7/26)
•
PD
4 (1/26)
–
DCR3 % (n)
96 (25/26)
100 (26/26)
Median time to onset of response
(months, Min, Max)
1.8 (1.3, 7.5)
2.5 (1.5, 5.4)
Footnotes:
1. Efficacy evaluable patients defined as having had at least one evaluable on-treatment scan
2. The 12 mg/kg cohort includes three patients with unconfirmed partial responses, still on treatment
3. DCR defined as patients with a complete response (CR), partial response (PR) confirmed and unconfirmed, or stable disease (SD)
Biomarker Expression
Phase 1b ORR Combination Data by Status
Based on patients in the dose escalation and dose expansion cohorts
Dose level
8 mg/kg
12 mg/kg
PD-L1 ≥1
74 (17/23)
75 (12/16)
PD-L1 <1
100 (3/3)
70 (7/10)
CLDN18.2 ≥75%
76 (13/17)
67 (8/12)
CLDN18.2 <75 %
78 (7/9)
79 (11/14)
Note: For patients with low PD-L1 and low CLDN18.2 the ORR was 83% (5/6)
Durability of Response Data
Phase 1b PFS Combination Data in Efficacy Evaluable Patients
Based on patients in the dose escalation and dose expansion cohorts
Dose level
8 mg/kg
12 mg/kg
Enrolled patients
27
27
Efficacy evaluable patients (n)
26
271
Median follow-up (month)
10.7
6.8
Events n (%)
12 (46%)
5 (19%)
Censored n (%)
14 (54%)
22 (81%)
Median PFS (mo., 95% CI)
16.9 (6.8, NA)
7.7 (6.9, NA)
6-month PFS rate (95% CI)
73% (51.7, 86.2)
91% (69.0, 97.7)
DOR (month, 95% CI)
15.2 (5.6, NA)
NA
Patients remaining on study
11
18
Footnotes:
1. The 12 mg/kg cohort includes one additional patient for survival analysis who was ineligible for response analysis
Safety: Consistent with previously reported results; incidence of TEAE, TRAE and SAE comparable to 1L combinations in relevant GC benchmark studies (CHECKMATE-649 and SPOTLIGHT), with no dose dependence in TRAE
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Common TRAEs (≥15% of patients in either dose) due to any drug were fatigue, nausea, neutropenia, observed in the majority of patients in each cohort. Grade 3 incidence was low in each cohort (listed as a percentage for 8 mg/kg and 12 mg/kg, respectively): fatigue (7%, 11%), nausea (7%, 4%), and neutropenia (26%, 26%)
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Most common givastomig-related TRAEs (>10% of patients in either dose): nausea, vomiting, and fatigue, all of which had a Grade 3 incidence of ≤11%
•
Immune-related gastritis was observed in 33% of patients in each cohort (Grade 3 in 4% of patients dosed at 8 mg/kg and 15% of patients dosed at 12 mg/kg):
o
Gastritis was not observed in the monotherapy Phase 1 study of givastomig and infrequently observed with nivolumab and chemotherapy
o
Most commonly occurred after several cycles of therapy, was documented via endoscopy, and was managed with medications and treatment interruption
•
Patients developing gastritis were observed to have improved ORR, PFS and OS compared to patients who did not develop gastritis
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Only Grade 4 TRAE was neutropenia (4% at 8 mg/kg and 7% at 12 mg/kg)
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No Grade 5 TRAEs were reported
Business Update with Leerink Partners
Leerink Partners (Leerink) will host a NovaBridge Business Update on Tuesday, January 6, 2026 at 8:30 AM ET. Interested investors should contact their Leerink representative to join.
Business Update with CITIC Securities
CITIC Securities (CITICS) will host a NovaBridge Business Update (in Chinese) on Wednesday, January 7, 2026 at 9:00 AM HKT. Interested investors should contact their CITICS representative to join.
About Givastomig
Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.
Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.
(Press release, NovaBridge Biosciences, JAN 6, 2026, View Source [SID1234661757])