givastomig (TJ-CD4B) / NovaBridge Biosciences, ABL Bio - LARVOL DELTA

Expanded Safety and Efficacy of Givastomig, a Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in 1L Metastatic Gastroesophageal Carcinoma (mGEC) (ESMO 2026) - No abstract available

Bispecific • Clinical • Combination therapy • Metastases • Gastroesophageal Cancer • Oncology • Solid Tumor • CLDN18

Beyond Zolbetuximab: Next-Generation Targeting Strategies for CLDN18.2. (PubMed, J Gastrointest Cancer) - "Tissue immunohistochemistry remains the reference method for treatment selection; circulating tumor DNA cannot currently reproduce membranous protein intensity or spatial distribution, and liquid-biopsy approaches for CLDN18.2 reassessment remain investigational."

Journal • Review • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hematological Disorders • Oncology • Solid Tumor • CLDN18

First-in-human phase I study of givastomig, a novel Claudin 18.2/4-1BB bispecific antibody in advanced solid tumors (ESMO 2023) - P1 | "The PK profile, s4-1BB induction, and efficacy signal support 12 mg/kg as an optimal dose. Further development of givastomig mono- and combo- therapy in GEC and other cancers is planned."

Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • CLDN18

Updated safety and efficacy from the phase I study of givastomig, a novel claudin 18.2/4-1BB bispecific antibody, in claudin 18.2 positive advanced gastroesophageal carcinoma (GEC) (ESMO 2024) - P1 | "Background: Givastomig/ABL503 (Giva) is a first-in-class, bispecific antibody targeting Claudin (CLDN) 18.2 and engaging 4-1BB through a unique conditional activation mechanism in tumor sites to avoid systemic toxicities. Giva was well tolerated up to 15 mg/kg Q2W and has shown encouraging activity in heavily pre-treated GEC patients with a wide range of CLDN18.2 expression. The current optimal dose range was determined to be 8-12 mg/kg Q2W. A study of Giva in combination with standard of care treatment in 1L metastatic GEC is ongoing."

Clinical • Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Preliminary safety and efficacy of givastomig, a novel claudin 18.2/4-1BB bispecific antibody, in combination with nivolumab and mFOLFOX in metastatic gastroesophageal carcinoma (mGEC) (ESMO-GI 2025) - P1 | "Giva with nivolumab and mFOLFOX was well tolerated up to 12 mg/kg Q2W and shows encouraging preliminary activity in 1L metastatic GEC. Dose expansion is ongoing."

Clinical • Combination therapy • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor • CLDN18

Updated safety, efficacy, and biomarker analysis from the Phase I Study of Givastomig, a novel Claudin 18.2/4-1BB bispecific antibody, in Claudin 18.2 positive advanced gastroesophageal carcinoma (GEC)* (AACR-NCI-EORTC 2025) - P1 | "There is no statistical difference in ORR, DCR, PFS, or OS between CLDN18.2-high pts (n=21) and CLDN18.2-low pts (n=24): ORR 19% vs. 17% (p=1.00), DCR 57% vs. 42% (p=0.46), mPFS 3.68 mo vs. 1.84 mo, PFS hazard ratio (HR) 0.87 (p=0.67), and mOS 7.49 mo vs. 7.49 mo, OS HR 0.88 (p=0.74), respectively.ConclusionsGiva was well tolerated up to 15 mg/kg Q2W and 18 mg/kg Q3W and continues to show encouraging monotherapy activity in heavily pre-treated GEC pts with a wide range of CLDN18.2 expression. Giva may have the ability to target pts with lower CLDN18.2 expression compared with other CLDN18.2 agents and is currently being tested in 1L GEC in combination with immunochemotherapy (NCT04900818)."

Biomarker • Clinical • Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor • CLDN18

Updated Safety, Efficacy and Biomarker Analysis from the Phase I Study of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Claudin 18.2 Positive Advanced Gastroesophageal Carcinoma (GEC) (AACR-NCI-EORTC 2025) - P1 | "There is no statistical difference in ORR, DCR, PFS, or OS between CLDN18.2-high pts (n=21) and CLDN18.2-low pts (n=24): ORR 19% vs. 17% (p=1.00), DCR 57% vs. 42% (p=0.46), mPFS 3.68 mo vs. 1.84 mo, PFS hazard ratio (HR) 0.87 (p=0.67), and mOS 7.49 mo vs. 7.49 mo, OS HR 0.88 (p=0.74), respectively.ConclusionsGiva was well tolerated up to 15 mg/kg Q2W and 18 mg/kg Q3W and continues to show encouraging monotherapy activity in heavily pre-treated GEC pts with a wide range of CLDN18.2 expression. Giva may have the ability to target pts with lower CLDN18.2 expression compared with other CLDN18.2 agents and is currently being tested in 1L GEC in combination with immunochemotherapy (NCT04900818)."

Biomarker • Clinical • Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor • CLDN18

ABL Bio…will unveil at the meeting its bispecific antibody technology that targets cancer cells and immune cells simultaneously. (Chosun Biz) - "The company will share phase 1 data on its bispecific immune-oncology candidates Givastomig and Ragistomigat at the meeting....Designated for priority review (fast track) by the U.S. Food and Drug Administration (FDA), it will skip phase 2 and enter phase 3 in the fourth quarter."

New P3 trial • P1 data • Biliary Tract Cancer • Esophageal Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Pancreatic Ductal Adenocarcinoma

ABL Bio targets December phase 3 start for ABL111 in gastric cancer (Korea Biomedical Review) - "ABL Bio CEO Lee Sang-hoon said Tuesday that the FDA agreed that the phase 1 data were sufficient to support proceeding to the planned pivotal phase 3 trial, although a phase 2 study is already underway...The company expects to obtain major phase 3 data in late 2029 or 2030 if development proceeds as planned."

New P3 trial • P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

NovaBridge Doses First Patient in Global, Randomized Phase 2 Study of Givastomig Combined with Immunochemotherapy in Patients with 1L Metastatic Gastric Cancer (GlobeNewswire) - "The Phase 2 global, randomized study is evaluating the safety and efficacy of givastomig, used in combination with nivolumab and mFOLFOX6, as 1L therapy in patients with CLDN18.2-positive gastric cancer, including gastroesophageal cancer (GEC), gastroesophageal junction cancer (GEJ), gastroesophageal adenocarcinoma (GEA), with CLDN18.2 levels of ≥1+ immunohistochemistry (IHC) intensity on ≥1% of cells, and PD-L1 expression ≥1....Top line results from the Phase 2 study are expected in 2027."

P2 data • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

ABL Bio said it is launching a global Phase 3 clinical trial of its gastric cancer candidate givastomig (ABL111) within this year and plans to start the study in December 2026 (Maeil Business Newpaper) - "The current plan is to start phase 3 global clinical trials of givastomig in December this year."

New P3 trial • Gastric Cancer

NovaBridge Biosciences...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to givastomig in combination with nivolumab and chemotherapy for the treatment of patients with previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinomas (GEA) whose tumors are both Claudin 18.2 (CLDN18.2) and PD-L1 positive. (GlobeNewswire) - "Phase 1b data demonstrated compelling efficacy and tolerability for givastomig in combination with immunochemotherapy, supporting its potential as a premier CLDN18.2-directed therapy for gastric cancer."

Fast track • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A First-in-Human Study of Givastomig, a CLDN18.2 and 4-1BB Bispecific Antibody, as Monotherapy in Patients with CLDN18.2-Positive Advanced or Metastatic Solid Tumors. (PubMed, Clin Cancer Res) - "Givastomig demonstrated manageable safety, dose-proportional exposure, and antitumor activity in patients with advanced solid tumors, particularly in CLDN18.2-positive GEC. A givastomig dose range of 5 to 12 mg/kg was chosen to combine with nivolumab and chemotherapy in part 2 of the study in frontline metastatic GEC."

Journal • Monotherapy • P1 data • Esophageal Cancer • Fatigue • Gastric Cancer • Gastroesophageal Cancer • Hematological Disorders • Oncology • Solid Tumor • CLDN18

Upcoming Givastomig Milestones (GlobeNewswire) - "2026: Medical meeting presentation of Phase 1b combination gastric cancer data; YE 2026: Potential to begin Accelerated Approval Pathway Phase 3 study as early as YE 2026."

New P3 trial • P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

NovaBridge Announces Productive FDA Type B Meeting on Potential Accelerated Approval Pathway for Givastomig in Gastric Cancer (GlobeNewswire) - "FDA confirmed givastomig’s potential eligibility for an accelerated approval pathway. NovaBridge expects to initiate a registrational Phase 3 combination trial as early as Q4 2026, using objective response rate (ORR) as a primary endpoint for accelerated approval....Final study design details will be discussed with FDA."

FDA event • New P3 trial • Gastric Cancer

Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=330 | Recruiting | Sponsor: I-Mab Biopharma US Limited | N=168 ➔ 330 | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Biliary Cancer • Biliary Tract Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CLDN18 • PD-L1

Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2) (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: I-Mab Biopharma US Limited

IO biomarker • New P2 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18 • PD-L1

NovaBridge Presents Positive Givastomig Dose Expansion Data from the Phase 1b Combination Study in Patients with 1L Metastatic Gastric Cancer (GlobeNewswire) - "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 full data are intended to be presented at a medical meeting later in 2026...Only Grade 4 TRAE was neutropenia (4% at 8 mg/kg and 7% at 12 mg/kg); No Grade 5 TRAEs were reported."

P1 data • Gastric Cancer • HER-2

Results from the phase 1 first-in-human clinical trial (NCT04900818) found that givastomig (TJ033721/ABL111) has a manageable safety profile and encouraging antitumor activity in patients with CLDN18.2-positive gastroesophageal carcinoma. (Targeted Oncology) - "Givastomig monotherapy demonstrated encouraging antitumor activity in this heavily pretreated patient population. Among 73 efficacy-evaluable patients, the confirmed objective response rate (ORR) was 11% (95% CI, 4.9%–20.5%), including 8 partial responses (PRs). The disease control rate (DCR) was 37% (95% CI, 26.0%–49.1%), including 27 patients with PRs or stable disease (SD)...In the key cohort of 43 patients with CLDN18.2-positive gastroesophageal carcinoma treated with doses from 5 to 18 mg/kg, the clinical activity was more pronounced."

P1 data • Gastroesophageal Junction Adenocarcinoma

I-Mab To Present Positive Updated Givastomig Monotherapy Data at 2025 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference on October 23, 2025 (GlobeNewswire) - "Updated Phase 1 givastomig monotherapy data show an impressive 18% ORR in metastatic gastric cancer patients who had received at least two prior lines of therapy. Responses were observed over a dose range from 5 mg/kg Q2W up to 18 mg/kg Q3W. No differences in efficacy were observed across different CLDN18.2 expression levels, with favorable overall safety....'In Q1 2026, we expect to report topline results from the fully-enrolled Phase 1b dose expansion immune-chemotherapy combination study and initiate a global, randomized Phase 2 combination study'."

New P2 trial • P1 data • Gastric Cancer

Givastomig, a potential best-in-class Claudin 18.2 X 4-1BB bispecific antibody… (GlobeNewswire) - "A global, randomized Phase 2 study is planned, with the enrollment of the first patient targeted in Q1 2026."

New P2 trial • Gastric Cancer • Gastrointestinal Cancer • Solid Tumor

I-MAB (Nasdaq: IMAB) Transitions to NovaBridge Biosciences (Nasdaq: NBP) with Trading Effective October 30, 2025 New Brand and Logo to Reflect Strategic Transformation to a Global Biotech Platform (GlobeNewswire) - "The change was overwhelmingly approved by shareholders at the Company’s Extraordinary General Meeting held on October 24, 2025, and by the Company’s Board of Directors. The Company’s American Depositary Shares (ADSs) will trade on Nasdaq under the new name and a new ticker symbol, 'NBP', effective at the opening of trading on October 30, 2025....Company core asset, givastomig, a potential best-in-class Claudin 18.2 X 4-1BB bispecific antibody, continues to advance under previously announced investment plans."

Commercial • Solid Tumor

I-Mab…announced that an abstract related to updated data from the Phase 1 study of givastomig as a monotherapy in heavily pre-treated patients with gastroesophageal carcinoma (GEC) has been accepted as a “short-talk” at the AACR-NCI-EORTC conference (GlobeNewswire)

P1 data • Gastroesophageal Cancer

I-Mab Announces Acceleration of Givastomig Investment and Leadership Appointments (GlobeNewswire) - "Phase 1b dose expansion data expected in Q1 2026...The Company intends to initiate a randomized Phase 2 study in 1L metastatic gastric cancers evaluating givastomig in combination with nivolumab and chemotherapy versus nivolumab and chemotherapy alone. Progression free survival (PFS) data are expected in 2027....Initiation of a 1L metastatic GC cohort for patients who do not qualify for checkpoint inhibitors or the existing approved CLDN18.2 1L GC therapy (Double-Low)."

New P2 trial • P2 data • Trial status • Gastric Cancer

Expansion of Givastomig into Gastrointestinal Malignancies Characterized by CLDN18.2 Expression (GlobeNewswire) - "1L Pancreatic Ductal Adenocarcinoma (PDAC): The Company intends to initiate an additional Phase 1b cohort in 1L, CLDN18.2-positive PDAC evaluating givastomig in combination with chemotherapy; 1L Biliary Tract Cancer (BTC): The Company intends to initiate an additional Phase 1b cohort in 1L, CLDN18.2-positive BTC evaluating givastomig in combination with a checkpoint inhibitor and chemotherapy."

New trial • Biliary Tract Cancer • Pancreatic Ductal Adenocarcinoma