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

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

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

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

I-Mab Completes Enrollment in Planned Phase 1b Dose Expansion Study for Givastomig in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers (GlobeNewswire) - "The Phase 1b study (NCT04900818) is evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig, a potential best-in-class, Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, used in combination with nivolumab and mFOLFOX6....Topline results expected in Q1 2026."

P1 data • Trial status • Gastric Cancer

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

Everest Medicines Expands Strategic Investment in I-MAB (PRNewswire) - "Everest Medicines...announced that it has made a strategic equity investment in I-Mab, ('I-Mab')....I-Mab today announced an underwritten offering of 33,333,334 American Depositary Shares (the 'ADSs') representing 76,666,668 ordinary shares at an offering price of $1.95 per ADS, for total gross proceeds of approximately US$65 million. Under the arrangement of this offering, Everest will subscribe for 15,846,154 ADSs (the 'Subscription'), with an aggregate consideration of US$30.9 million....There are three pipeline products of I-Mab in clinical stage, Givastomig (Claudin 18.2 x 4-1BB bispecific antibody), Ragistomig (PD-L1 x 4-1BB bispecific antibody) and Uliledlimab (CD73 antibody)."

Financing • Oncology

I-Mab Strengthens Givastomig Intellectual Property Portfolio through Acquisition of Bridge Health (GlobeNewswire) - "I-Mab...announced that it entered into a definitive agreement to acquire 100% ownership of Bridge Health Biotech Co., Ltd. (Bridge Health). The transaction provides I-Mab with the rights to bispecific and multi-specific applications (including bispecific and multi-specific antibodies and antibody drug conjugates (ADCs)), based on the Claudin 18.2 (CLDN18.2) parental antibody used in the Company’s CLDN18.2 x 4-1BB bispecific antibody, givastomig....I-Mab expects to present topline results from the Phase 1b dose expansion combination study in Q1 of 2026....Under the terms of the agreement, I-Mab will pay Bridge Health shareholders an upfront payment of $1.8 million and non-contingent payments of $1.2 million through 2027. In addition, Bridge Health shareholders may receive future milestone payments of up to $3.875 million, subject to the achievement of certain development and regulatory milestones. The transaction is expected to close in Q3 of 2025."

M&A • P1 data • Esophageal Cancer • 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

I-Mab Announces Publication of Givastomig Monotherapy Data in Clinical Cancer Research (GlobeNewswire) - P1 | N=168 | NCT04900818 | Sponsor: I-Mab Biopharma US Limited | "I-Mab...announced publication of the first-in-human monotherapy data for givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, in Clinical Cancer Research....The study evaluated a total of 75 patients with gastric cancers or other solid tumors, including 43 efficacy-evaluable patients with CLDN18.2-positive advanced or metastatic gastroesophageal carcinoma (GEC)....After the data cutoff, two additional patients were enrolled in the monotherapy study, resulting in an additional confirmed partial response (PR), leading to an increased ORR of 18% (8/45 patients). The Company anticipates sharing an updated monotherapy data set on the 45 patients in the fourth quarter of 2025 at a major medical meeting....Data from the ongoing dose escalation combination study will be presented at a Mini Oral presentation at the ESMO Gastrointestinal (ESMO GI) Cancers Congress 2025 on July 2, 2025 in Barcelona, Spain."

P1 data • Gastric Cancer • Gastroesophageal Cancer

I-Mab Highlights Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025 (GlobeNewswire) - P1 | N=168 | NCT04900818 | Sponsor: I-Mab Biopharma US Limited | "I-Mab...announced publication of ESMO Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) abstract #388MO related to positive data from a Phase 1b study evaluating givastomig in combination with nivolumab and mFOLFOX6 chemotherapy for metastatic gastric cancers. An objective response rate (ORR) of 71% (12/17) was observed across all dose levels with an ORR of 83% (10/12) observed at dose levels selected for the ongoing dose expansion study (8 and 12 mg/kg). Responses were rapid and deepened over time, and were observed in tumors with low levels of PD-L1 expression and/or low levels of Claudin 18.2 (CLDN18.2) expression. There was a favorable safety profile, with low incidence of GI and liver toxicities. I-Mab intends to host a virtual investor event on Tuesday, July 8th...to recap the data being presented at ESMO GI."

P1 data • Gastric Cancer

ABL Bio’s partner to unveil ABL111 combo therapy’s phase 1 results in Europe (Korea Biomedical Review) - "ABL Bio said Tuesday that its partner I-Mab will present data from the phase 1b study of ABL111 (trademark name: Givastomig) combination therapy in a mini oral presentation at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI)....The oral presentation on ABL111 at ESMO GI 2025 is entitled '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)),' which will feature the Dose Escalation Part of the phase 1b study....The Dose Escalation Part is now closed, enrollment in the first Dose Expansion Part is complete, and patient enrollment in the second Dose Expansion Part is ongoing. Data from the Dose Expansion Part will be available in the first half of next year."

P1 data • Trial status • Gastroesophageal Cancer

I-Mab to Host Webinar to Recap New Givastomig Data, in Combination with Immunochemotherapy, Expected at ESMO GI 2025 (GlobeNewswire) - "I-Mab...announced that it will host a webinar to recap new givastomig data being presented at ESMO GI 2025, with a key opinion leader (KOL), on Tuesday, July 8, 2025 at 2:00pm EDT....The data will be presented live at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI 2025) in a Mini Oral presentation on Wednesday, July 2, 2025, at 16:50 CEST (10:50am EDT). This event will spotlight the first presentation of Phase 1b safety and efficacy results from the dose escalation study (n=17) evaluating givastomig in combination with nivolumab and chemotherapy for the first line treatment of Claudin 18.2-positive, metastatic gastric cancers."

P1 data • Gastric Cancer

I-Mab Reports First Quarter 2025 Financial Results and Provides Business Update (I-Mab Biopharma) - "Presentation of new givastomig dose escalation combination data on U.S. patients at the European Society of Medical Oncology ('ESMO') Gastrointestinal ('GI') Cancers Congress 2025, being held July 2-5 in Barcelona, Spain; 1H 2026: Presentation of data from givastomig dose expansion cohorts (n=40); Enrollment in the ongoing dose expansion study for givastomig is progressing ahead of schedule. In addition, the Company anticipates updates in 2026 for two programs being developed with its partners: uliledlimab (monoclonal antibody targeting CD73); and ragistomig (PD-L1 x 4-1BB bispecific)...As of March 31, 2025, the Company had cash and cash equivalents, and short-term investments of $168.6 million. The Company’s current cash position is expected to fund the givastomig Phase 1b study through anticipated dose expansion data readouts and further development initiatives into 2027."

Clinical • Commercial • Enrollment status • P1 data • Gastroesophageal Cancer

I-Mab Announces Givastomig Abstract Accepted for Oral Presentation at ESMO GI 2025 (GlobeNewswire) - "I-Mab...announced that an abstract for a combination study of givastomig plus nivolumab and chemotherapy has been accepted for a mini-oral presentation at the ESMO Gastrointestinal Cancers Congress 2025, which will be held July 2-5 in Barcelona, Spain."

P1 data • Esophageal Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

I-Mab Reports Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Upcoming Phase 1b Givastomig Milestones: (i) 2H 2025: Phase 1b dose escalation data (n=17) expected to be presented at a medical meeting; (ii) 1H 2026: Expected topline results from the ongoing dose expansion study (n=40)."

P1 data • Solid Tumor

I-Mab Announces Accelerated Givastomig Phase 1b Study Progress (GlobeNewswire) - "I-Mab...announced that enrollment has been completed ahead of schedule in the first dose expansion cohort in the Phase 1b givastomig combination study, with continued momentum in the second dose expansion cohort. The Phase 1b study is evaluating givastomig, a potential best-in-class, Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, targeting CLDN18.2-expressing tumor cells for the treatment of gastric cancer in the first-line (1L) setting....Topline results from the 40-patient dose expansion study expected in 1H 2026; Phase 1b dose escalation data expected to be presented in 2H 2025."

P1 data • Trial status • Gastric Cancer

Study of TJ033721 (givastomig) in Subjects with Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=168 | Recruiting | Sponsor: I-Mab Biopharma US Limited | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor • CLDN18 • PD-L1

I-Mab Announces Portfolio Prioritization of Givastomig (CLDN18.2 x 4-1BB Bispecific Antibody) as Lead Clinical Program (PRNewswire) - "The development of uliledlimab is being paused to allow the Company to focus resources toward advancing its lead clinical program, givastomig, and to allow data to mature from an ongoing China-only randomized study conducted by its partner TJ Biopharma evaluating uliledlimab in combination with a CPI (toripalimab) in CD73-high NSCLC patients. As a result, further clinical investment in uliledlimab will be put on hold....Ragistomig: ABL Bio is continuing the Phase 1b study to increase the therapeutic index by altering the dosing level and/or frequency, and to identify the appropriate tumor types for further development....The Company has completed enrollment of a dose escalation study of givastomig in combination with nivolumab plus chemotherapy, and data is expected in the early second half of 2025; a 40-patient dose expansion study is now underway with data expected in early 2026."

Discontinued • P1 data • Pipeline update • Esophageal Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Non Small Cell Lung Cancer • Solid Tumor

ABL Bio-Imapp, ABL111 Poster Presentation at the American Society of Immuno-Oncology [Google translation] (Nate) - P1b | N=168 | NCT04900818 | Sponsor: I-Mab Biopharma US Limited | "ABL Bio announced on the 12th that it had disclosed the clinical phase 1 pharmacokinetic (PK) modeling data of the dual antibody 'ABL111/Givastomic' at the 39th Society for Immunotherapy of Cancer (SITC 2024)....The poster presented at this conference included an analysis of clinical and nonclinical data to determine the optimal dose....According to the analysis results, the dose-response relationship of ABL111/Givastomic was proven, and the optimal dose range was 8-12 mg/kg Q2W (administration at 2-week intervals)....The top-line data of the dose-escalation part of the phase 1b clinical trial for the ABL111/Givastomic triple combination therapy is expected to be announced in the second half of 2025."

P1 data • PK/PD data • Preclinical • Gastric Cancer