givastomig (TJ-CD4B) / I-Mab, ABL Bio - LARVOL DELTA

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

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

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

I-Mab Reports Third Quarter 2024 Results (PRNewswire) - "Pipeline Overview and Potential Upcoming Milestones:...(i) The Company is on track to dose the first patient in the randomized Phase 2 study in patients with first-line mNSCLC testing multiple doses of uliledlimab in combination with pembrolizumab plus chemotherapy versus standard of care in 1H 2025...; (ii) Topline data from the on-going Phase 1b study evaluating givastomig in combination with nivolumab plus chemotherapy are expected in 2H 2025 in patients with treatment-naïve CLDN 18.2-positive metastatic gastric cancer."

New P2 trial • P1 data • Gastric Cancer • Non Small Cell Lung Cancer

Optimal dose estimation using an integrated approach from phase I data of givastomig, a novel Claudin18.2×4–1BB bispecific antibody (SITC 2024) - P1 | "- Applicable laws and regulations. The Protocol, Protocol Amendments, ICF, Investigator Brochure, and other relevant documents (e.g., advertisements) were submitted to an IRB by the Investigator and reviewed and approved by the IRB before the study was initiated."

Late-breaking abstract • P1 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • CLDN18 • IL2

Conditional activation of T cell in the tumor microenvironment by a Novel 4-1BB T cell engaging BsAb (Grabody T) and phase 1 trial efficacy and safety of ragistomig (ABL503/TJ-L14B; PD-L1x4-1BB BsAb) and givastomig (ABL111/TJ-CD4B; Claudin18.2x4-1BB BsAb) (AACR-KCA 2024) - No abstract available

Biomarker • Clinical • P1 data • Tumor microenvironment • Oncology • CLDN18

I-Mab to Present Givastomig Phase 1 Optimal Dose Estimation Data at SITC 2024 (PRNewswire) - "I-Mab...announced the presentation of a poster highlighting Phase 1 optimized dose estimation data for givastomig monotherapy (TJ033721/ABL111), a novel first-in-class Claudin18.2 (CLDN18.2) and 4-1BB bispecific antibody, at SITC 2024."

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

ABL Bio, '4-1BB Single Antibody' Patent Decision in the US and Australia [Google translation] (HIT News) - "ABL Bio...announced on the 30th that its patent for the 4-1BB monoclonal antibody and its uses has been granted in the United States and Australia. The patent was applied for internationally in December 2019, and ABL Bio can protect its rights to the 4-1BB monoclonal antibody until 2039...The 4-1BB monoclonal antibody has a mechanism that activates T cells, one of the immune cells, and causes the T cells to attack cancer cells....Representative pipelines to which Grabody-T is applied include ABL503 (Ragistomig), ABL111 (Givastomig), ABL103, and ABL105."

Patent • Oncology • Solid Tumor

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

I-Mab Presents Updated Phase 1 Givastomig Data at ESMO 2024 (PRNewswire) - P1 | N=168 | NCT04900818 | Sponsor: I-Mab Biopharma US Limited | "I-Mab...announced a poster presentation highlighting encouraging top-line results from its ongoing Phase 1 clinical study (NCT04900818) of givastomig...in patients with advanced cancers, especially gastric cancers (including gastroesophageal carcinoma, or GEC) at the European Society for Medical Oncology (ESMO) Congress 2024, taking place in Barcelona, Spain...'we look forward to sharing the results from this study in the second half of 2025.'...Of the 43 patients with CLDN18.2+ GEC who received givastomig monotherapy at doses ranging from 5 to 18 mg/kg, partial responses were observed in seven patients (one at 5 mg/kg, one at 8 mg/kg, four at 12 mg/kg, and one at 18 mg/kg) with an objective response rate (ORR) of 16.3% (7/43 patients) for single agent givastomig....Givastomig exhibited a linear PK at doses ≥5 mg/kg and showed a dose-dependent increase in soluble 4-1BB levels..."

P1 data • PK/PD data • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

I-Mab Reports 1H 2024 Financial Results, Pipeline Progress, and Business Updates (PRNewswire) - "Uliledlimab is also being evaluated in an ongoing, randomized Phase 2 study conducted by I-Mab's collaborator, TJ Biopharma, comparing uliledlimab plus toripalimab to pembrolizumab alone and toripalimab alone. The primary endpoint is progression free survival ('PFS'), and data are expected in the 2H 2025; I-Mab has received IND clearance to proceed with a randomized Phase 2 study testing multiple doses of uliledlimab plus pembrolizumab/chemotherapy vs. pembrolizumab/chemotherapy alone. Patient enrollment is expected to begin in the 1H 2025; R&D costs for the six months ended June 30, 2024 were $1.8 million higher than the comparable period in 2023, driven by higher clinical trial costs associated with the preparation of enrollment for the uliledlimab Phase 2 combination study and ongoing givastomig Phase 1b dose expansion study."

Commercial • IND • New P2 trial • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ABL Bio Completes Third-Party Allocation Paid-in Capital Increase for Development of Next-Generation Dual Antibody ADC [Google translation] (ABL Bio Press Release) - "ABL Bio...announced on the 11th that it has completed payment for a third-party allocation paid-in capital increase worth 140 billion won....Meanwhile, the existing 4-1BB-based dual antibody immunotherapy and blood-brain barrier (BBB) ​​shuttle platform 'Grabody-B' are planned to be developed with the technology fee (milestone) that ABL Bio is scheduled to receive in the future and the contract fee for additional technology transfer. The representative 4-1BB-based dual antibodies ABL503 and ABL111 are currently undergoing clinical phase 1 tumor expansion part and triple combination therapy (ABL111 + nivolumab (Opdivo) + chemotherapy) evaluation clinical trials, respectively. Another 4-1BB dual antibody ABL103's domestic phase 1 clinical trial and ABL105's Korean and Australian phase 1 clinical trials, which were transferred to Yuhan-Yanghaeng and are currently under development, are also progressing smoothly."

Commercial • Oncology • Solid Tumor

I-Mab’s management team undergoes another major reshuffle: only three innovative pipelines remain, and the shadow of CD47 target failure remains [Google translation] (Sina Corp) - "After announcing the divestment of its assets in China, the official website of listed company I-Mab currently only has three innovative pipelines left, namely uliledlimab (CD73 antibody), givastomig (Claudin 18.2 x 4-1BB bispecific antibody) and ragistomig (PD-L1 x 4-1BB bispecific antibody)....I-Mab said it will launch a Phase III clinical trial of uliledlimab combined with chemotherapy and immune checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC) in the second half of 2024."

New P3 trial • Pipeline update • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor