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I-Mab Strengthens Givastomig Intellectual Property Portfolio through Acquisition of Bridge Health
GlobeNewswire News Room· 2025-07-17 11:00
Core Viewpoint - I-Mab has announced a definitive agreement to acquire 100% ownership of Bridge Health Biotech Co., Ltd., enhancing its capabilities in developing the bispecific antibody givastomig for cancer treatment [1][2][4] Acquisition Details - The acquisition involves an upfront payment of $1.8 million and non-contingent payments of $1.2 million through 2027, with potential future milestone payments of up to $3.875 million [4] - The transaction is expected to close in Q3 of 2025 [4] Givastomig Development - Givastomig is a bispecific antibody targeting Claudin 18.2-positive tumor cells, currently in development for first-line metastatic gastric cancers, with potential expansion into other solid tumors [5][10] - Recent Phase 1b data showed an 83% objective response rate (ORR) in selected doses for dose expansion cohorts, indicating promising anti-tumor activity [3][6][8] Strategic Importance - The acquisition strengthens I-Mab's intellectual property rights related to givastomig, reduces future milestone payments, and eliminates royalty obligations [2][7] - The CLDN18.2 parental antibody used in givastomig exhibits higher affinity to human CLDN18.2 compared to other antibodies, which may differentiate it as a best-in-class therapy [2][5] Clinical Trial Progress - Enrollment in the first dose expansion cohort has been completed ahead of schedule, with topline results expected in Q1 of 2026 [3][8]
I-Mab Announces Publication of Givastomig Monotherapy Data in Clinical Cancer Research
Globenewswire· 2025-06-30 20:01
Core Insights - I-Mab announced the publication of first-in-human monotherapy data for givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, showing an objective response rate (ORR) of 16% in heavily pretreated Claudin 18.2-positive gastric cancer patients [1][2][4] Summary of Monotherapy Results - The Phase 1 monotherapy study evaluated 75 patients, with 43 being efficacy-evaluable for advanced or metastatic gastroesophageal carcinoma (GEC) [2][5] - The ORR increased to 18% after the enrollment of two additional patients, resulting in 8 out of 45 patients achieving a confirmed partial response (PR) [2][6] - The study demonstrated a disease control rate (DCR) of 49% among the efficacy-evaluable patients [7] Safety and Tolerability - Givastomig was well tolerated, with no dose-limiting toxicity reported up to 15 mg/kg dosed every two weeks and 18 mg/kg dosed every three weeks [15] - The most common treatment-related adverse events were mainly Grade 1 or 2 [15] Development Strategy - The findings support the development of givastomig in combination with standard immunochemotherapy (nivolumab plus mFOLFOX6) as a first-line treatment for gastric cancers [3][4] - An ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment progressing ahead of schedule [10] Unique Mechanism - Givastomig's bispecific design allows for high binding affinity to Claudin 18.2-positive cancer cells, enabling localized T cell stimulation while minimizing gastrointestinal toxicity [4][9]
I-Mab to Host Webinar to Recap New Givastomig Data, in Combination with Immunochemotherapy, Expected at ESMO GI 2025
Globenewswire· 2025-06-18 11:00
Core Viewpoint - I-Mab is hosting a virtual investor event on July 8, 2025, to discuss new data on givastomig, a bispecific antibody targeting Claudin 18.2, following its presentation at ESMO GI 2025 [2][4] Group 1: Event Details - The event will feature Dr. Samuel J. Klempner, who will present new data on givastomig in combination with immunochemotherapy for Claudin 18.2-positive metastatic gastric cancers [3][4] - The data will be presented live at the ESMO GI 2025 on July 2, 2025, with a Mini Oral presentation scheduled for 16:50 CEST (10:50am EDT) [3] - A live Q&A session will follow the formal presentation, and a replay will be available on I-Mab's website for 90 days [4] Group 2: Givastomig Overview - Givastomig (TJ033721 / ABL111) is a bispecific antibody designed to target Claudin 18.2-positive tumor cells, activating T cells through the 4-1BB signaling pathway [6][9] - It is being developed for first-line treatment of metastatic gastric cancers, with potential applications in other solid tumors [6][9] - Phase 1 trials have shown promising anti-tumor activity while minimizing common toxicities associated with other 4-1BB agents [6][9] Group 3: Clinical Study Insights - An ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy for first-line treatment of Claudin 18.2-positive metastatic gastric cancers [7] - The dose escalation phase is complete, and enrollment in the first dose expansion cohort (n=20) has finished ahead of schedule, with continued progress in the second cohort [7] - The study builds on positive Phase 1 monotherapy data, indicating strong potential for further development [7] Group 4: Company Background - I-Mab is a U.S.-based global biotech company focused on precision immuno-oncology agents for cancer treatment, with givastomig as a key product in its pipeline [9] - The company is jointly developing givastomig with ABL Bio, sharing worldwide rights except for Greater China and South Korea [8]
ABL Bio Announces Grabody-B Brain Delivery Platform License Agreement with GSK to Develop Novel Medicines for Neurodegenerative Diseases
Prnewswire· 2025-04-07 00:03
Core Insights - ABL Bio and GSK have entered into a multi-program agreement to develop novel medicines targeting neurodegenerative diseases using ABL Bio's Grabody-B platform technology, which facilitates drug delivery across the blood-brain barrier [1][2][3] - ABL Bio is set to receive up to £77 million in upfront and near-term payments, with potential total payments reaching £2.075 billion across various programs [3] Company Overview - ABL Bio is a clinical-stage biotech company focused on bispecific antibody technology for immuno-oncology and neurodegenerative diseases, with multiple clinical projects underway across different countries [5] - The company is developing several pipelines, including ABL301, ABL001 (tovecimig), ABL111 (givastomig), and others, with ABL001 having received Fast Track designation from the FDA [5] Industry Context - The blood-brain barrier (BBB) presents a significant challenge in developing treatments for neurological diseases, and ABL Bio's Grabody-B technology aims to overcome this limitation by targeting the Insulin-like Growth Factor 1 Receptor (IGF1R) [2] - There is a growing need for new therapeutics for neurodegenerative diseases, driven by an aging population and the increasing prevalence of conditions such as Alzheimer's and Parkinson's [4]