Acquisition provides I-Mab with upstream rights to CLDN18.2 parental antibody for use in bispecific and multi-specific applications Acquisition eliminates all royalty obligations and reduces future milestones for givastomig due to Bridge Health by I-Mab ROCKVILLE, Md., July 17, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced that it entered into a def ...

Company Overview - I-Mab is a U.S.-based global biotech company focused on developing precision immuno-oncology agents for cancer treatment [2] - The company's leading pipeline product is givastomig, a bispecific antibody targeting Claudin 18.2, designed for treating Claudin 18.2-positive gastric cancers [2] - Givastomig activates T cells through the 4-1BB signaling pathway in the tumor microenvironment, showing strong tumor-binding and anti-tumor activity in Phase 1 trials [2] Upcoming Events - I-Mab's management will participate in the BTIG Virtual Biotechnology Conference on July 29-30, 2025 [1] - The conference will include a fireside chat and one-on-one meetings, starting at 10:00 AM ET on July 29, 2025 [1] - A webcast of the event will be available on the I-Mab website for 90 days following the conference [1]

Core Insights - I-Mab announced positive Phase 1b combination data for givastomig, showing a confirmed objective response rate (ORR) of 83% at selected doses for ongoing expansion studies [1][2][3] - The study demonstrated favorable tolerability and safety profile, with no Grade 3 or greater events for nausea and vomiting [2][21] - Givastomig is a bispecific antibody targeting Claudin 18.2 and 4-1BB, being developed for first-line treatment of Claudin 18.2-positive gastric cancers [15][18] Study Results - The Phase 1b study showed an overall ORR of 71% across all doses and 83% at doses selected for expansion (8 mg/kg and 12 mg/kg) [2][10] - Responses were observed in tumors with low PD-L1 and/or Claudin 18.2 expression, indicating broad potential for the therapy [2][3] - The disease control rate (DCR) was 100% across all dose levels, with a median follow-up of 9.0 months [12][13] Safety Profile - Treatment-related adverse events (TRAEs) leading to discontinuation were 12%, with common TRAEs being Grade 1 or 2 [21] - No dose-limiting toxicities (DLT) were observed, and a maximum tolerated dose (MTD) was not reached [21] - Grade 3 TRAEs were rare, with only isolated cases reported [21] Future Plans - I-Mab plans to host a virtual investor event on July 8 to discuss the Phase 1b data further [1][4] - The ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment progressing ahead of schedule [16][18]

Core Insights - I-Mab announced positive data from a Phase 1b study of givastomig in combination with nivolumab and mFOLFOX6 for metastatic gastric cancers, showing an objective response rate (ORR) of 71% across all dose levels and 83% in the selected dose expansion cohort [1][2][3] Study Details - The Phase 1b study evaluated the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig as first-line therapy in Claudin 18.2-positive gastric cancers, with a primary endpoint focused on safety [2][18] - The study enrolled 17 treatment-naïve patients with advanced metastatic gastric, esophageal, or gastroesophageal adenocarcinomas [6][18] Efficacy Results - Overall, 71% (12/17) of patients achieved a partial response (PR) per RECIST v1.1, with a higher response rate of 83% (10/12) in the dose levels selected for expansion (8 and 12 mg/kg) [9][13] - The disease control rate (DCR) was reported at 100% across all dose levels [13] - Notably, responses were observed in patients with low PD-L1 and/or CLDN18.2 expression [1][3] Safety Profile - The safety profile of givastomig was favorable, with no dose-limiting toxicities (DLT) observed and a maximum tolerated dose (MTD) not reached [14][15] - Common treatment-related adverse events (TRAEs) were generally Grade 1 or Grade 2, including nausea, vomiting, and fatigue, with rare Grade 3 TRAEs reported [14][15] Upcoming Events - Updated results from the study will be presented at the ESMO GI 2025 on July 2nd, and the company will host a virtual investor event on July 8th to discuss the findings [1][12]

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]

Core Viewpoint - I-Mab has regained compliance with Nasdaq's minimum bid price requirement, allowing its American Depositary Shares to continue trading on the exchange [1][2]. Company Overview - I-Mab is a U.S.-based global biotech company focused on developing precision immuno-oncology agents for cancer treatment [3]. - The company's leading pipeline product is givastomig, a bispecific antibody targeting Claudin 18.2, designed for treating Claudin 18.2-positive gastric cancers [3]. - Givastomig is being developed for first-line metastatic gastric cancers and shows potential in other solid tumors, demonstrating strong tumor-binding properties and anti-tumor activity in Phase 1 trials [3].

Core Points - I-Mab, a U.S.-based global biotech company, focuses on developing precision immuno-oncology agents for cancer treatment [1][2] - The management team of I-Mab will participate in the Jefferies Global Healthcare Conference from June 3-5, 2025, discussing clinical progress on its lead program, givastomig [1][2] - New data on givastomig has been accepted for a Mini Oral presentation at the ESMO Gastrointestinal Cancers Congress 2025, scheduled for July 2, 2025, in Barcelona, Spain [2] Company Information - I-Mab is headquartered in Rockville, Maryland, and has operations in Short Hills, New Jersey [2] - The company is publicly traded on NASDAQ under the ticker IMAB [1][2] - For more information, I-Mab's website and social media channels are available [2]

Core Insights - I-Mab has reported strong progress in its lead program, givastomig, aimed at treating gastric cancers, with patient enrollment in Phase 1b dose expansion cohorts completed ahead of schedule [2][3] - The company has a robust cash position of $168.6 million as of March 31, 2025, which is expected to fund ongoing studies and development initiatives into 2027 [6][8] - The anticipated milestones for givastomig include data presentations at the ESMO GI Congress in July 2025 and further updates in 2026 [3][4] Financial Performance - For Q1 2025, research and development expenses decreased to $0.8 million from $6.1 million in Q1 2024, primarily due to reimbursements and lower costs [10] - Administrative expenses increased to $4.5 million in Q1 2025 from $2.4 million in Q1 2024, influenced by changes in employee share-based compensation [11] - The net loss from continuing operations was $(3.2) million for Q1 2025, a significant reduction from $(9.4) million in Q1 2024, with net loss per share improving from $(0.05) to $(0.02) [15][17] Pipeline and Development - Givastomig is a bispecific antibody targeting CLDN18.2-positive tumor cells, currently in Phase 1b trials for first-line metastatic gastric cancers [18][20] - The ongoing Phase 1b study is evaluating givastomig in combination with nivolumab and chemotherapy, with enrollment in the first dose expansion cohort completed ahead of schedule [20][21] - The company is also developing uliledlimab and ragistomig in collaboration with partners, with updates expected in 2026 [4][8]