Workflow
I-Mab(IMAB)
icon
Search documents
I-Mab Presents Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025
Globenewswire· 2025-07-02 15:15
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]
金十图示:2025年07月01日(周二)热门中概股行情一览(美股盘初)
news flash· 2025-07-01 13:39
Market Capitalization Summary - TAL Education Group has a market capitalization of 14.284 billion [2] - Vipshop Holdings has a market capitalization of 8.942 billion [2] - 51Talk has a market capitalization of 7.770 billion [2] - New Oriental Education has a market capitalization of 6.304 billion [2] - 58.com has a market capitalization of 5.867 billion [2] Stock Performance - TAL Education Group's stock increased by 0.11 (+0.62%) [2] - Vipshop Holdings' stock decreased by 0.08 (-0.37%) [2] - 51Talk's stock increased by 0.12 (+0.22%) [2] - New Oriental Education's stock increased by 0.04 (+1.31%) [2] - 58.com’s stock increased by 0.28 (+0.63%) [2] Additional Company Insights - New Oriental Education's stock price is 18.29 [2] - Vipshop Holdings' stock price is 15.09 [2] - TAL Education Group's stock price is 3.48 [2] - 51Talk's stock price is 10.34 [2] - 58.com’s stock price is 12.00 [2]
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 Highlights Positive Givastomig Phase 1b Dose Escalation Data in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers at ESMO GI 2025
Globenewswire· 2025-06-26 10:30
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]
金十图示:2025年06月25日(周三)热门中概股行情一览(美股盘中)
news flash· 2025-06-25 16:40
Market Capitalization Summary - NIO has a market capitalization of 14.376 billion [2] - TAL Education has a market capitalization of 8.903 billion [2] - Vipshop has a market capitalization of 8.852 billion [2] - Miniso has a market capitalization of 6.079 billion [2] - JD Health has a market capitalization of 5.543 billion [2] Stock Performance - NIO's stock increased by 0.36 (+2.07%) [2] - TAL Education's stock decreased by 1.06 (-1.91%) [2] - Vipshop's stock decreased by 0.33 (-2.95%) [2] - Miniso's stock decreased by 0.59 (-1.29%) [2] - JD Health's stock decreased by 0.14 (-0.78%) [2] Additional Company Insights - Lufax Holdings has a market capitalization of 2.443 billion [2] - Huya has a market capitalization of 0.786 billion [3] - Xiaoniu Electric has a market capitalization of 0.286 billion [3] - Cheetah Mobile has a market capitalization of 0.116 billion [3] - Yunmi has a market capitalization of 0.094 billion [3]
金十图示:2025年06月24日(周二)热门中概股行情一览(美股盘中)
news flash· 2025-06-24 16:35
Market Capitalization Summary - TAL Education Group has a market capitalization of 14.104 billion [2] - Vipshop Holdings has a market capitalization of 8.066 billion [2] - 7.705 billion market capitalization for SouFun Holdings [2] - 6.042 billion market capitalization for WuXi AppTec [2] - 2.461 billion market capitalization for Lufax Holding [2] Stock Performance - TAL Education Group's stock increased by 0.75 (+3.77%) [2] - Vipshop Holdings' stock rose by 0.34 (+2.29%) [2] - SouFun Holdings saw a stock increase of 1.75 (+4.05%) [2] - WuXi AppTec's stock increased by 0.70 (+2.75%) [2] - Lufax Holding's stock rose by 0.05 (+1.79%) [2] Additional Company Insights - The stock of iQIYI increased by 0.38 (+4.04%) with a market cap of 2.417 billion [2] - Xunlei's market capitalization is 2.74 billion with a stock increase of 0.09 (+2.09%) [4] - The market cap of Huami is 0.1758 billion with a stock increase of 0.02 (+0.98%) [4]
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]
I-Mab (IMAB) Conference Transcript
2025-06-17 15:00
Summary of I-Mab (IMAB) Conference Call - June 17, 2025 Company Overview - **Company**: I-Mab (IMAB) - **Focus**: Development of innovative therapies for cancer, particularly targeting Claudin 18.2 in gastric cancer - **Current Status**: Transitioned to a capital-efficient model with a focus on the US market, following a divestiture of operations in China [6][12] Clinical Pipeline - **Key Asset**: Giva (Claudin 18.2 bispecific antibody) - **Clinical Stage**: Three clinical stage assets, with Giva being the primary focus [7][8] - **Upcoming Presentation**: Mini oral presentation scheduled for ESMO GI on July 2, 2025 [2][85] Core Points and Arguments - **Giva's Mechanism**: Giva is designed to enhance the standard of care for frontline gastric cancer without altering existing treatments [8][10] - **Efficacy Data**: - Monotherapy showed an Objective Response Rate (ORR) of 18% in heavily treated populations [9] - Combination studies with standard care (nivo chemo) demonstrated promising ORR and safety profiles [10][11] - **Market Opportunity**: - Addressable market for frontline Claudin 18.2 positive patients estimated at $12 billion in the US, EU, and Japan [11] - Gastric cancer is a significant unmet medical need with a low five-year survival rate of 7% for metastatic cases [10][11] Safety and Tolerability - **Safety Profile**: Giva demonstrated a favorable safety profile with minimal toxicity compared to other treatments [24][36] - **Comparison with Competitors**: Giva's grade 3 and above treatment-related adverse events were reported at 33%, significantly lower than competitors [41][42] Differentiation from Competitors - **Broad Eligibility**: Giva targets a wider range of Claudin 18.2 positive patients with a cutoff of 1% expression, unlike competitors with higher thresholds [31][39] - **Combination Potential**: Giva can be added to existing regimens without modifying standard care, making it suitable for frontline therapy [35][36] Future Development Strategy - **Focus on Gastric Cancer**: Commitment to developing Giva in frontline metastatic gastric cancer, with potential exploration in locally advanced settings and other GI cancers [55][75] - **Exploration of Other Tumor Types**: Interest in testing Giva in pancreatic and biliary tract cancers due to high Claudin 18.2 expression [55][75] Key Takeaways for Investors - **Upcoming Data**: Investors should look for data from the ESMO GI presentation, particularly regarding safety, efficacy, and the potential for Giva to improve patient outcomes [64][66] - **Long-term Potential**: Giva's unique properties and promising early data position it well for future success in treating gastric cancer and potentially other malignancies [84][85] Conclusion - I-Mab is poised for significant developments with Giva, focusing on addressing unmet needs in gastric cancer while maintaining a strong safety profile and broad eligibility for patients. The upcoming ESMO GI presentation is anticipated to provide critical data that could influence future investment and development strategies [82][84]
金十图示:2025年06月16日(周一)热门中概股行情一览(美股盘初)
news flash· 2025-06-16 13:38
Market Capitalization Overview - New Oriental has a market capitalization of 14.264 billion [2] - TAL Education (好未来) has a market capitalization of 8.983 billion [2] - Vipshop (唯品会) has a market capitalization of 7.770 billion [2] - Zai Ding Pharmaceutical (再鼎医药) has a market capitalization of 4.357 billion [2] - RELX has a market capitalization of 3.519 billion [2] Stock Performance - New Oriental's stock increased by 0.39 (+2.21%) [2] - TAL Education's stock increased by 1.00 (+5.02%) [2] - Vipshop's stock increased by 1.47 (+3.15%) [2] - Zai Ding Pharmaceutical's stock increased by 0.40 (+0.96%) [2] - RELX's stock increased by 0.37 (+2.98%) [2] Additional Companies - Huya (虎牙) has a market capitalization of 1.059 billion with a stock increase of 0.04 (+1.03%) [2] - iQIYI (爱奇艺) has a market capitalization of 2.479 billion with a stock increase of 0.14 (+1.52%) [2] - Lexin (乐信) has a market capitalization of 1.529 billion with a stock increase of 0.34 (+4.15%) [2] - Yihua Smart (宜人智科) has a market capitalization of 0.548 billion [2] Smaller Market Players - Sohu has a market capitalization of 0.323 billion with a stock decrease of 0.04 (-2.02%) [3] - Xiaoniu Electric (小牛电动) has a market capitalization of 0.257 billion [3] - Baozun (宝尊电商) has a market capitalization of 0.173 billion [3] - Huami Technology (华米科技) has a market capitalization of 0.164 billion [3]
I-Mab Regains Compliance with Nasdaq Minimum Bid Price Requirement
Globenewswire· 2025-06-12 11:00
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].