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I-Mab (IMAB) Shows 83% Response Rate for Givastomig in Metastatic Gastric Cancer
Yahoo Finance· 2025-09-23 23:12
In this article, we will be taking a look at the 15 Best Biotech Penny Stocks to Invest in Right Now. I-Mab stands second among them. I-Mab (NASDAQ:IMAB) is a U.S.-based biotechnology company focused on precision immuno-oncology, developing differentiated therapies for cancer. Its lead candidate, givastomig, is a bispecific antibody targeting Claudin 18.2 and 4-1BB, designed to selectively activate T cells within the tumor microenvironment, aiming to maximize anti-tumor effects while reducing common toxic ...
I-Mab Announces the Appointment of Seasoned Biotech Executives to the Board of Directors and the Scientific Advisory Board, and the Formation of a Research and Development Committee
GlobeNewswire News Room· 2025-08-25 11:00
Core Insights - I-Mab has appointed independent directors Dr. Robert Lenz and Ms. Xin Liu to its Board of Directors, effective August 22, 2025, and reiterated the appointment of Dr. Sean Cao as of May 28, 2025 [1][2][6] - The company has established a Research and Development Committee, chaired by Dr. Robert Lenz, to enhance its focus on R&D excellence and innovation [2][6] - Dr. Ken Takeshita has been appointed to the Scientific Advisory Board to strengthen I-Mab's capabilities in immuno-oncology [2][6] Company Developments - The new appointments are aimed at supporting I-Mab's strategic agenda and enhancing the Board's expertise as the company progresses with its lead product, givastomig [2][6] - Givastomig is a bispecific antibody designed to treat Claudin 18.2-positive gastric cancers, currently in Phase 1 trials, showing strong tumor-binding and anti-tumor activity [8] Board Member Profiles - Dr. Robert Lenz has extensive experience in R&D, previously serving as Executive Vice President at Neumora Therapeutics and holding key roles at Amgen and Abbott Laboratories [2][3] - Ms. Xin Liu is a finance executive with a background in healthcare investments, currently serving as Investment Director at Hony Capital [3][4] - Dr. Sean Cao is a biotech entrepreneur with a strong background in founding and leading biotech companies, currently an Operating Partner at CBC Group [4][5] - Dr. Ken Takeshita is a recognized biopharmaceutical executive with experience in clinical development and research, currently the Global Head of R&D for Daiichi Sankyo [5][6]
I-Mab to Participate in September Investor Conferences
Globenewswire· 2025-08-21 11:00
Core Viewpoint - I-Mab is actively participating in investor conferences in September 2025 to engage with potential investors and showcase its innovative pipeline in precision immuno-oncology for cancer treatment [1][2]. Group 1: Conference Participation - I-Mab's management team will attend the Cantor Global Healthcare Conference from September 3-5, 2025, focusing on one-on-one meetings [1]. - The company will also present at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025, at 9:30 AM ET, which will include a company presentation and one-on-one meetings [2]. Group 2: Company Overview - I-Mab is a U.S.-based global biotech company specializing in precision immuno-oncology agents for cancer treatment [3]. - The company's leading product candidate, givastomig, is a bispecific antibody targeting Claudin 18.2, designed for treating Claudin 18.2-positive gastric cancers [3]. - Givastomig is currently in Phase 1 trials, demonstrating strong tumor-binding and anti-tumor activity while minimizing common toxicities associated with other 4-1BB agents [3].
I-Mab Completes Enrollment in Planned Phase 1b Dose Expansion Study for Givastomig in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers
Globenewswire· 2025-08-11 11:00
Core Viewpoint - I-Mab has successfully completed enrollment in the Phase 1b dose expansion cohorts for givastomig, a bispecific antibody targeting Claudin 18.2, ahead of expectations, indicating strong interest and unmet needs in gastric cancer therapy [1][3]. Group 1: Study Details - The Phase 1b study (NCT04900818) is focused on evaluating the safety, efficacy, pharmacokinetics, and pharmacodynamics of givastomig in combination with nivolumab and mFOLFOX6 for CLDN18.2-positive gastric cancers [2]. - A total of 40 patients were enrolled in the dose expansion cohorts, with two doses being tested: 8 mg/kg and 12 mg/kg [2]. - The primary endpoint of the study is safety, and it exclusively enrolled patients in the U.S. [2]. Group 2: Clinical Data and Results - Data presented at the ESMO GI 2025 indicated an 83% objective response rate (ORR) for givastomig in combination with immunochemotherapy at the selected doses [3][8]. - The response onset was reported to be rapid, durable, and deepened over time, with favorable overall safety [3]. Group 3: Product Overview - Givastomig is a bispecific antibody designed to target Claudin 18.2-positive tumor cells and conditionally activate T cells through the 4-1BB signaling pathway [4][7]. - The drug is being developed for first-line metastatic gastric cancers, with potential applications in other solid tumors [4][7]. Group 4: Development Partnership - Givastomig is being developed through a global partnership with ABL Bio, where I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio [6]. Group 5: Future Expectations - The company expects to release topline results from the Phase 1b study in Q1 2026, following the positive data from the dose escalation phase [8].
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 to Present at the BTIG Virtual Biotechnology Conference
Globenewswire· 2025-07-14 11:00
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]
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]
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]
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 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].