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I-Mab (IMAB) Shows 83% Response Rate for Givastomig in Metastatic Gastric Cancer
Yahoo Financeยท 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 Roomยท 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
Globenewswireยท 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 Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswireยท 2025-08-20 11:00
Core Insights - I-Mab has reported transformative progress in the first half of 2025, particularly with the promising Phase 1b combination data for its drug givastomig, which targets Claudin 18.2 for metastatic gastric cancers [2][3] Financial Performance - For the three months ended June 30, 2025, the company reported a net loss of $5.5 million, compared to a net loss of $8.9 million for the same period in 2024 [16] - For the six months ended June 30, 2025, the net loss was $8.7 million, an improvement from a net loss of $18.4 million in the same period in 2024 [16] - Research and development expenses decreased to $3.3 million for the three months ended June 30, 2025, down from $5.2 million in 2024 [10] - Administrative expenses also decreased to $3.8 million for the three months ended June 30, 2025, compared to $11.9 million in 2024 [11] Cash Position - As of June 30, 2025, I-Mab had cash and cash equivalents of $165.6 million, which is expected to fund operations through the fourth quarter of 2028 [7][6] - The company raised approximately $61.2 million from an underwritten offering in August 2025, strengthening its balance sheet [6] Clinical Developments - Givastomig demonstrated an 83% objective response rate in a Phase 1b study when combined with immunochemotherapy, with topline data expected in Q1 2026 [3][6] - The company has completed enrollment for the Phase 1b dose expansion study of givastomig in combination with nivolumab and mFOLFOX6 for first-line metastatic gastric cancers [3] Upcoming Milestones - I-Mab anticipates updates in 2026 for other programs, including ragistomig and uliledlimab, which are under development by ABL Bio and TJ Biopharma, respectively [4] Shareholder Information - As of June 30, 2025, the company had 188,108,178 ordinary shares outstanding, which will increase to 264,774,837 shares post-offering [8][9]
I-Mab Completes Enrollment in Planned Phase 1b Dose Expansion Study for Givastomig in Combination with Immunochemotherapy in Patients with 1L Gastric Cancers
Globenewswireยท 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 Announces Pricing of $65 Million Underwritten Offering of American Depositary Shares
Globenewswireยท 2025-08-01 12:00
Core Viewpoint - I-Mab has announced a public offering of American Depositary Shares (ADSs) to raise approximately $65 million for clinical development and general corporate purposes [1][3]. Group 1: Offering Details - The offering consists of 33,333,334 ADSs, priced at $1.95 per ADS, representing a total of 76,666,668 ordinary shares [1]. - The offering is expected to close on August 5, 2025, subject to customary closing conditions [1]. - Participation in the offering includes both new and existing investors such as Everest Medicines and Janus Henderson Investors [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund ongoing clinical development of pipeline product candidates, including a Phase 2 trial of givastomig [3]. - Givastomig is a bispecific antibody targeting Claudin 18.2, aimed at generating clinically meaningful progression-free survival data by the end of 2027 [3]. Group 3: Company Overview - I-Mab is a U.S.-based global biotech company focused on precision immuno-oncology agents for cancer treatment [6]. - The company's lead product, givastomig, is designed to treat Claudin 18.2-positive gastric cancers and is currently in Phase 1 trials [6].
I-Mab Strengthens Givastomig Intellectual Property Portfolio through Acquisition of Bridge Health
GlobeNewswire News Roomยท 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
Globenewswireยท 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
Globenewswireยท 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 Announces Publication of Givastomig Monotherapy Data in Clinical Cancer Research
Globenewswireยท 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]