Welcome to our dedicated page for I-Mab news (Ticker: IMAB), a resource for investors and traders seeking the latest updates and insights on I-Mab stock.
I-Mab (NASDAQ: IMAB), now known as NovaBridge Biosciences, generates a steady flow of news as a U.S.-based, global biotech company focused on precision immuno-oncology. Investors following IMAB-related headlines can track how the company advances its lead Claudin 18.2 x 4-1BB bispecific antibody, givastomig, and other pipeline assets through clinical milestones, strategic transactions, and capital markets activity.
News coverage commonly highlights clinical data from Phase 1 and Phase 1b studies of givastomig in Claudin 18.2-positive gastric and gastroesophageal cancers, including monotherapy results and combination regimens with immunochemotherapy in the first-line metastatic setting. Company announcements describe objective response rates, safety findings, and study design details from presentations at major oncology conferences such as ESMO GI and the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics meeting.
Beyond clinical readouts, IMAB news items also cover the company’s broader transformation into a global biotech platform under the NovaBridge Biosciences name. Releases discuss the adoption of a hub-and-spoke business model, the formation of subsidiaries like Visara, Inc. for VIS-101 in ophthalmology, and strategic agreements with partners including ABL Bio, AffaMed Therapeutics, AskGene Pharma, and Everest Medicines. Capital markets updates, such as underwritten offerings of American Depositary Shares and intentions to pursue a dual listing on the Hong Kong Stock Exchange, are also key themes.
On this news page, readers can review company press releases, SEC-referenced announcements, and other IMAB-related updates in one place. For investors and researchers, regularly checking this feed offers insight into clinical progress, partnership activity, governance changes, and financing events that shape the outlook for I-Mab’s, and NovaBridge Biosciences’, oncology and ophthalmology programs.
I-Mab (Nasdaq: IMAB) has announced the appointment of John Long as Chief Financial Officer and Jielun Zhu as Chief Strategy Officer, effective immediately. These appointments are aimed at enhancing I-Mab's executive leadership as it transitions into a global biopharma company. Long brings over 20 years of financial management experience, while Zhu, the former CFO, will focus on strategic corporate development. The company is advancing its commercialization plans for late-stage assets, promising growth opportunities.
I-Mab has formed a strategic partnership with Sinopharm to enhance its commercial capabilities in China. The collaboration grants over 300 Sinopharm subsidiaries authorization as distributors, aiming to streamline the go-to-market process for I-Mab's innovative therapies. I-Mab is on track to submit its Biologics License Application (BLA) for a third-line multiple myeloma treatment in Q4 2021. This partnership supports I-Mab's goal of transitioning to a fully integrated biopharmaceutical company with robust manufacturing and commercialization capabilities.
I-Mab (Nasdaq: IMAB) is expanding its U.S. operations by establishing a new R&D site in San Diego, aimed at enhancing its global drug development capabilities. This site will complement its existing facility in Gaithersburg, Maryland, forming an integrated U.S. R&D center that supports clinical studies across China and the U.S. The company aims to attract top talent and invest significantly over the next two years, focusing on immuno-oncology and translational medicine, to advance its innovative pipeline of over 20 assets.
I-Mab (Nasdaq: IMAB) announced the approval of its IND submission for a phase 2 clinical trial of efineptakin alfa in combination with PD-1 therapy for patients with advanced solid tumors, including triple-negative breast cancer and head and neck cancers. Efineptakin alfa is a long-acting recombinant human interleukin-7 aimed at boosting T lymphocytes for cancer treatment. Previous studies indicated its safety and efficacy, significantly increasing T-cell numbers and achieving a notable overall response rate in metastatic TNBC. The trial initiation represents a significant step in advancing I-Mab's innovative pipeline.
I-Mab (NASDAQ: IMAB) has completed patient enrollment for its phase 3 trial of felzartamab, a human CD38 antibody, in combination with lenalidomide for second-line treatment of multiple myeloma (MM). The trial aims to evaluate progression-free survival compared to lenalidomide and dexamethasone. The company plans to submit a Biologics License Application (BLA) for this treatment in Q4 2021. Additionally, an IND application for felzartamab in combination with another asset for first-line treatment is also scheduled for Q4 2021.
On October 5, 2021, I-Mab (Nasdaq: IMAB) and ABL Bio announced the upcoming presentation of preclinical data for two bispecific antibodies, TJ-CD4B/ABL111 and TJ-L14B/ABL503, at the Society for Immunotherapy of Cancer's Annual Meeting from November 12-14, 2021. TJ-CD4B/ABL111, targeting Claudin18.2 in gastric and pancreatic cancers, is in Phase 1 trials in the U.S. TJ-L14B/ABL503, designed to enhance anti-tumor activity while minimizing toxicity, is also in Phase 1 trials. The announcement underscores I-Mab's commitment to advancing innovative therapies in cancer treatment.
I-Mab (Nasdaq: IMAB) announced its participation in two upcoming conferences in October. The J.P. Morgan Global Healthcare Conference, held from October 12-13 in Shanghai, and the virtual Jefferies China Biotech Summit on October 26, 2021, will feature key management personnel including the founder and CEO. I-Mab focuses on the development of innovative biologics, particularly in immuno-oncology, and is transitioning towards becoming a fully integrated global biopharmaceutical company with extensive R&D and manufacturing capabilities.
I-Mab (Nasdaq: IMAB) announced significant clinical advancements for its anti-CD47 monoclonal antibody, lemzoparlimab. The phase 2 trial for non-Hodgkin's lymphoma (NHL) is now multi-centered, including sites in China, with preliminary data submitted for the ASH 2021 presentation. Concurrently, the AML/MDS trial is on track for patient enrollment completion by Q4 2021. Furthermore, the NMPA has approved a phase 2 trial for lemzoparlimab combined with toripalimab for advanced solid tumors. These advancements position I-Mab favorably for upcoming registrational trials in China.
I-Mab (Nasdaq: IMAB) announced that China's NMPA has accepted its IND application to initiate a Phase 2 trial for enoblituzumab combined with pembrolizumab (Keytruda®) in patients with selected solid tumors. This trial aims to evaluate the efficacy of enoblituzumab, a monoclonal antibody targeting B7-H3, which is linked to poor cancer prognosis. Data from previous studies suggest potential positive treatment outcomes. The trial, involving cancers like non-small cell lung cancer (NSCLC) and urothelial carcinoma, leverages prior clinical data from MacroGenics to expedite development in Greater China.
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