I-Mab Stock Price, News & Analysis

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.