SHANGHAI, China, and GAITHERSBURG, MD – April 14, 2021 — I-Mab (the “Company”) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, today announced that its abstract on proprietary and highly differentiated CD73 antibody uliledlimab (also known as TJD5, or TJ004309) has been selected for detailed poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place virtually June 4-8, 2021.
Uliledlimab is a humanized CD73 antibody that works effectively as an anti-tumor agent through modulation of the tumor microenvironment by inhibiting the adenosine pathway that is implicated in tumor resistance to checkpoint immunotherapies. Uliledlimab is shown to strongly suppress tumor growth, especially when combined with a PD-(L)1 inhibitor, in pre-clinical studies. Uliledlimab interacts with a unique epitope involving a novel intra-dimer binding mode that enables its differentiated and favorable drug properties.
I-Mab presented a poster on the mechanistic findings underlying the differentiation, together with the preclinical research of uliledlimab, on April 10 at the 2021 American Association for Cancer Research (AACR) Annual Meeting.
I-Mab has made significant progress in the global clinical development of uliledlimab. In February 2021, I-Mab has completed the initial assessment of its U.S. clinical study investigating uliledlimab as a monotherapy lead-in followed by combination with atezolizumab (Tecentriq®) in patients with solid tumors. Topline results from the clinical study under contract with TRACON show that uliledlimab is safe and well tolerated at the dose range evaluated and demonstrate clinical activity in patients with advanced solid tumors.
About Uliledlimab (TJD5)
Uliledlimab (TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine in turn binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in tumor microenvironment. Uliledlimab is expected to offer clinical benefit by suppressing tumor growth in concert with checkpoint therapies such as PD-1 and PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties as evident in preclinical studies.
I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development and soon commercialization of novel and highly differentiated biologics in immuno-oncology therapeutic area. The Company's mission is to bring transformational medicines to patients around the world through drug innovation. I-Mab's globally competitive pipeline of more than 15 clinical and pre-clinical stage drug candidates is driven by its internal R&D capability and global licensing partnerships, based on the Company's unique Fast-to-Proof-of-Concept and Fast-to-Market pipeline development strategies. The Company is now rapidly progressing from a clinical stage biotech company to a fully integrated global biopharmaceutical company with cutting-edge global R&D capabilities, a world-class GMP manufacturing facility and commercialization capability. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://ir.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter and WeChat.
I-Mab Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the TJD5 clinical trials, the potential implications of clinical data for patients, and the advancement by I-Mab, and anticipated clinical development, regulatory milestones and commercialization of TJD5. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to the ability of I-Mab to demonstrate the safety and efficacy of TJD5; the clinical results for the drug candidate, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of the drug candidate; the ability to achieve commercial success for the drug candidate, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company’s clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.