ROCKVILLE, MD, U.S. and SHANGHAI, China, October 16, 2023 – I-Mab (Nasdaq: IMAB) (the “Company”), a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics, today announced that the updated clinical results from its Phase 1 study of givastomig (also known as TJ-CD4B/ABL111) in advanced solid tumors will be reported in a poster presentation at the upcoming European Society for Medical Oncology (ESMO) Congress 2023, on Monday, October 23 at 12:00 p.m. CET.
|Abstract Title:||First-In-Human Phase I Study of Givastomig, A Novel Claudin 18.2/4-1BB Bispecific Antibody in Advanced Solid Tumors|
|Presenter:||Dr. Geoffrey Ku, Memorial Sloan Kettering Cancer Center|
|Session:||Poster Presentation: Investigational Immunotherapy|
|Location:||Hall 8, IFEMA Madrid, Spain|
|Presentation Date/Time:||Monday, October 23, 2023, 12:00 p.m. – 1:00 p.m. Central European Time|
The abstract is currently available on the ESMO website. Please visit the following link to read the full abstract.
Givastomig, also known as TJ-CD4B/ABL111, is a bispecific antibody designed to bind to Claudin 18.2 (CLDN 18.2) as a tumor engager and 4-1BB as a conditional T-Cell activator. It binds to tumor cells expressing various levels of CLDN18.2, i.e., gastric cancer and pancreatic cancer cells, and conditionally activates intra-tumoral T cells at the tumor site through the 4-1BB arm. Givastomig appears to effectively maintain a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both CLDN18.2 antibody and 4-1BB antibody while avoiding or minimizing liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. Being developed under collaboration between I-Mab and ABL Bio, a clinical-stage biotechnology company in South Korea, givastomig is currently being investigated in a Phase 1 clinical study in the U.S. and China. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction.
I-Mab (Nasdaq: IMAB) is a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics. I-Mab’s innovative pipeline is driven by internal R&D’s Fast-to-Proof-of-Concept, Fast-to-Market development strategies, and through global partnerships. For more information, please visit https://www.i-mabbiopharma.com and follow us 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 clinical studies of givastomig, the potential implications of clinical data for patients, and I-Mab’s advancement of, and anticipated clinical development, regulatory milestones, and commercialization of givastomig. 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 I-Mab’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, 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 I-Mab’s drug candidates; I-Mab’s ability to achieve commercial success for its drug candidates, 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 US 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.