I-Mab and Bristol Myers Squibb to Evaluate Givastomig for New Gastric and Esophageal Cancers

I-Mab has entered into a clinical trial collaboration agreement with Bristol Myers Squibb to investigate the potential of a novel cancer treatment. This collaboration focuses on evaluating givastomig, a Claudin 18.2 x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy for treating advanced gastric and esophageal cancers. This effort builds on previous positive findings from a monotherapy study of givastomig presented at the European Society of Medical Oncology Congress 2023.

I-Mab, a U.S.-based biotechnology company dedicated to developing innovative immunotherapies for cancer, will conduct a multinational Phase 1 study under this collaboration. Bristol Myers Squibb will supply nivolumab, an immune checkpoint inhibitor designed to block the PD-L1 protein on cancer cells, thereby enhancing T-cell function and improving anti-tumor responses. The combination therapy, involving givastomig, nivolumab, and chemotherapy (FOLFOX or CAPOX), aims to serve as a first-line treatment for patients with advanced Claudin 18.2-positive gastric and esophageal cancers.

Raj Kannan, CEO of I-Mab, expressed optimism about this collaboration, highlighting the encouraging single-agent activity and safety profile of givastomig observed in earlier studies. Kannan believes that combining givastomig with nivolumab and chemotherapy could lead to significant anti-tumor activity in specific tumor types and is eager to advance this combination therapy in clinical trials.

Givastomig, also known as TJ-CD4B/ABL111 or TJ033721, is a bispecific antibody designed to target Claudin 18.2 (CLDN18.2) on tumor cells and activate intra-tumoral T-cells through 4-1BB. This dual mechanism allows givastomig to bind strongly to tumor cells expressing CLDN18.2, such as those found in gastric and pancreatic cancers, while activating T-cells at the tumor site. The antibody aims to maintain strong tumor binding and anti-tumor activity through the synergistic effects of both CLDN18.2 and 4-1BB, while minimizing liver toxicity and systemic immunotoxicity, common issues with 4-1BB antibodies.

Givastomig is currently undergoing a Phase 1 clinical study in the U.S. and China. In March 2022, the U.S. Food and Drug Administration granted Orphan Drug Designation for givastomig for the treatment of gastric cancer, including cancer of the gastroesophageal junction.

I-Mab is a global biotech company with operations in Rockville, Maryland, and San Diego, California. The company's focus is on developing and potentially commercializing highly differentiated immunotherapies for cancer treatment. This new collaboration with Bristol Myers Squibb represents a significant step in I-Mab's efforts to advance givastomig as part of a combination therapy for cancer treatment.

This collaboration and the ongoing development of givastomig highlight I-Mab's commitment to exploring innovative cancer therapies. The potential of givastomig, particularly in combination with nivolumab and chemotherapy, could offer new hope for patients with advanced gastric and esophageal cancers. The results of the upcoming clinical trials will be crucial in determining the efficacy and safety of this combination therapy, potentially leading to new treatment options for cancer patients.