I-Mab Advances Immunotherapy Pipeline with Uliledlimab, Givastomig, and Ragistomig
Key Insights
I-Mab (search) is preparing to file an IND for uliledlimab in combination with chemotherapy and checkpoint inhibitors for newly diagnosed NSCLC (search) patients in 1H 2024.
The first patient has been dosed in a triplet combination, dose escalation study of givastomig for gastric cancer (search) and esophageal adenocarcinoma (search) in 1Q 2024.
Strategic divestiture of assets and business operations in China is expected to close by the end of March 2024, impacting the company's financial condition.
I-Mab (search), a U.S.-based global biotech company, announced its full-year 2023 financial results and provided a business update, highlighting advancements in its immunotherapy pipeline. The company is focused on developing differentiated immunotherapies for cancer treatment, with key programs including uliledlimab, givastomig, and ragistomig. These assets are poised to reach critical milestones and trial initiations in the coming year.
Uliledlimab: Targeting CD73 in NSCLC
Uliledlimab, a CD73 (search) antibody, is being developed for non-small cell lung cancer (NSCLC (search)). The company plans to file an Investigational New Drug (IND) application in the first half of 2024 to evaluate uliledlimab in combination with chemotherapy and checkpoint inhibitors for newly diagnosed NSCLC patients.
Data from a Phase 2 study presented at ASCO 2023 showed encouraging results when uliledlimab was combined with toripalimab in advanced NSCLC (search) patients. Notably, patients with high CD73 (search) expression and PD-L1 (search) TPS > 1% exhibited a 63% overall response rate. The unique mechanism of uliledlimab, involving non-competitive binding with adenosine monophosphate and potential for complete inhibition of CD73's immune dampening function, differentiates it from other therapies in development.
Givastomig: Bispecific Antibody for Gastric and Esophageal Cancer
Givastomig, a Claudin 18.2 (search) x 4-1BB bispecific antibody, is currently in a Phase 1b study targeting gastric cancer (search) and esophageal adenocarcinoma (search). The first patient has been dosed in a triplet combination, dose escalation study in the first quarter of 2024, evaluating givastomig in combination with chemotherapy and a checkpoint inhibitor in frontline treatment for gastric and esophageal cancer.
Phase 1 monotherapy data presented at ESMO 2023 demonstrated encouraging objective responses in patients with gastric cancer (search) and esophageal adenocarcinoma (search) whose tumors progressed or recurred after prior standard treatments, even those with low levels of Claudin 18.2 (search) expression. Givastomig is designed to target Claudin 18.2-positive tumor cells, with conditional activation of pro-immune 4-1BB in the tumor microenvironment.
Ragistomig: Addressing PD-L1 Resistant Tumors
Ragistomig, a PD-L1 (search) x 4-1BB bispecific antibody, is in Phase 1 dose escalation, focusing on solid tumors. Early observations from the development partner, ABL Bio, have shown promising objective responses in patients with various solid tumors that progressed or recurred after prior standard treatments, including those with relapsed or refractory cancer after prior PD-L1 inhibitors. Ragistomig is designed to address PD-L1 resistant tumors by conditionally activating 4-1BB's pro-immune stimulation upon binding to its PD-L1 target. Top-line Phase 1 results are expected to be presented at a major medical conference in the first half of 2024.
Strategic Divestiture and Financial Position
I-Mab (search) is undergoing a strategic shift, with an agreement to divest its assets and business operations in China expected to close by the end of March 2024. This transaction will transfer the Greater China rights for assets including eftansomatropin alfa, felzartamab, uliledlimab, and givastomig to I-Mab Biopharma (Hangzhou) Co., Ltd. I-Mab will no longer bear future development costs for these divested assets in China and may receive up to US$80 million contingent on future regulatory and sales milestones. The transaction will also extinguish existing repurchase obligations of approximately US$183 million.
As of December 31, 2023, I-Mab (search) reported RMB2.3 billion (US$321.8 million) in cash, cash equivalents, and short-term investments. The company's net loss for the full year of 2023 was RMB1,465.7 million (US$206.4 million), compared to RMB2,507.3 million for 2022. Research and development expenses for the full year of 2023 were RMB810.6 million (US$114.2 million), compared with RMB904.9 million (US$131.2 million) for the full year of 2022.