I-Mab Announces Pipeline Progress and Financial Results for 1H 2024
Key Insights
I-Mab (search) completed the divestiture of its China operations, streamlining the organization and transitioning to a U.S.-based operating model.
Uliledlimab received IND clearance, paving the way for U.S. combination studies in first-line metastatic non-small cell lung cancer.
A clinical collaboration with Bristol Myers Squibb (search) will strengthen givastomig combination studies for first-line gastric cancer (search).
I-Mab (search) (NASDAQ: IMAB), a U.S.-based global biotech company, announced its financial results for the first half of 2024 and provided updates on its pipeline progress. The company is focused on developing highly differentiated immunotherapies for cancer treatment. Key highlights include the completion of the divestiture of its China operations, IND clearance for uliledlimab, a clinical collaboration with Bristol Myers Squibb (search) for givastomig, and promising early clinical results for ragistomig presented at ASCO 2024.
Uliledlimab (CD73 antibody) for mNSCLC
I-Mab (search)'s uliledlimab (TJ004309), a CD73 (search) antibody, is set to enter Phase 2 combination studies targeting first-line metastatic non-small cell lung cancer (mNSCLC (search)). Uliledlimab is designed to block CD73, a rate-limiting enzyme that promotes adenosine-driven immunosuppression within the tumor microenvironment. By blocking CD73, the antibody aims to enhance anti-tumor immunity.
Previous data from a single-arm Phase 2 study, presented at ASCO 2023, showed that uliledlimab combined with toripalimab achieved an overall response rate (ORR) of 63% in mNSCLC (search) patients with high CD73 (search) expression and PD-L1 (search) TPS ≥1%. The company has received IND clearance to initiate a randomized Phase 2 study evaluating multiple doses of uliledlimab plus pembrolizumab/chemotherapy versus pembrolizumab/chemotherapy alone, with patient enrollment expected to begin in the first half of 2025.
Givastomig (Claudin 18.2 x 4-1BB bispecific antibody) for Gastric Cancer
Givastomig (TJ033721 / ABL111), a bispecific antibody targeting Claudin 18.2 (search)-positive tumor cells, is currently undergoing Phase 1b dose expansion and combination studies, focusing on first-line metastatic gastric cancer (search). The antibody conditionally activates T cells via 4-1BB in the tumor microenvironment where Claudin 18.2 is expressed. I-Mab (search) is collaborating with ABL Bio (search) on this program, sharing worldwide rights excluding China and South Korea.
Phase 1 monotherapy data presented at ESMO Congress 2023 demonstrated encouraging objective responses in patients with metastatic gastric cancer (search) who had progressed or recurred after prior standard treatments, including those with low Claudin 18.2 (search) expression. I-Mab (search) has entered into a clinical collaboration and supply agreement with Bristol Myers Squibb (search) to evaluate givastomig in combination with nivolumab and chemotherapy as a potential first-line treatment for patients with advanced Claudin 18.2-positive metastatic gastric cancer. The study's primary endpoint is safety, with secondary endpoints including ORR, and data are expected in the second half of 2025. Updated clinical data from the dose expansion portion of the Phase 1 monotherapy study of givastomig will be presented at the ESMO Congress 2024.
Ragistomig (PD-L1 x 4-1BB bispecific antibody) for Solid Tumors
Ragistomig (TJ-L14B / ABL503), a bispecific antibody designed to provide anti-PD-L1 (search) activity and 4-1BB-driven T cell activation, is in Phase 1 dose escalation and dose expansion studies for advanced solid tumors (search). The combination of an Fc-silent antibody with conditional 4-1BB engagement is intended to improve safety, potentially reducing hepatotoxicity compared to traditional 4-1BB agonists. This program is also being developed in collaboration with ABL Bio (search).
Early data presented at ASCO 2024 by ABL Bio (search) showed promising objective responses in patients with various solid tumors (search) that had progressed or recurred after prior standard treatments, including those with relapsed or refractory cancer after prior PD-L1 (search) inhibitors. Top-line Phase 1 results demonstrated an ORR of 26.9% (7/26), including six partial responses (PR) and one complete response (CR), and a clinical benefit ratio (CBR) of 69.2% (18/26) at doses of 3 mg/kg and 5 mg/kg.
Financial Position
As of June 30, 2024, I-Mab (search) reported cash and cash equivalents, and short-term investments of $207.5 million, compared to $311.0 million as of December 31, 2023. This decrease included $49.4 million in one-time outflows related to the divestiture of the company's China operations. The company expects its cash runway to extend into 2027.