By Fineline Cube China-based biotech I-Mab (NASDAQ: IMAB) filed with the US Securities and Exchange Commission (SEC) that its co-development partner AbbVie Inc. (NYSE: ABBV) has decided to end a Phase Ib clinical trial of the CD47 monoclonal antibody (mAb) lemzoparlimab. The trial, which assessed the drug in combination with azacitidine and venetoclax, was for patients with myelodysplastic syndrome (MDS) and acute myelocytic leukemia (AML). The decision was not due to any specific or unexpected safety concerns.
Amended Agreement
The two companies have agreed to amend their original license and collaboration agreement from September 3, 2020. Under the new terms, AbbVie and I-Mab will continue to collaborate on the global development of CD47. AbbVie will pay up to USD1.295 billion in development, regulatory, and sales milestone payments, plus tiered royalties on global net sales outside Greater China for certain new anti-CD47 antibodies in development. I-Mab retains all rights to subsequent products in Greater China.
Original Deal and Future Plans
The original deal focused on lemzoparlimab (TJC4), with AbbVie paying USD180 million upfront and committing a further USD20 million based on Phase I results. Total milestone commitments were worth USD840 million. I-Mab stated it will continue developing lemzoparlimab, focusing on initiating a Phase III trial in Chinese MDS patients.
CD47 Development Context
Cluster of Differentiation 47 (CD-47) is a transmembrane protein that signals macrophages in the immune system not to engulf cells. It has been a target for cancer therapies. However, development in this area has faced challenges. Gilead Sciences acquired Forty Seven, Inc. for USD4.9 billion for magrolimab, a promising CD47 candidate, but clinical trials were halted in January and only resumed in April after safety reviews. Last week, Zai Lab Ltd (Nasdaq: ZAI) deprioritized its CD47-targeted molecule ZL-1201, seeking out-license partners instead.-Fineline Info & Tech