AbbVie and I-Mab collaborate on lemzoparlimab
AbbVie and I-Mab to develop and commercialize I-Mab’s anti-CD47 monoclonal antibody lemzoparlimab
NORTH CHICAGO, Illinois & SHANGHAI—AbbVie Inc. and I-Mab Biopharma reported today that the companies have signed a broad, global collaboration agreement for the development and commercialization of lemzoparlimab (TJC4). The partners will also have the potential to expand the collaboration to additional transformative therapies.
Lemzoparlimab is an anti-CD47 monoclonal antibody which was discovered and developed by I-Mab. Lemzoparlimab is designed to minimize inherent binding to normal red blood cells, while preserving its strong anti-tumor activity — an attribute that may differentiate lemzoparlimab from other antibodies of the same class.
“Cancer is the second-leading cause of death globally and the need for novel cancer therapies has never been more acute,” said Thomas J. Hudson, M.D., senior vice president of R&D and chief scientific officer of AbbVie. “The addition of I-Mab’s novel CD47 programs complements our global clinical strategy in hematology and immuno-oncology. We have been impressed with what I-Mab has been able to accomplish in research and clinical development and we look forward to working together to make a meaningful difference in the lives of millions of patients globally.”
Under the terms of the agreement, AbbVie will pay I-Mab $180 million in an upfront payment to exclusively license lemzoparlimab, along with $20 million in a milestone payment based on the Phase 1 results. I-Mab will also be eligible to receive up to $1.74 billion in success-based milestone payments for lemzoparlimab, of which $840 million are based on clinical development and regulatory approval milestones. The remainder will be based on commercial milestones. Upon commercialization of lemzoparlimab, AbbVie will also pay tiered royalties from low-to-mid teen percentages on global net sales outside of greater China.
The collaboration provides AbbVie with an exclusive global license to develop and commercialize lemzoparlimab, with the exclusion of greater China. Both companies will collaborate to design and conduct further global clinical trials to evaluate lemzoparlimab in multiple cancers. I-Mab retains all rights to develop and to commercialize lemzoparlimab in mainland China, Macau and Hong Kong. The collaboration also allows for potential collaboration on future CD47-related therapeutic agents.
Both companies will share manufacturing responsibilities, with AbbVie taking the position of primary manufacturer for global supply. The collaboration is meant to accelerate I-Mab’s establishment of commercial production operations in China.
Topline results of the recent Phase 1 clinical trial confirm possible differentiation of lemzoparlimab in drug safety and a more favorable pharmacokinetics profile in cancer patients. Results have shown that lemzoparlimab is well tolerated as a single agent at a dose range of up to 30 mg/kg without any priming dose. In all evaluable patients, no dose-limiting toxicities or severe hematologic adverse events were observed. The companies plan to present full data at a scientific conference later this year.
Jingwu Zang, M.D., Ph.D., founder, honorary chairman and director of I-Mab, noted that “our goal at I-Mab has always been to bring transformational therapies to patients globally. This strategic collaboration reinforces I-Mab’s leading position in immuno-oncology and enables us to realize the full potential of our innovation. We are extremely proud to partner with AbbVie. By leveraging the combined development strength of our companies, we aim to speed lemzoparlimab to market for patients in need around the world.”