Samsung Biologics and ImmuneOncia Therapeutics have achieved successful U.S. FDA IND approval of IMC-002 under a development and manufacturing agreement. As a result, ImmuneOncia will begin Phase 1 clinical trials of the pipeline product.
 
IMC-002 is an immune checkpoint inhibitor antibody, which blocks CD47-SIRP- α interaction between tumor cells and macrophages. According to ImmuneOncia, IMC-002 is expected to help patients with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas.
 
Leveraging Samsung Biologics’ global CDO capabilities, IMC-002 IND was approved by the FDA without significant comments. Samsung Biologics provided ImmuneOncia with services in cell line development, process development, non-clinical and clinical material production.
 
“We are very impressed with the outstanding service Samsung Biologics provided in the full development scope—from cell line development, process development, preclinical and clinical manufacturing, and IND filing support,” said Yun Jeong Song, chief executive officer, ImmuneOncia. “The two companies collaborated exceptionally well together during the whole development process including the IND evaluation period, allowing us to enter phase I clinical trials for IMC-002 much quicker.”
 
Dr. Tae Han Kim, chief executive officer, Samsung Biologics, said, “We are excited to join in ImmuneOncia’s success. This IND approval is the product of the strong collaboration between Samsung Biologics and ImmuneOncia. As a world-leading CMO, CDO and CRO partner, we will continue to support ImmuneOncia and ensure client satisfaction through Samsung’s competitive advantages: faster timeline, excellent quality, and outstanding capability.”