Samsung Biologics and STCube have formed a strategic development and manufacturing service agreement for STT-003 antibody, an anti-cancer drug candidate.
 
Under the agreement, Samsung Biologics will offer a wide range of services from cell line development, process development, manufacturing of non-clinical and clinical material, to IND submission for STCube.
 
STCube is an innovation-driven biopharmaceutical company developing breakthrough cancer therapies with its cutting-edge research. STCube decided to establish a strategic partnership with Samsung Biologics based on the rapid growth of the company’s development and manufacturing capabilities and solid positioning in the global market as a world-class CDO. The two companies made an agile move into an agreement as it took only two weeks from the initial stage of discussion to the completion of the contract.
 
STT-003 antibody, developed by STCube’s US based research center located in Maryland, has been a subject of a Material Transfer Agreement (MTA) between STCube and a multinational pharmaceutical company.
 
A novel immune checkpoint STT-003 is found to extensively express over the surfaces of immune and cancer cells, suppressing their immune functions. Partly because of this high expression of STT-003 in various cancer cells, therapies targeting STT-003 are expected to exhibit more favorable anti-cancer effects than conventional PD-1/PD-L1 therapies.
 
STCube is planning to submit an IND on its STT-003 antibody in 2021, both for the use as monotherapy and the use in combination therapy. Clinical trials are currently being planned at leading medical institutions in the U.S.
 
“We have signed a contract with Samsung Biologics, a global CMO, CDO and CRO company, to produce first-in-class STT-003 antibody, laying the foundation for stable implementation of global clinical trials,” said Hyun-Jin Jung, chief executive officer, STCube. “So far, several globally recognized immunologists have agreed to serve on the scientific advisory board for phase I clinical studies of STT-003 antibody, including the head of clinical research at a world leading clinical institution for cancer treatment.”
 
Tae Han Kim, chief executive officer, Samsung Biologics, said, “We are proud to contribute to the development of this exciting novel target anti-cancer drug candidate through our continued partnership. As a world-leading CMO, CDO and CRO partner, we will continue to offer Faster & Better service to our clients for maximum client satisfaction through Samsung’s competitive advantages: faster timeline, excellent quality, and outstanding capability.”