ImmuneOncia Therapeutics, Inc. and Lonza signed a manufacturing agreement to support late-stage clinical supply of Danburstotug (IMC-001), a PD-L1 antibody for immuno-oncology applications.
Danburstotug is a fully human monoclonal antibody designed as an immune checkpoint inhibitor targeting programmed death-ligand 1 (PD-L1). The therapy remains under clinical investigation for treating relapsed or refractory NK/T-cell lymphoma.
Under the agreement, Lonza will deliver development and clinical manufacturing services for both drug substance and drug product. Drug substance manufacturing will take place at Lonza’s Slough (UK) site. Drug product development and clinical manufacturing will occur at its Basel and Stein (Switzerland) sites.
ImmuneOncia will use Lonza’s integrated end-to-end development and manufacturing capabilities to support late-stage clinical development and potential commercialization. The collaboration draws on Lonza’s regulatory track record and its network spanning drug substance and drug product manufacturing.
“ImmuneOncia plans to target the rare cancer indication NKT cell lymphoma for early approval," advises Heung-Tae Kim, CEO, ImmuneOncia. "Our collaboration with Lonza serves as a testament to Danburstotug's technology and commercial value on the global stage, expected to create a favorable foundation for future global licensing and overseas market entry.”
Working in analytical science?
Register for a FREE Separation Science account to subscribe to the Separation Science Newsletter.
“Our collaboration with ImmuneOncia underscores our commitment to supporting biotech companies across their development pipeline and advancing their programs towards commercialization," adds Michael de Marco, Vice President of Commercial Development, Integrated Biologics, Lonza. "Our comprehensive end-to-end capabilities, spanning drug substance through to drug product manufacturing, will allow ImmuneOncia to focus on bringing Danburstotug to the global market.”
ImmuneOncia Therapeutics, Inc., founded in 2016 and based in South Korea, focuses on immuno-oncology. The company develops antibody-based therapeutics, including checkpoint inhibitors and bispecific antibodies, to address unmet needs in cancer treatment.
This article is based on a press release issued by Lonza.
