ImmuneOncia Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on immuno-oncology, and Lonza, one of the world’s largest contract development and manufacturing organizations (CDMOs), announced today that the companies signed a manufacturing agreement for late-stage clinical supply of Danburstotug (IMC-001).
Danburstotug is a fully human monoclonal antibody designed as an immune checkpoint inhibitor targeting the programmed death-ligand 1 (PD-L1) and under clinical investigation for treating relapsed/refractory NK/T-cell lymphoma.
Under the terms of the agreement, Lonza will provide development and clinical manufacturing services for drug substance and drug product. Drug substance will be manufactured at its Slough (UK) site, and drug product development and clinical manufacturing will be provided at its Basel and Stein (CH) sites.
ImmuneOncia leverages Lonza’s end-to‑end development and manufacturing expertise, backed by a strong regulatory track record and an integrated drug substance and drug product manufacturing network for its late clinical and commercial readiness phases.
Heung-Tae Kim, CEO, ImmuneOncia, added: “ImmuneOncia plans to target the rare cancer indication NKT cell lymphoma for early approval. 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.”
Michael de Marco, Vice President of Commercial Development, Integrated Biologics, Lonza, said: “Our collaboration with ImmuneOncia underscores our commitment to supporting biotech companies across their development pipeline and advancing their programs towards commercialization. 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.”
