ImmuneOncia Therapeutics and Lonza have entered into a manufacturing collaboration to support late-stage clinical development and potential commercial supply of Danburstotug (IMC-001), a PD-L1-targeting monoclonal antibody being investigated in immuno-oncology.

The agreement will see Lonza provide end-to-end development and manufacturing services covering both drug substance and drug product for Danburstotug. Drug substance production will take place at Lonza’s Slough site in the UK, while drug product development and clinical manufacturing will be carried out across its Basel and Stein facilities in Switzerland.

Danburstotug is a fully human monoclonal antibody designed as an immune checkpoint inhibitor targeting programmed death-ligand 1 (PD-L1). It is currently in clinical development for the treatment of relapsed or refractory NK/T-cell lymphoma, a rare and aggressive form of blood cancer affecting natural killer and T cells.

The collaboration is intended to support late-stage clinical supply as ImmuneOncia advances the programme towards potential regulatory pathways and commercial readiness. By working with an integrated contract development and manufacturing organisation, the company aims to streamline development across both upstream and downstream manufacturing processes.

NK/T-cell lymphoma represents a high-unmet-need indication, often requiring rapid development pathways and coordinated clinical manufacturing support due to its rarity and aggressive progression.

Under the terms of the agreement, Lonza will leverage its integrated biologics capabilities spanning process development, scale-up and clinical manufacturing. The company’s end-to-end model is increasingly used by biotech developers seeking to reduce transfer complexity between drug substance and drug product stages.

Heung-Tae Kim, chief executive officer at ImmuneOncia Therapeutics, said: “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 at 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.”

The agreement reflects continued demand for CDMO partnerships in late-stage biologics development, particularly in immuno-oncology, where manufacturing complexity and regulatory expectations increase significantly as assets progress through clinical phases.

Integrated manufacturing partnerships are becoming more common as biotech companies seek to reduce handovers between suppliers, improve comparability across clinical batches and accelerate readiness for potential commercial launch. This trend has been particularly evident in antibody-based therapies targeting immune checkpoint pathways such as PD-L1.

Lonza’s involvement also highlights the strategic importance of established global manufacturing networks in supporting clinical supply continuity across multiple regions, particularly for biologics requiring consistent quality control and scale-up capability.

ImmuneOncia’s collaboration with Lonza positions Danburstotug for continued late-stage development support as it moves through clinical evaluation in NK/T-cell lymphoma, with the potential for expansion into broader immuno-oncology indications depending on future trial outcomes.