Australian drug developer Implicit Bioscience and US/Danish contract development and manufacturing organization CMC ICOS Biologics have announced the execution of a production contract to support the next stage of development and commercialization of IC14, a clinical-stage, monoclonal antibody for acute lung injury. IC14 has a demonstrated safety profile in over 150 patient exposures, and initial data from a pilot clinical trial in mechanically-ventilated patients has provided a clear rationale for clinical development in ALI.
The two companies have concluded agreements for the accelerated manufacturing of drug substance, in anticipation of Phase II trials beginning early next year. In addition, Implicit has negotiated a non-exclusive license to utilize the CMC proprietary CHEF1 expression technology, a system that rapidly generates production cell lines and provides the flexibility to quickly increase manufacturing capacity as needed. Both agreements have been structured with an eye to future partnering for later-stage clinical trials and commercialization.
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