Implicit Bioscience Ltd and CMC ICOS Biologics announced the execution of a manufacturing contract to support the next stage of development and commercialisation of IC14, a clinical-stage monoclonal antibody for acute lung injury (ALI). 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.
CMC ICOS is a company dedicated to contract development and manufacturing for the biotechnology sector. The company's previous experience manufacturing IC14 makes them the ideal company to move the manufacturing process forward for this programme. 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.
Garry Redlich, Implicit Bioscience CEO, commented, "We are pleased to be working with CMC ICOS on the IC14 programme, and appreciate their particular insights gained over their years of experience in the earlier development of this antibody. We believe that the accelerated timelines that are part of this agreement will be important assets to the value of the programme, and will facilitate future partnering activities."
Gustavo Mahler, CMC ICOS president, noted, "We are pleased to be able to continue our significant role in the IC14 programme, and to continue to expand our leadership role in the field of protein production. The Implicit and CMC ICOS teams are already well integrated and working closely to move this programme forward on an accelerated basis."
IC14 is a clinical stage recombinant chimeric monoclonal antibody which recognizes and blocks the function of human CD14, an essential component of the innate inflammatory response to bacterial infection. CD14 triggers activation of the innate immune response to bacterial components including lipopolysaccharide via the Toll-like receptor (TLR) pathway.
CMC ICOS Biologics is a leading contract development and manufacturing organization that provides fully integrated biopharmaceutical development and manufacturing services to clients around the world.
Implicit Bioscience is a public unlisted Australian biopharmaceutical company based in Brisbane (Australia) and Seattle, that develops drugs which modulate the host immune response to disease.