Implicit Bioscience and CMC Icos Biologics sign manufacturing agreement

Implicit Bioscience, a biopharmaceutical company, and CMC Icos Biologics, a contract development and manufacturing organization, have signed a manufacturing contract to support the next stage of development and commercialization of IC14, a clinical-stage monoclonal antibody for acute lung injury.

According to CMC, 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 acute lung injury. The company’s previous experience manufacturing IC14 makes them the ideal company to move the manufacturing process forward for this program.

The two companies have concluded agreements for the accelerated manufacturing of drug substance, in anticipation of Phase II trials beginning early in 2010.

In addition, Implicit has negotiated a non-exclusive license to utilize the CMC 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, CEO of Implicit Bioscience, said: We are pleased to be working with CMC Icos on the IC14 program, 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 program, and will facilitate future partnering activities.