clinical trialCobra Biologics, international CDMO of biologics and pharmaceuticals, has been appointed by the University of Sheffield to provide a comprehensive manufacturing service for a potential growth hormone (GH) antagonist created using ProFuse Technology originally developed by the University of Sheffield.

This work will allow Sheffield University to progress toxicology trials and prepare for Phase I clinical trials, with the help of the Medical Research Council (MRC): Developmental Pathway Funding Scheme (DPFS) provided by the UK Biomedical Catalyst.

ProFuse Technology is a novel fusion technology in which hormones are fused to the extracellular domain of their receptors. The resulting fusion protein has a longer circulation half-life than the native hormone as it is larger in size, and is able to compete with the natural hormone for receptor binding.

Cobra will be using its cell line development service, maxXpress, to produce the GH antagonist fusion protein. By disrupting GH binding and thus preventing the cellular changes normally initiated by the hormone, it is hoped that the protein will be successful in the treatment of patients suffering from Acromegaly, a condition of excessive body growth due to GH over-production. This condition results in increased morbidity and mortality.

Peter Coleman, CEO of Cobra Biologics, commented: “I am very pleased that The University of Sheffield has chosen Cobra to manufacture the ProFuse growth hormone antagonist. Cobra’s maxXpress service has proven very popular with customers. The service combines the UCOE technology and Cobra’s cell development team providing the optimum combination to take their protein forward to clinical trials.”

Professor Richard Ross, the University of Sheffield’s Principle Investigator on the DPFS grant, said: “This is a major step forward in our MRC funded programme to develop a new cost-effective treatment for patients with Acromegaly. We are delighted to work with Cobra who has the experience and technology to rapidly manufacture our ProFuse growth hormone antagonist for clinical trials.”

As part of the comprehensive service, Cobra will be providing scale-up and non-GMP manufacture at 250 L, formulation development and fill-finish.