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13 Oct 2017

SGS and Bavarian Nordic to develop a novel and differentiated challenge model for RSV

Project will build upon the results of Phase II trials undertaken by Bavarian Nordic.

SGS has entered into collaboration with Bavarian Nordic to develop a new respiratory syncytial virus (RSV) challenge strain. This will assist with the advancement of a universal vaccine candidate designed to induce protective immune responses against both subtypes (A & B) of RSV.

The project will build upon the results of Phase II trials undertaken by Bavarian Nordic, and will include a human challenge study, which will be carried out at the SGS Clinical Pharmacology Unit in Antwerp, Belgium, using the new RSV challenge strain, once it has been fully developed and validated.

“This partnership combines expertise from both companies with a view to bring a truly life changing therapy to the market. SGS’s experience in both virus development, and in conducting human challenge trials safely and to exacting standards provides the potential to gain efficacy data concerning the vaccine prior to initiating a Phase III study,” commented Adrian Wildfire, Project Director, Infectious Diseases and Human Challenge Unit at SGS.

“SGS is an innovative company and the experience we gained from developing our novel H3N2 challenge strain to combat influenza has allowed us to look at new opportunities, such as this collaboration,” added Wim van Loon, Managing Director, SGS Benelux. “It is hoped that the result of this partnership will result in a new RSV vaccine being brought to market quickly and safely, ultimately benefiting patients.”

The collaboration comes after SGS’s success in the development of a novel GMP-manufactured, non-hemagglutinating, wild-type strain of Influenza A H3N2 (A/Belgium/4217/2015) which is approved for use as a challenge agent in studies demonstrating the early efficacy of influenza drugs and vaccines in healthy volunteers. The performance of the human challenge or the controlled human infection model (CHIM) and the value of the efficacy data associated is directly related to the quality of the challenge agent. With recent failures seen at phase III for a number of promising pipeline products, de-risking the late phase element of drug development is more important than ever. New influenza and RSV challenge agents, representing more recent circulating strains, with strong virological and host signals are essential for clinical evaluation if the model is to develop and provide the level of assurance required for successful candidate selection and progression.

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