SGS, a life sciences contract research organization (CRO) headquartered in Switzerland, announced that it has entered into collaboration with Bavarian Nordic A/S, an international biotechnology company specializing in vaccines, 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.
RSV is recognized as a significant cause of respiratory illness in all age groups. It is highly infectious and the most common cause of lower respiratory tract infections in pediatric populations worldwide, resulting in a high number of hospitalizations. RSV infections are also a serious health concern in the elderly and in adults with cardiopulmonary disease. According to WHO estimates, RSV infects more than 64 million people globally each year and causes a similar number of deaths to those caused by influenza. However, while there is a vaccine to prevent influenza, there is no vaccine to prevent RSV. There are only two subtypes of RSV, A and B, which are typically present either simultaneously or alternately during yearly epidemics.
“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.