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.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance