PrDx - Advanced Software for Predicting the Immune Response During Drug Development

Project Information

ImmuniPrDx

Grant agreement ID: 867120

DOI

10.3030/867120

Project closed

EC signature date 11 May 2019

Start date 1 June 2019

End date 30 September 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

IMMUNITRACK APS
Denmark

Periodic Reporting for period 1 - ImmuniPrDx (PrDx - Advanced Software for Predicting the Immune Response During Drug Development)

Reporting period: 2019-06-01 to 2019-09-30

Summary of the context and overall objectives of the project

The average drug life-cycle costs are estimated at €2.9bn. The major factor contributing to the high cost is product failure, as around 9/10 drug candidates fail to win approval. This results in scarce and expensive drugs. A major reason for failure is occurrence of immunogenicity issues late in the development cycle caused by inadequate molecular design which often results in drug/vaccine candidates with unwanted immune responses - causing significant wastes of time and money for drug developers. Being able to filter out drug candidates prone to promote such adverse events would have major and positive consequences for patient safety, on effectiveness of health treatments and on industry costs.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Immunitrack has developed, a next generation Epitope Immunogenicity Prediction Software (EIPS) – PrDx - with unmatched levels of epitope prediction performance, easily exceeding the current EIPS gold standard, netMHC. There is strong need for such software for early drug immunogenicity assessment – as adverse or inadequate immune response of novel drugs being developed is causing significant wastes of time and money. During the course of this SME phase I project, Immunitrack has gained an understanding of the regulatory needs for PrDx, worked closely with pharma to address features that should be implemented in PrDx, and gained an understanding on how the product should be shaped to be commercially attractive. Immunitrack has also been presenting and networking at various conferences to understand better the needs from customers and studied the competitive landscape. The outcome of this project is a better understanding and preparation to further develop and commercialize PrDx.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Immunitrack aim at becoming the best-in-class deliverer of immune prediction tools, and will with the commercialization of the EIPS PrDx significantly increase the level, of benefit for drug and vaccine developers, clinicians and in the end, patients. With PrDx, we will be able to scale up, while providing a hitherto unseen level of precision and performance, securing our position as frontrunners in a billion-euro market. PrDx can be applied as a stand-alone product, and also supplement our current products – leveraging the sales of these, making Immunitrack the one-stop-shop for immunigenecity prediction and the partner of choice during drug and vaccine development. PrDx represents our passport to growth, with estimated revenues of €56M 5 years post ImmuniPrDx Innovation Project.

Immunitrack business model and concept