The platform is designed to integrate development areas in API manufacture, formulation development, clinical supply, safety assessment, drug metabolism and pharmacokinetics, bioanalysis studies, and regulatory submission documents preparation.
“The INDiGO platform’s future evolution is around keeping track in real time, or if possible precede, science and regulatory advancements, while identifying further ways to improve speed retaining quality and limiting risks,” Gabriele Hansen, vice president of corporate communication and investor relations, told Outsourcing-Pharma.
Evotec has been working with Carna Biosciences since 2017 and the companies hope to submit an investigational new drug (IND) application with the US Food and Drug Administration (FDA) in the first half of 2019.
“Carna Biosciences has in the pipeline very promising treatments in the oncology area using BTK [Bruton’s tyrosine kinase] inhibitors, areas in which we have a wealth of experience and our hope by establishing this partnership is to be able to effectively contribute to the development of transformative medicines in this area of unmet needs,” explained Hansen.
Germany-based Evotec – which is preparing to legally convert to a European Company – is also working with Carna Biosciences to increase its presence in the Japanese market.
Carna Biosciences currently has another reversible BTK inhibitor in pre-clinical development, AS-871, a novel non-covalent BTK inhibitor targeting autoimmune diseases. It is also undergoing IND-enabling studies in partnership with Evotec.