Through a deep understanding of the biology of the microenvironment and how its dysregulation drives fibrotic diseases and certain cancers, we develop novel, specifically directed therapies that change outcomes for patients.
XTuit is working on a pipeline of proprietary drug candidates addressing biological “master switches” and drivers of stromal disease. These proven pleiotropic stroma-normalizing mechanisms, include inhibition of extracellular matrix deposition and stabilization and reprogramming of various activated stromal cells to stop aberrant signaling that drives disease progression.
Critical to our approach is to ensure preferential biodistribution of active drug to the diseased tissue, lowering systemic exposure thereby avoiding unwanted adverse effects. We are exploring several novel delivery platforms that enable this preferential biodistribution to ensure maximal benefit risk ratio for our therapies.
We anticipate progressing to phase 1 clinical trials in 2018.
XTuit adopts a rigorous approach for prospectively predicting clinical drug response. It is based on a biomarker platform for digital imaging-based measurements of proteins and protein activity states. It also measures in vivo spatial relationships between cell types and tissue regions in the diseased stroma. The multi-dimensional information, overcomes limitations of disease heterogeneity and enables very accurate quantitation of bio-markers. Cutting edge integrated pattern recognition software allows the synthesis of multiple biomarkers to create a unique picture of disease drivers and potential drug sensitivity.
Since this approach is applicable to any type of tissue, we are able to interrogate human diseased tissue of interest from the early research phase. The biomarker platform is used to achieve comprehensive mechanistic understanding of pharmacokinetic-pharmacodynamic relationships of drug action and how those relate to efficacy in in preclinical models of human disease. Through this work we can develop a prototype quantitative clinical multiplex biomarker assay before phase 1 clinical trials, to prospectively predict drug benefit and retrospectively verify the desired drug mechanism-of-action in patients.
Patients with cancer and fibrosis need better therapies and they need them faster. We believe that our integrated biomarker precision medicine approach will enable XTuit to establish proof-of-efficacy already in phase 1b/2a in these areas of high unmet need. We anticipate that it will ultimately allow the patients most likely to benefit from our therapies to be enrolled in our trials, accelerating development and significantly enhancing the clinical benefit for those patients we treat.