XYLYX BIO, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

PROJECT ABSTRACT East River BioSolutions is developing novel cell culture substrates aimed at improving predictive in vitro models of idiopathic pulmonary fibrosisIPFto empower the investigation of IPF pathobiology and to accelerate drug development and testing of new effective IPF drugsIPF is a devastatingintractableand life threatening interstitial lung disease characterized by obliteration of pulmonary alveoli and progressive loss of respiratory functionOvernew cases of IPF are diagnosed each yearMedian survival isyearsand annual mortality in the US exceedsThe etiology and pathogenesis of IPF remain largely unknownPredictive animal and in vitro models of IPF for basic science research and drug development testing are severely lackingleaving a significant need and market opportunity for physiologically relevant experimental in vitro models and tools that enable quantitative mechanistic studies of IPFThis Phase I SBIR will bring a much needed commercial research tool into IPF research in the form of a fully humanizedD cell culture platform comprised of intact extracellular matrixECMthat recapitulates the IPF disease environment in vitroThe technological innovation is the set of proprietary methods for isolating acellular fibrotic human lung matrix with the intact structurecompositionand biomechanics associated with human IPF lung tissueThe associated long term goal is development and validation of a standard fully humanized fibrotic lung ECM scaffoldD cell culture substratefor predictive in vitro models of IPF in order to greatly reduce dependence on animal models and enable more meaningful and relevant results for scientists working to bring new life saving IPF drugs to marketThe hypothesis for Phase I is that fibrotic human lung ECM scaffolds can recapitulate the disease specific cellular environment of human IPF with approximatelysimilarity to the proteomic and biomechanical properties of fibrotic lung tissuethereby enabling significantly more relevant and predictive in vitro testing of novel IPF drugsSpecific aims are to determine primary molecular components and biomechanical properties of fibrotic lung ECM scaffolds and assess fibrotic scaffoldsability to support diseased fibroblast phenotype and IPF drug testingOnce Phase I aims are achievedassessing consistency of manufactured lots will be essential for commercializationThusin Phase IIwe will assess lot to lot consistency by quantitative quality control assays to inform development of a commercial manufacturing processEast River Bio will then make fibrotic ECM scaffolds commercially available through its online marketplace to scientists and companies in need of predictive IPF disease models for drug discovery and developmental testing aimed at improving treatment options for the more thansufferers of IPFThis product will become part of the rapidly growing cell culture marketvalued at $B inand estimated to reach $B byNarrative In this Phase I SBIREast River BioSolutions plans to develop a tissue specific biomaterial that will help scientists build more predictive in vitro models of pulmonary fibrosisthus enabling more accurate and actionable results aimed at accelerating drug development towards more effective treatment optionsPredictive models for pulmonary fibrosis drug development and testing are lackingthus leaving a significant need for experimental models enabling quantitative and mechanistic studiesThe ability to conduct more biologically faithful research will enable deeper scientific understanding by providing researchers with the ability to increase high impact discoveries toward saving patient livesproviding enormous potential to improve health outcomes