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BENCHMARKING A ROBUST, HUMAN-RELEVANT PANCREATIC MICROTISSUE PLATFORM FOR METABOLIC DRUG DISCOVERY AND T2D DISEASE MODELING

Obiettivo

Type 2 Diabetes (T2D) affects 537 million adults globally. The T2D drug market exceeds 50 billion USD annually, with GLP-1 receptor agonists as the fastest-growing class. Developing these drugs requires testing compounds on pancreatic beta cells, yet current models fail: rodent islets differ from human islets in architecture and receptor expression, contributing to a 92% clinical failure rate. Donor islets are scarce and variable. Cell lines lack physiological relevance. PancreaScale is a proprietary iPSC-derived platform that generates functional human pancreatic microtissues containing beta, alpha, and delta cells in 15 days using a chemically defined small-molecule protocol. Microtissues self-organize into 3D structures mimicking native islet architecture and demonstrate glucose-stimulated insulin secretion (GSIS). The protocol eliminates recombinant growth factors and animal-derived components, reducing cost of goods by over 90% while ensuring batch consistency from a master iPSC bank.Pan-NAM benchmarks PancreaScale against industrial standards defined by a global leader in metabolic drug development, who specified three validation criteria: (1) reproducible production with CV below 15% and Z-factor above 0.5 in 384-well format, (2) physiological insulin secretion response to GLP-1 agonists benchmarked against human islet data, and (3) a T2D disease model with blunted GSIS and proinsulin-to-insulin ratio above 15%. The 9-month project advances PancreaScale from TRL 4 to TRL 5 through three work packages: industrial scale-up, physiological validation, and T2D disease modeling.
Five Letters of Intent from partners spanning large pharma, contract research organizations, and specialized biotech confirm demand across the drug discovery value chain. The FDA Modernization Act 2.0 and EU Directive 2010/63/EU support adoption of validated human-relevant alternatives for metabolic drug screening.

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Coordinatore

STEMX BIO B.V.
Contributo netto dell'UE
€ 300 000,00
Indirizzo
GALILEIWEG 8
2333 BD Leiden
Paesi Bassi
PMI
Sì
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Collegamenti
Costo totale
Nessun dato