Although cancer is a leading cause of death globally, oncology drugs have the lowest success rates, cost themost to develop, and constantly show promising results in animals and then fail to work in patients. Thus, thereis a need for models that facilitate understanding of how a drug will work in humans and for specific patientpopulations. The availability of human tumor samples will further facilitate enhanced preclinical screening, wherelong timelines (>10 years), high costs ($2.6B), and low success rates (1/5,000) plague the development of newdrugs. Link Biosystems provides a universal approach to tumor cell expansion via a custom bioreactor productthat uses a defined serum-free media and relies on controlled aggregation for enhanced paracrine signaling andcell-cell contact, enhanced nutrient delivery via low-shear perfusion, and organotypic tissue niches to generatethousands of identical immunocompetent tumoroid tissues that can be further scaled as needed. This approachwould enable the establishment of robust tumor models for early and late stage cancers, rare cancers, andpreviously biobanked samples at quantities suitable for screening large drug panels - includingimmunotherapies, biologics, and drug-drug combinations, to find an optimally effective drug regimen for thespecific patient. Additionally, the ability to generate quality-controlled patient cells at scale will enable theestablishment of patient tumor biobanks and subsequent personalized drug screening for optimal treatmentguidance and to overcome drug resistant phenotypes. To this end, we are similarly evaluating our bioreactorsversatile utility for expansion of direct patient tumor samples and previously biobanked organoid models,providing the raw material needed for downstream drug screening assays that are human, robust, reproducible,incorporates immune and stromal components, and captures the heterogeneity of patient responses.
Public Health Relevance Statement: Narrative
In this Phase I SBIR, Link Biosystems, Inc. Overall, the Phase I is designed to demonstrate the feasibility of our
OnXpansion technology to enable precision medicine workflows in a way that is user-friendly/automated, robust,
and faithfully represents both the morphological, immunological, and molecular profile of the original tumor
sample and subsequent clinical response. In the Phase II portion of the proposed SBIR, we will further streamline
and deeply characterize OnXpansions utility to directly provide a closed, automated process for the
manufacturing of patient models at scale and derisk it's utilization as an immunocompetent model platform for
therapeutic screening of patient responses within academic hospital cores and companies offering personalized
drug screening assays.
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