LINK BIOSYSTEMS INC.

813-766-7280

kacey.bouchard@linkbiosystems.com

KACEY RONALDSON

Self-Certified Small Disadvantaged Business

P2661752

2023-09-15

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Department of Health and Human Services

EFFICIENT SCALE-UP OF IPS CELLS FOR AUTOLOGOUS CELL THERAPY WORKFLOW - PROJECT SUMMARY/ABSTRACT CELL EXPANSION IS A CRITICAL STEP FOR CELL THERAPY, HINDERED BY EXPENSIVE AND COMPLEX BIOREACTOR REQUIREMENTS TO YIELD SUFFICIENT CELL NUMBERS FOR ADEQUATE DOSING AND REQUIRING EXPENSIVE REGENTS TO ENHANCE FUNCTIONALITY FOR INCREASED CLINICAL SUCCESS. TO SUPPORT THE USE OF PATIENT CELLS WITHIN THE CELL THERAPY WORKFLOW, THERE IS A NEED FOR BIOREACTORS DESIGNED FOR EXPANDING PATIENT CELLS FROM AN INITIAL IPS CLONAL POPULATION TO CLINICALLY RELEVANT CELL DOSES. THESE REACTORS MUST ALSO BE SUITABLE FOR CGMP PROCESSES AND ECONOMICALLY EFFICIENT TO ENABLE THEIR UTILITY WITHIN THE HEALTHCARE SYSTEM. OVERALL, THERE IS A NEED FOR CLINICALLY RELEVANT CELL EXPANSION TECHNOLOGIES THAT ARE ROBUST AND EFFICIENT ENOUGH TO ENABLE THE REALIZATION OF AUTOLOGOUS CELL THERAPY WORKFLOWS AS A VIABLE TREATMENT OPTION FOR ALL. THUS, THE UNMET NEED WE WILL ADDRESS IS PROVIDING A BIOREACTOR-BASED WORKFLOW FOR THE EFFICIENT TRANSLATION OF PATIENT CELLS INTO HIGH-QUALITY IPS CELL BASED THERAPEUTICS IN A PATIENT-SPECIFIC MANNER – BENEFITING DRUG DEVELOPERS, PATIENTS, CLINICIANS, AND THE HEALTHCARE ECONOMY. OUR UNIVERSAL APPROACH TO CELL EXPANSION (ONXPANSION) USES A DEFINED SERUM-FREE MEDIA AND RELIES ON CONTROLLED AGGREGATION FOR ENHANCED PARACRINE SIGNALING AND CELL-CELL CONTACT, ENHANCED NUTRIENT DELIVERY VIA LOW-SHEAR PERFUSION, AND ORGANOTYPIC TISSUE NICHES TO GENERATE THOUSANDS OF IDENTICAL SPHEROID TISSUES THAT CAN BE FURTHER SCALED TO YIELD ADEQUATE CELL NUMBERS FOR CELL THERAPY AT BOTH REDUCED COSTS AND MANUAL LABOR. OUR APPROACH TO TRANSLATING THIS TECHNOLOGY CENTER AROUND DE-RISKING ITS UTILITY FOR PRECISION MEDICINE AND INCREASING ITS SUITABILITY AND HANDLING WITHIN THE INTENDED CUSTOMER WORKFLOWS. OUR BIOREACTOR PRODUCTS ARE EFFICIENT (COST, TIME, LABOR), EASY TO USE, AUTOMATED, RELIABLE, ROBUST, PHYSIOLOGICALLY RELEVANT, AND CLINICALLY PREDICTIVE. THE LARGE UNMET NEED AND LOW BARRIER FOR ENTRY POSITIONS LINK FAVORABLY AGAINST COMPETITORS. OVERALL, LINK’S PRODUCTS ARE DESIGNED TO ENABLE A RELIABLE AND ROBUST PRECISION MEDICINE WORKFLOW THAT IS EFFICIENT AND OF HIGH BIOLOGICAL FIDELITY, THEREBY ENABLING A FUTURE WHERE CELL THERAPY IS MORE ACCESSIBLE TO THE PATIENT, VIA DECREASED COSTS, AND THE PROVIDER, VIA SIMPLIFIED WORKFLOWS.

275627.00

0.00

0.00

2023-09-05

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Department of Health and Human Services

EFFICIENT DIFFERENTIATION, SCALE-UP, AND MATURATION OF IPS DERIVED CARDIOMYOCYTES - PROJECT SUMMARY/ABSTRACT CELL EXPANSION IS A CRITICAL STEP FOR CELL THERAPY, HINDERED BY EXPENSIVE AND COMPLEX BIOREACTOR REQUIREMENTS TO YIELD SUFFICIENT CELL NUMBERS FOR ADEQUATE DOSING AND REQUIRING EXPENSIVE REGENTS TO ENHANCE FUNCTIONALITY FOR INCREASED CLINICAL SUCCESS. SIMILARLY, IN-VITRO MODELS OF CARDIAC DISEASE USING INDUCED PLURIPOTENT STEM CELL DERIVED CARDIOMYOCYTES (IPS-CM) ARE OF CRITICAL IMPORTANCE TO UNDERSTANDING CARDIAC BIOLOGY AND DISEASE IN THE HUMAN SETTING. HOWEVER, INEFFICIENT DIFFERENTIATIONS HINDER THE ROBUST TRANSLATION OF THESE MODELS FROM THE BENCH TO CLINICALLY USEFUL METRICS. SIMILARLY, IPS-CMS ARE INHERENTLY IMMATURE AND REPRESENT FETAL LIKE PHENOTOYPES MORE THAN THEIR ADULT COUNTERPARTS OF MORE RELEVANCE FOR CLINICAL UTILITY. THUS, THERE IS A NEED FOR THE RELIABLE PRODUCTION OF IPS-CMS OF HIGH QUALITY, YIELD, AND MATURITY. TO ADDRESS THIS, LINK PROVIDES LOW-SHEAR PUMPLESS PERFUSION BIOREACTORS CONTATINING ORGANOTYPIC NICHES FOR THE BULK CULTURE OF CELLS IN CONTROLLABLE 3D AGGREGATES FOR ENHANCED DELIVERY OF NUTRIENTS, ENHANCED EFFICIENCY OF DIRECTED DIFFERENTIATIONS, AND INCREASED VIABILITY AND YEILD DUE TO EFFICIENT GAS AND NUTRIENT EXCHANGE. THESE BIOREACTORS REQUIRE SIGNIFICANTLY LESS MEDIA THAN SIMILAR BIOREACTORS AND SUBSTANTIALLY LESS HAND-ON CULTURE TIME THAN CURRENT MANUAL WORKFLOWS. OUR DEVICES ARE COST EFFICIENT AND SIMPLE TO USE, DEMOCRATIZING PATIENT MODELING AND CELL THERAPY FOR BOTH PATIENTS, RESEARCHERS AND PROVIDERS. THE INCREASED EFFICIENCY OF OUR DEVELOPED DEVICE ENABLES AN INCREASE IN THE PATIENT POOL BY IMPROVING PATIENT ACCESS, AVAILABILITY, AND APPLICABILITY TO MORE DISEASE SUBTYPES.

275396.00

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2025-04-09

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Department of Health and Human Services

CELL EXPANSION BIOREACTORS FOR ASSAY-READY IMMUNOCOMPETENT PATIENT MODELS - PROJECT SUMMARY/ABSTRACT ALTHOUGH CANCER IS A LEADING CAUSE OF DEATH GLOBALLY, ONCOLOGY DRUGS HAVE THE LOWEST SUCCESS RATES, COST THE MOST TO DEVELOP, AND CONSTANTLY SHOW PROMISING RESULTS IN ANIMALS AND THEN FAIL TO WORK IN PATIENTS. THUS, THERE IS A NEED FOR MODELS THAT FACILITATE UNDERSTANDING OF HOW A DRUG WILL WORK IN HUMANS AND FOR SPECIFIC PATIENT POPULATIONS. THE AVAILABILITY OF HUMAN TUMOR SAMPLES WILL FURTHER FACILITATE ENHANCED PRECLINICAL SCREENING, WHERE LONG TIMELINES (>10 YEARS), HIGH COSTS ($2.6B), AND LOW SUCCESS RATES (1/5,000) PLAGUE THE DEVELOPMENT OF NEW DRUGS. LINK BIOSYSTEMS PROVIDES A UNIVERSAL APPROACH TO TUMOR CELL EXPANSION VIA A CUSTOM BIOREACTOR PRODUCT THAT USES A DEFINED SERUM-FREE MEDIA AND RELIES ON CONTROLLED AGGREGATION FOR ENHANCED PARACRINE SIGNALING AND CELL-CELL CONTACT, ENHANCED NUTRIENT DELIVERY VIA LOW-SHEAR PERFUSION, AND ORGANOTYPIC TISSUE NICHES TO GENERATE THOUSANDS OF IDENTICAL IMMUNOCOMPETENT TUMOROID TISSUES THAT CAN BE FURTHER SCALED AS NEEDED. THIS APPROACH WOULD ENABLE THE ESTABLISHMENT OF ROBUST TUMOR MODELS FOR EARLY AND LATE STAGE CANCERS, RARE CANCERS, AND PREVIOUSLY BIOBANKED SAMPLES AT QUANTITIES SUITABLE FOR SCREENING LARGE DRUG PANELS – INCLUDING IMMUNOTHERAPIES, BIOLOGICS, AND DRUG-DRUG COMBINATIONS, TO FIND AN OPTIMALLY EFFECTIVE DRUG REGIMEN FOR THE SPECIFIC PATIENT. ADDITIONALLY, THE ABILITY TO GENERATE QUALITY-CONTROLLED PATIENT CELLS AT SCALE WILL ENABLE THE ESTABLISHMENT OF PATIENT TUMOR BIOBANKS AND SUBSEQUENT PERSONALIZED DRUG SCREENING FOR OPTIMAL TREATMENT GUIDANCE AND TO OVERCOME DRUG RESISTANT PHENOTYPES. TO THIS END, WE ARE SIMILARLY EVALUATING OUR BIOREACTORS VERSATILE 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.

911110.00

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0.00

2023-09-12

View on USAspending

Department of Health and Human Services

CELL EXPANSION BIOREACTORS FOR ASSAY-READY IMMUNOCOMPETENT PATIENT MODELS - PROJECT SUMMARY/ABSTRACT ALTHOUGH CANCER IS A LEADING CAUSE OF DEATH GLOBALLY, ONCOLOGY DRUGS HAVE THE LOWEST SUCCESS RATES, COST THE MOST TO DEVELOP, AND CONSTANTLY SHOW PROMISING RESULTS IN ANIMALS AND THEN FAIL TO WORK IN PATIENTS. THUS, THERE IS A NEED FOR MODELS THAT FACILITATE UNDERSTANDING OF HOW A DRUG WILL WORK IN HUMANS AND FOR SPECIFIC PATIENT POPULATIONS. THE AVAILABILITY OF HUMAN TUMOR SAMPLES WILL FURTHER FACILITATE ENHANCED PRECLINICAL SCREENING, WHERE LONG TIMELINES (>10 YEARS), HIGH COSTS ($2.6B), AND LOW SUCCESS RATES (1/5,000) PLAGUE THE DEVELOPMENT OF NEW DRUGS. LINK BIOSYSTEMS PROVIDES A UNIVERSAL APPROACH TO TUMOR CELL EXPANSION VIA A CUSTOM BIOREACTOR PRODUCT THAT USES A DEFINED SERUM-FREE MEDIA AND RELIES ON CONTROLLED AGGREGATION FOR ENHANCED PARACRINE SIGNALING AND CELL-CELL CONTACT, ENHANCED NUTRIENT DELIVERY VIA LOW-SHEAR PERFUSION, AND ORGANOTYPIC TISSUE NICHES TO GENERATE THOUSANDS OF IDENTICAL IMMUNOCOMPETENT TUMOROID TISSUES THAT CAN BE FURTHER SCALED AS NEEDED. THIS APPROACH WOULD ENABLE THE ESTABLISHMENT OF ROBUST TUMOR MODELS FOR EARLY AND LATE STAGE CANCERS, RARE CANCERS, AND PREVIOUSLY BIOBANKED SAMPLES AT QUANTITIES SUITABLE FOR SCREENING LARGE DRUG PANELS – INCLUDING IMMUNOTHERAPIES, BIOLOGICS, AND DRUG-DRUG COMBINATIONS, TO FIND AN OPTIMALLY EFFECTIVE DRUG REGIMEN FOR THE SPECIFIC PATIENT. ADDITIONALLY, THE ABILITY TO GENERATE QUALITY-CONTROLLED PATIENT CELLS AT SCALE WILL ENABLE THE ESTABLISHMENT OF PATIENT TUMOR BIOBANKS AND SUBSEQUENT PERSONALIZED DRUG SCREENING FOR OPTIMAL TREATMENT GUIDANCE AND TO OVERCOME DRUG RESISTANT PHENOTYPES. TO THIS END, WE ARE SIMILARLY EVALUATING OUR BIOREACTORS VERSATILE 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.

327767.00

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