Clinical study
Our main priority is to develop the method of permanent cure for incurable neuro-disease using our smart gene therapy technology. The current clinical program focuses on the development of innovative products targeting Spinal Cord Injury. Stand Up Therapeutics has developed STUP-001 in cooperation with university research institutes, national research institutes, and major hospital.
In Progress
Complete
STUP-001 Non-Clinical Study
• GLP-compliant general-toxicity study (22-MA-0875)
• GLP-compliant Safety Pharmacology (22-MA-0875)
• Analytical method validation for Biodistribution (22-STU-R003)
• Biodistribution study (22-STU-R004)
• Cell-mediated Immunogenicity study (22-STU-R005)
• Primary Efficacy Study (7 individual Report)
• Secondary Efficacy Study (3 individual Report)
• MOA Study (3 individual Report)
STUP-001 Manufacturing Process
• Manufacturing Technology Transfer for AAV2 Packaging (Report no. 22-VB-T01)
• Manufacturing Technology Transfer for Downstream Process 1 (Report no. 22-VB-T02)
• Manufacturing Technology Transfer for Downstream Process 2 (Report no. 22-VB-T03)
• CMC summary Report for GMP-like STUP-001 (Report no. 220624GLA01)
• CMC documentation for GMP-compliant STUP-001 (CTD module 3)
• Stability Report for DS and DP (24-VB-S01, 24-VB-S02)
STUP-001 Clinical Study
• Protocol for IIT (STUP-001_PRT_V5.0)
• Investigator’s Brochure (IB-STU-001-01_V2.0)
• Informed Consent Form for IIT (STUP-001_ICF_V3.0)
Ongoing & Planned
• (4Q 2024) First Patient enrollment for STUP-001 clinical study
• (4Q 2024) Analytical Method Validation for STUP-001 Genome Shedding (24-MT-01)
• (4Q 2024) Long-Term Follow-Up Study after Administration of STUP-001 (24-PRT-01)
STUP-001 Non-Clinical Study
• GLP-compliant general-toxicity study (22-MA-0875)
• GLP-compliant Safety Pharmacology (22-MA-0875)
• Analytical method validation for Biodistribution (22-STU-R003)
• Biodistribution study (22-STU-R004)
• Cell-mediated Immunogenicity study (22-STU-R005)
• Primary Efficacy Study (7 individual Report)
• Secondary Efficacy Study (3 individual Report)
• MOA Study (3 individual Report)
STUP-001 Manufacturing Process
• Manufacturing Technology Transfer for AAV2 Packaging (Report no. 22-VB-T01)
• Manufacturing Technology Transfer for Downstream Process 1 (Report no. 22-VB-T02)
• Manufacturing Technology Transfer for Downstream Process 2 (Report no. 22-VB-T03)
• CMC summary Report for GMP-like STUP-001 (Report no. 220624GLA01)
• CMC documentation for GMP-compliant STUP-001 (CTD module 3)
• Stability Report for DS and DP (24-VB-S01, 24-VB-S02)
STUP-001 Clinical Study
• Protocol for IIT (STUP-001_PRT_V5.0)
• Investigator’s Brochure (IB-STU-001-01_V2.0)
• Informed Consent Form for IIT (STUP-001_ICF_V3.0)
Ongoing & Planned
• (4Q 2024) First Patient enrollment for STUP-001 clinical study
• (4Q 2024) Analytical Method Validation for STUP-001 Genome Shedding (24-MT-01)
• (4Q 2024) Long-Term Follow-Up Study after Administration of STUP-001 (24-PRT-01)