History
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2024 Q4 ~ Ongoing & Planned
- ㆍ(Planned) FDA INTERACTED meeting for STUP-002 (Feb 2025)
- ㆍ(Planned) FDA Pre-IND meeting for STUP-001 (Feb 2025)
- ㆍ(Ongoing) Clinical Trials of STUP-001 (Safety & Exploratory efficacy) (Nov 2024)
- ㆍ(Ongoing) Development of Long-term Follow-Up Study Protocol & ICF (Oct 2024)
- ㆍ(Ongoing) GCLP-compliant Method Validation for Vector Genome Shedding (Sep 2024)
- ㆍ(Ongoing) Clinical Trials of STUP-001 (Safety & Exploratory efficacy) (Nov 2024)
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2024 Q2
- ㆍSelected for IP-R&D Strategic Support Project
- ㆍSubmission of IRB to the clinical site (Severance Hospital)
- ㆍEvaluation of the Safety and Efficacy of the Canine Cognitive Dysfunction Treatment (Report no. HMR-SCP-01)
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2024 Q1
- ㆍLead Optimization of STUP-002
- ㆍDrug Repositioning Study of STUP-001
- ㆍGlobal Biopharma Communication Start on STUP-001 and Cell Resetting Technology
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2023 Q4
- ㆍSTUP-001 intellectual property registration (Domestic registration; No. 10-259XXXX)
- ㆍSTUP-002 intellectual property application (Domestic filing; 10-2023-012XXXX)
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2023 Q3
- ㆍComplete GMP-compliant STUP-001 manufacturing
- ㆍComplete development of CMC(Chemistry, Manufacturing and Control) documentation
- ㆍMOU contract for medium-sized animal clnical study (Veterinary hospital)
- ㆍSTUP-001 intellectual property application (Domestic filing; 10-2023-008XXXX)
- ㆍSTUP-001 intellectual property application (PCT filing; PCT/KR2023/00XXXX)
- ㆍSTUP-002 intellectual property application (Domestic filing; 10-2023-011XXXX)
- ㆍSubmission of IND to the MFDS (Ministry of Food and Drug Safety)
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2023 Q2
- ㆍResearch contract for NHP(Hon-Human Primate) efficacy study
- ㆍSelected for Infectious Disease Control System Enhancement R&D
- ㆍSelected for IP-R&D Strategic Support Project
- ㆍPaper in SCI journal Nanomaterials (IF:5.3)
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2023 Q1
- ㆍCRO contract for clinical protocol developmet (STUP-001)
- ㆍCompletion of clinical protocol development (STUP-001)
- ㆍSubmission of IND to the MOHW (Ministry of Health and Welfare)
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2022 Q4
- ㆍPublished SCI-journal review paper about spinal cord injury therapy based on Direct Lineage Reprogramming Technology
- ㆍResearch contract with Molim INC for immunogenicity test
- ㆍResearch contract with H-Bio INC
- ㆍResearch contract with Yonsei University
Industry-Academic Cooperation Foundation - ㆍSelected for National Advanced Regenerative Medicine Project
- ㆍCompleted GLP-compliant non-clinical toxicity evaluation
(Non-Toxicity Determined)
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2022 Q3
- ㆍGMP-grade AAV production with VectorBuilder
- ㆍPaper in world renowned journal Acta Biomaterialia (IF : 10.66)
- ㆍSelected for National New Drug Development Project
- ㆍVenture Certification
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2022 Q2
- ㆍFamily sales funding contract
- ㆍResearch contract with KIST
(Korea Institute of Science and Technology) - ㆍResearch contract with Kyungki University
(Biodistribution for toxicity evaluation) - ㆍResearch contract with Chemon INC
(Non-clinical toxicity evaluation)
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2022 Q1
- ㆍEstablishment of Research Institute
- ㆍCertification of ISO 9001/14001
- ㆍRegistration of BSL-2 (Central laboratory facility)
- ㆍRegistration of ABSL-2 (Animal laboratory)
- ㆍPatent advisory contract with Patent Law-Firm IPLAY
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2021
- ㆍStand Up Therapeutics INC Established
- ㆍResearch Laboratory Open
2013- A Study on the Direct Lineage Reprogramming(DLR)
of induced neurons(iNs) for the neurodegenerative disease gene therapy