Stand Up Therapeutics

History

  • 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)
  • 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)
  • 2024 Q1
    • ㆍLead Optimization of STUP-002
    • ㆍDrug Repositioning Study of STUP-001
    • ㆍGlobal Biopharma Communication Start on STUP-001 and               Cell Resetting Technology
  • 2023 Q4
    • ㆍSTUP-001 intellectual property registration (Domestic registration; No. 10-259XXXX)
    • ㆍSTUP-002 intellectual property application (Domestic filing; 10-2023-012XXXX)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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
  • 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)
  • 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
  • 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