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Company

History & Achievement

Company History & Achievement
2025
  • Expanded Global Patent Protection – ONX-1006 secured patent protection in South Korea (March) and the United States (September), further strengthening Onselex’s intellectual property portfolio across Asia, Europe, and North America
  • Next-Generation Oncology Nanomedicine – ONX-1006 demonstrated substantial preclinical advantages in efficacy, safety, and sustained treatment capability compared with conventional paclitaxel-based therapy
  • Demonstrated Treatment Advantage – ONX-1006 achieved significantly greater tumor reduction and the highest level of tumor-cell apoptosis compared with Abraxane in preclinical studies, while its repeat-dose safety profile supports sustained, continuous treatment beyond the dosing limitations of conventional paclitaxel therapy
  • Advanced Toward Human Clinical Trials – Progressed preparations for Phase I/IIa clinical evaluation of ONX-1006 in Stage IV pancreatic cancer in Argentina, with a clinical development goal of achieving a 70% one-year survival rate
  • Expanded Global Clinical Partnerships – Advanced collaborations with leading cancer researchers and clinical teams to support the clinical development of ONX-1006
2024
  • Expanded Leadership Team – Onselex appointed a CBO/CFO, Chief Patent Officer, COO, and Chief Scientific Advisor to strengthen corporate, intellectual property, operational, and scientific leadership
  • Expanded Global Patent Protection – ONX-1006 secured additional patent protection in Japan and Europe, further strengthening Onselex’s global intellectual property portfolio
  • Advanced Clinical Development – Onselex progressed preparations to initiate human clinical evaluation of ONX-1006 in Argentina for Stage IV pancreatic cancer
  • Established Clinical Development Goal – Onselex set a target of achieving a 70% one-year survival rate in Stage IV pancreatic cancer patients treated with ONX-1006
2023
  • Oct. 06, 2023 ONX-1006 completed a comprehensive Good Laboratory Practice (GLP) toxicology program comprising more than 30 studies and approximately 4,000 pages of reports, demonstrating a highly favorable preclinical safety profile
  • ONX-1006 established a high No Observed Adverse Effect Level (NOAEL) across GLP studies in rats and beagle dogs, including the pivotal 13-week repeat-dose IV toxicity study with once-weekly administration for 13 consecutive weeks, followed by a 4-week recovery period and toxicokinetic evaluation
  • The GLP NOAEL findings demonstrated a substantial preclinical safety margin and support repeated, continuous administration of ONX-1006 for clinical development
2022
  • Oct. 12, 2022 Professor Si-Young Song, Distinguished Professor at Yonsei University College of Medicine, joined the Onselex Clinical Advisory Board (CAB)
  • Oct. 06, 2022 Professor Ho-Soon Choi of Hanyang University Medical Center joined the Onselex Clinical Advisory Board (CAB)
  • July 04, 2022 ONX-1006 PANC-1 Xenograft PK Study: Confirmed substantially higher PTX accumulation in tumor tissue than in plasma
  • Mar. 30, 2022 ONX-1006 GLP Toxicology Study (Single IV Administration, Beagles): Beagles remained in normal condition following administration of ONX-1006 at 25 mg/kg PTX equivalent, approximately 3× the lethal dose of paclitaxel
  • Mar. 03, 2022 ONX-1006 AsPC-1 Pancreatic Cancer Xenograft Study: Demonstrated statistically significant antitumor efficacy
2021
  • Dec. 14, 2021 ONX-1006 GLP Toxicology Study (IV, Rats): Rats remained in normal condition following ONX-1006 administration at approximately 50× the lethal dose of paclitaxel
  • Oct. 06, 2021 Completed development of ONX-2006 oral anticancer drug for stomach and colon cancer
  • Sep. 27, 2021 ONX-1006 AsPC-1 Pancreatic Cancer Xenograft Study: Outstanding efficacy demonstrated in the 3rd study
  • Aug. 10, 2021 Initiated 3rd ONX-1006 xenograft efficacy study with Dt&C
  • Mar. 30, 2021 Completed entry into the national phase of the PCT international patent application
2020
  • Aug. 31, 2020 Signed a formal agreement for ONX-1006 preclinical studies
  • Aug. 27, 2020 Signed an agreement for ONX-1006 animal efficacy studies
  • Aug. 25, 2020 Raised KRW 2.58 billion in investment capital
  • July 13, 2020 Signed a nanomedicine licensing agreement with Onselex Pharma
  • July 10, 2020 Completed kilogram-scale production of GLP-grade ONX-1006
  • July 01, 2020 Signed a technology transfer agreement for the Programmed Drug-Loaded Nanoparticle Technology
  • Mar. 19, 2020 Established Onselex Inc. in South Korea with KRW 1.6 billion in founding capital
2018
  • Aug. 01, 2018 Established Onselex Pharmaceuticals Inc. in the United States