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acrixolimab (YBL-006)
i
Other names: YBL-006, YBL 006, YBL006
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News alerts, weekly reports and conference planners
Company:
Y-Biologics
Drug class:
PD1 inhibitor
Related drugs:
1year
Safety and efficacy of YBL-006, a novel anti-PD-1 antibody, in advanced solid tumors including G3 NET/NEC: results from a phase 1/2A study (SITC 2023)
Y-biologics Inc would like to thank all the participating patients, dedicated clinical trial investigators and their team members who have helped to bring this novel therapy to the clinic. This research was supported by Korea Drug Development Fund funded by Ministry of Science and ICT, Ministry of Trade, Industry, and Energy, and Ministry of Health and Welfare (HN21C1391, Republic of Korea).
P1/2 data • Clinical • Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker • Metastases
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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TMB-H • MSI-H/dMMR
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Lunit SCOPE IO
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acrixolimab (YBL-006)
over1year
Derivation of Breast Cancer Patient Derived Human Induced Pluripotent Stem Cell Line (YBLi006-A) with FANC-BRCA Gene Mutations: A Resource for Precision & Personalized Medicine. (PubMed, Stem Cell Res)
We generated an iPSC line (YBLi006-A) from peripheral blood mononuclear cells (PBMCs) of a patient carrying a mutation in FANCIgene (NM_001376911.1, NM_001376910.1, NM_001113378.2; c.80G > T, c.257C > T, c.2225G > C; p.Gly27Val, p.Ala86Val, p.Cys742Ser) using non-integrating Sendai virus technology. This unique breast cancer patient-derived-iPSC line will be resourceful to analyze the entire coding sequence and splicing sites ofFANCIin high-risk familial breast cancer.
Preclinical • Journal • BRCA Biomarker
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BRCA (Breast cancer early onset) • FANCI (FA Complementation Group I)
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BRCA mutation • FANCI mutation
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acrixolimab (YBL-006)
2years
YBL006C101: Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=90, Active, not recruiting, Y Biologics Inc. | Recruiting --> Active, not recruiting | Phase classification: P1 --> P1/2 | Trial primary completion date: Sep 2022 --> Mar 2023
Enrollment closed • Phase classification • Trial primary completion date • Tumor mutational burden • Metastases
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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PD-L1 expression • TMB-H • MSI-H/dMMR • ALK translocation
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acrixolimab (YBL-006)
over2years
Safety and efficacy of YBL-006, an anti-PD-1 monoclonal antibody in advanced solid tumors: A phase I study. (ASCO 2022)
Interim analysis of phase I trial of YBL-006 shows a tolerable safety profile and clinical activity. Notable anti-tumor efficacy was observed in inflamed immune phenotype.
P1 data • Clinical • PD(L)-1 Biomarker • IO biomarker
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Lunit SCOPE IO
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acrixolimab (YBL-006)
3years
YBL006C101: Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=90, Recruiting, Y Biologics Inc. | Trial completion date: Sep 2022 --> May 2023
Clinical • Trial completion date
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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PD-L1 expression • TMB-H • MSI-H/dMMR • ALK translocation
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acrixolimab (YBL-006)
over3years
[VIRTUAL] Interim analysis of first-in-human phase 1 study to assess safety and efficacy of YBL-006, an anti-PD-1 antibody in advanced solid tumor with exploratory biomarker analysis of tumor mutational burden and artificial intelligence (AI)-powered spatial analysis of tumor-infiltrating lymphocytes. (ASCO 2021)
Interim analysis of phase I study showed that YBL-006 is well tolerated and preliminary biomarker analysis showed that the TMB, and intratumoral TIL infiltration are potentially related to the response to YBL-006.
Clinical • P1 data • Tumor Mutational Burden • Tumor-Infiltrating Lymphocyte • PD(L)-1 Biomarker • IO biomarker
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TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma)
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acrixolimab (YBL-006)
almost4years
Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=80, Recruiting, Y Biologics Inc. | Not yet recruiting --> Recruiting
Clinical • Enrollment open
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
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PD-L1 expression • EGFR mutation • MSI-H/dMMR • ALK translocation
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acrixolimab (YBL-006)
over4years
Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=80, Not yet recruiting, Y Biologics Inc.
Clinical • New P1 trial
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EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
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PD-L1 expression • EGFR mutation • MSI-H/dMMR • ALK translocation
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acrixolimab (YBL-006)
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