LX101 / Innostellar Biotherap - LARVOL DELTA

Safety and Tolerability of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Innostellar Biotherapeutics Co.,Ltd | Phase classification: P1/2 ➔ P1

Phase classification • Gene Therapies • Inherited Retinal Dystrophy

STAR: Efficacy and Safety of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations (clinicaltrials.gov) - P3 | N=30 | Active, not recruiting | Sponsor: Innostellar Biotherapeutics Co.,Ltd

New P3 trial • Gene Therapies • Inherited Retinal Dystrophy

Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy (clinicaltrials.gov) - P1/2 | N=9 | Active, not recruiting | Sponsor: Innostellar Biotherapeutics Co.,Ltd | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2024 ➔ Feb 2025

Enrollment closed • Trial primary completion date • Inherited Retinal Dystrophy

LX-101, a novel payload bearing IGF1-methotrexate conjugate, shows anti-inflammatory and anti-fibrotic effects in thyroid eye disease (ARVO 2025) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Ocular Inflammation • Ophthalmology • CCL11 • CXCL8 • IGF1 • IGF1R • IL13 • IL6 • POSTN

LX-101, a novel, clinical stage, payload-bearing, IGF-1R targeted therapy, has potent preclinical anti-tumor activity against sarcomas and other IGF-related cancers (Sarcoma-RC 2024) - "Background: LX-101, a next-generation, targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R), consists of a proprietary optimized IGF-1 variant coupled to a cytotoxic methotrexate payload...Background: LX-101, a next-generation, targeted therapy directed to the insulin-like growth factor 1 receptor (IGF-1R), consists of a proprietary optimized IGF-1 variant coupled to a cytotoxic methotrexate payload... These results demonstrate that LX-101 has potent preclinical anti-tumor activity against sarcoma and other rare cancer cells with well-established ties to the IGF-1R pathway, including those with different oncogenic gene fusions. These data support the clinical development of LX-101 in IGF-1R-related sarcomas and other rare cancers. Clinical trials are planned."

Preclinical • Adrenal Cortex Carcinoma • Ewing Sarcoma • Genito-urinary Cancer • Oncology • Osteosarcoma • Rhabdomyosarcoma • Sarcoma • Solid Tumor • EWSR1 • FLI1 • PAX3

Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy (clinicaltrials.gov) - P1/2 | N=9 | Recruiting | Sponsor: Innostellar Biotherapeutics Co.,Ltd

New P1/2 trial • Inherited Retinal Dystrophy

Safety and Tolerability of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations (clinicaltrials.gov) - P1/2 | N=9 | Active, not recruiting | Sponsor: Innostellar Biotherapeutics Co.,Ltd

Gene therapy • New P1/2 trial • Gene Therapies • Inherited Retinal Dystrophy