ISM041-141b / Insilico Medicine - LARVOL DELTA

Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: InSilico Medicine Hong Kong Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Mesothelioma • Oncology • Solid Tumor

Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors (clinicaltrials.gov) - P1 | N=82 | Not yet recruiting | Sponsor: InSilico Medicine Hong Kong Limited

Metastases • New P1 trial • Mesothelioma • Oncology • Solid Tumor

Insilico Medicine received IND approval and orphan drug designation from FDA for ISM6331, an AI-designed TEAD inhibitor targeting solid tumors and mesothelioma (Eurekalert) - "Insilico Medicine...announced ISM6331, potential best-in-class pan-TEAD inhibitor, has received the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance for the treatment of mesothelioma, following the grant of Orphan Drug Designation (ODD) in June 2024."

IND • New trial • Orphan drug • Mesothelioma • Oncology • Solid Tumor

ISM6331, a novel and potent pan-TEAD inhibitor, exhibits strong anti-tumor activity in preclinical models of Hippo pathway-dysregulated cancers (AACR 2024) - "The Hippo-YAP/TAZ-TEAD signaling pathway plays critical roles in tumorigenesis and tumor progression. In addition, ISM6331 showed excellent pharmacokinetic properties in multiple preclinical species and was well-tolerated in GLP-toxicity studies. In summary, ISM6331 has promising potential to treat Hippo pathway-dysregulated tumors as monotherapy as well as in combination with targeted therapies."

Preclinical • Mesothelioma • Oncology • Solid Tumor • KRAS • LATS1 • TEAD1