BSI-082 / Biosion - LARVOL DELTA

Biosion Announces First Patient Dosed in Investigator-Initiated Phase 1 Trial of BSI-082, a Next-Generation Anti-SIRPα Monoclonal Antibody for Advanced Solid Tumors (PRNewswire) - "The study is sponsored by and being conducted at the Mays Cancer Center, a National Cancer Institute (NCI)-designated Cancer Center and part of The University of Texas at San Antonio's Health Science Center....The Phase 1a/1b study is an open-label, dose-escalation and dose-expansion trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BSI-082 in patients with locally advanced or metastatic solid tumors."

Trial status • Solid Tumor

Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=57 | Not yet recruiting | Sponsor: Lei Zheng | Initiation date: Aug 2025 ➔ Jan 2026

Monotherapy • Trial initiation date • Solid Tumor

Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=57 | Not yet recruiting | Sponsor: Lei Zheng

Monotherapy • New P1 trial • Solid Tumor

Biosion Announces FDA Clearance of IND Application for BSI-082, a Novel Anti-SIRPα Monoclonal Antibody (PRNewswire) - "Biosion USA, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BSI-082, a novel anti-SIRPα monoclonal antibody (mAb) candidate."

IND • Hematological Malignancies • Oncology • Solid Tumor

BSI-082, a fully human anti-SIRPα antibody with both high specificity and broad coverage of SIRPα variant populations (AACR 2022) - "BSI-082 exhibits best-in-class biophysical properties, SIRPα specificity, broad SIRPα variant binding and superior functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies."

Clinical • Oncology • CD47 • SIRPA