mOTS-412 / Bionoxx - LARVOL DELTA

A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Bionoxx Inc. | Initiation date: Dec 2025 ➔ Jan 2027

IO biomarker • Trial initiation date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • ALK • BRAF • EGFR • MSI • PD-L1

A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (South Korea) (clinicaltrials.gov) - P1 | N=27 | Recruiting | Sponsor: Bionoxx Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2025 ➔ Mar 2026

Enrollment open • IO biomarker • Trial initiation date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • ALK • BRAF • EGFR • MSI • PD-L1

A Single-volunteer Study of Immune Response Following OTS-412 Vaccinia Virus Systemic Injection(Self-experiment) (clinicaltrials.gov) - P1 | N=1 | Completed | Sponsor: Bionoxx Inc.

New P1 trial

A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (South Korea) (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Bionoxx Inc.

IO biomarker • New P1 trial • Solid Tumor • PD-L1

A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Bionoxx Inc.

IO biomarker • New P1 trial • Solid Tumor • PD-L1

Bionoxx to Highlight Innovative Strategy for Addressing Immune-Related Diseases at 2024 BIO International Conference (PRNewswire) - "Bionoxx Inc...announced today it will unveil its novel immunomodulatory technology at the upcoming 2024 BIO International Convention...Bionoxx has already received clearance of an Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) to initiate a first-in-human clinical study of mOTS-412 or mOTS-412/anti-PD-L1 combination in participants with immune checkpoint inhibitor-resistant solid tumors. The trial is expected to begin in the latter half of 2024 in the United States."

IND • New P1 trial • Oncology • Solid Tumor