OVV-01 / Joint Biosci, Beijing Boren Hospital - LARVOL DELTA

A Study of the Safety and Efficacy of the Intravenous and Intratumoral Injection of OVV-01 in Patients With Advanced Solid Tumours. (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Joint Biosciences Ltd.

New P1 trial • Breast Cancer • Colorectal Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • BRAF • HER-2 • KRAS • MSI

OVV-01 Intravenous and Intratumoral Injection Combined With AK112 for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P1 trial • Breast Cancer • Colorectal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

OVV-01 Injection Combined With AK112 Injection for the Treatment of Patients With Advanced Soft Tissue Sarcoma (STS) (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

New P2 trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

A Single-Arm, Open-Label Phase II Clinical Study to Evaluate the Safety and Efficacy of OVV-01 Injection in Patients with Advanced Soft Tissue Sarcoma (ChiCTR) - P=N/A | N=20 | Sponsor: Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital

New trial • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Mechanism of action of over-expressing NY-ESO-1 in vesicular stomatitis virus and its combination therapy with NY-ESO-1 TCR-T. (PubMed, Front Immunol) - "Our findings demonstrate that OVV-01 not only possesses potent direct oncolytic activity but also enhances the efficacy of adoptive T cell therapy by improving antigen presentation and T cell activation. This dual mechanism provides a rationale for using OVV-01 in combination immunotherapy strategies targeting solid tumors."

IO biomarker • Journal • Infectious Disease • Oncology • Solid Tumor • CD4 • CTAG1B

Phase 1, open-label, multicenter, dose escalation safety and tolerability study of oncolytic virus OVV-01 in advanced solid tumors. (PubMed, J Immunother Cancer) - P1 | "The intratumor injection of OVV-01 was safe and well-tolerated in patients with advanced solid tumors. A significant response was observed in patients with STS."

Clinical • Journal • P1 data • Genito-urinary Cancer • Oncology • Penile Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CTAG1B

A SINGLE-ARM, OPEN-LABEL CLINICAL STUDY OF OVV-01 ONCOLYTIC VIRUS INJECTION AS MONOTHERAPY OR IN COMBINATION WITH IMMUNE CHECKPOINT INHIBITORS FOR ADVANCED SOLID TUMOR PATIENTS (CTOS 2024) - "Oncolytic virus has a certain therapeutic effect on bone and soft tissue sarcoma, but more clinical data are still lacking. According to the current results, oncolytic virus therapy can be clinically beneficial for patients with bone and soft tissue tumors."

Checkpoint inhibition • Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • Oncolytic virus • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

VSV oncolytic virus OVV-01 for the treatment of advanced soft tissue sarcoma (CSCO 2024) - No abstract available

Metastases • Oncolytic virus • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Heyuan Biotech warmly congratulates Rongrui Pharmaceutical’s first oncolytic virus OVV-01 on obtaining the dual IND license of United States FDA [Google translation] (bydrug.pharmcube.com) - "On September 25, 2024, Shanghai Rongrui Pharm...a partner of Heyuan Biologics, announced that its self-developed oncolytic virus class I new drug OVV-01 vesicular stomatitis virus injection has been granted phase II and phase I clinical trial (IND) approval by the United States Food and Drug Administration (FDA), becoming the first oncolytic virus product in China to obtain two approvals from the United States FDA IND...Heyuan Biotech warmly congratulates its partners on this important milestone....'At present, we are actively promoting the registration and application of OVV-01 in China.'"

IND • New P1 trial • New P2 trial • Oncology • Solid Tumor

A phase I, open-label, multicenter, dose escalation safety and tolerability study of oncolytic virus OVV-01 in advanced solid tumors (ESMO 2024) - P1 | "The intratumor injection of OVV-01 was safe and well-tolerated in patients with advanced solid tumors, with no evidence of viral shedding. The efficacy of OVV-01 at dose levels higher than 3.0×109 PFU was encouraging; A significant response was observed in patients with STS."

Clinical • IO biomarker • Metastases • Oncolytic virus • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CTAG1B

Oncolytic Virus (OVV-01) Injection in the Treatment of Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: North China Petroleum Bureau General Hospital | Trial primary completion date: Feb 2023 ➔ Oct 2023

Checkpoint inhibition • Metastases • Oncolytic virus • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Immune Modulation • Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study of OVV-01 Injection in Combination With IBR900 Cell Injection in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1 | N=2 | Terminated | Sponsor: Beijing Boren Hospital | N=12 ➔ 2 | Trial completion date: Mar 2023 ➔ Aug 2022 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2022 ➔ Aug 2022; Research and development strategy adjustment

Combination therapy • Enrollment change • Oncolytic virus • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Lymphoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck