BS001 / Wuhan Binhui Biotech - LARVOL DELTA

OH2 Injection in Solid Tumors (clinicaltrials.gov) - P1/2 | N=44 | Completed | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Recruiting ➔ Completed | N=30 ➔ 44 | Trial completion date: Dec 2026 ➔ Jun 2026

Enrollment change • Trial completion • Trial completion date • Breast Cancer • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Herpes Simplex • Melanoma • Oncology • Solid Tumor • CSF2

OH2 Oncolytic Viral Therapy in Central Nervous System Tumors (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Recruiting ➔ Completed | N=28 ➔ 40

Enrollment change • Trial completion • Brain Cancer • CNS Tumor • Ependymoma • Glioblastoma • Oncology

Safety and preliminary efficacy of OH2 combined with BS006 sequential intratumoral injection in patients with advanced solid tumors: An open-label, dose-escalation phase Ib/II study. (ASCO 2026) - "Sequential intratumoral administration of OH2 and BS006 in heavily pre-treated patients is feasible and safe and results in reasonable DCR, with some patients achieving long-term clinical benefits. This study supports the clinical relevance of an HSV2-based platform combination of 2 oncolytic viruses encoding GM-CSF and T-cell redirected bispecific antibodies to warm up the cold TME. Further clinical research of the platform is warranted."

Clinical • Metastases • P1/2 data • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Leiomyosarcoma • Liver Cancer • Melanoma • Oncology • Pancreatic Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CSF2

A novel oncolytic herpes simplex virus type 2 induces polarization of tumor-associated macrophages and remodels the immune microenvironment in glioblastoma. (PubMed, Cancer Immunol Immunother) - P1/2 | "OH2 exerts antitumor activity in GBM through direct oncolysis and immune microenvironment modulation, highlighting its potential as an immunotherapeutic strategy."

Journal • Brain Cancer • Glioblastoma • Herpes Simplex • Oncology • Solid Tumor • STAT1

Oncolytic virus OH2 induces PD-L1 upregulation via NF-κB signaling and synergizes with anti-PD-L1 therapy in prostate cancer through a targeted extracellular vesicle delivery system. (PubMed, J Immunother Cancer) - "This study identifies a mechanism of OH2-induced PD-L1 expression in PCa and provides a versatile, targeted delivery platform that enables effective intravenous viro-immunotherapy, overcoming key translational barriers."

IO biomarker • Journal • Genito-urinary Cancer • Herpes Simplex • Oncology • Prostate Cancer • Solid Tumor • CD8

OH2 Injection in Combination With BS006 Injection for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd.

New P1/2 trial • Biliary Tract Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Melanoma • Solid Tumor

Escherichia coli Nissle 1917 outer membrane vesicles encapsulating oncolytic virus remodel tumor-associated macrophages and kill prostate cancer cells. (PubMed, J Control Release) - "We aimed to leverage the protective capacity and tumor-targeting properties of EcN-OMVs to enhance OH2 accumulation within tumors. Concurrently, both the EcN-OMVs and OH2 are anticipated to collaboratively remodel the immunosuppressive tumor microenvironment of prostate cancer, thereby enhancing overall immunotherapeutic efficacy."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Oncolytic herpes simplex virus 2 (OH2) induces M1 macrophage polarization and enhances anti-tumor immunity in glioblastoma (ESMO 2025) - "These findings support OH2 as a promising candidate for GBM immunotherapy. Legal entity responsible for the study The author."

IO biomarker • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD86 • IL10 • IL6 • MRC1 • TNFA

OH2 Injection in Solid Tumors (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Herpes Simplex • Melanoma • Oncology • Solid Tumor • CSF2

OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Binhui Biopharmaceutical Co., Ltd. | N=45 ➔ 4 | Trial completion date: Dec 2025 ➔ Oct 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jul 2025 ➔ Oct 2024; Strategy adjustment

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

OH2 oncolytic virus inhibits non-small-cell lung cancer metastasis via β-catenin pathway suppression. (PubMed, Commun Biol) - "Mechanistically, the OH2 tegument protein UL41 is identified as a critical factor that degrades β-catenin mRNA, thus inhibiting β-catenin nuclear transcriptional activity. These findings reveal a novel anti-metastatic mechanism of OH2 via disruption of the β-catenin/MMPs axis and support its potential as a therapeutic candidate for invasive NSCLC."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

OH2 Injection in Melanoma (clinicaltrials.gov) - P3 | N=340 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Mar 2026 ➔ Mar 2027 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

OH2 Oncolytic Viral Therapy in Central Nervous System Tumors (clinicaltrials.gov) - P1/2 | N=28 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Ependymoma • Glioblastoma

OH2 Injection in Combination With HX008 for Melanoma. (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Nov 2023 ➔ Nov 2025 | Trial primary completion date: Nov 2023 ➔ Nov 2025

Trial completion date • Trial primary completion date • Herpes Simplex • Melanoma • Oncology • Solid Tumor

The VP5 protein of the oncolytic virus OH2 regulates nectin-3 molecule to modulate tumor cell apoptosis. (PubMed, Virology) - "Through this, we identified nectin-3 as a differentially expressed gene associated with tumor cell killing induced by VP5 protein. Further studies on nectin-3 revealed that the structural protein VP5 of oncolytic virus OH2 regulates the expression of nectin-3 in tumor cells, thereby promoting or inhibiting tumor cell apoptosis."

IO biomarker • Journal • Herpes Simplex • Oncology • Solid Tumor

Phase Ib/II clinical trial of oncolytic virus intravesical irrigation for preventing recurrence after TURBT in patients with recurrent high-risk NMIBC. (ASCO-GU 2025) - P1/2 | "OH2 injection is independently developed domestically and is the first in China to be used for intravesical irrigation therapy for recurrent high-risk NMIBC, particularly in patients who have failed BCG therapy. According to our data, OH2 injection intravesical irrigation is safe. The long term efficacy deserves further research."

Clinical • Oncolytic virus • P1/2 data • Bladder Cancer • Genito-urinary Cancer

Oncolytic virus OH2 extends survival in patients with PD-1 pretreated melanoma: phase Ia/Ib trial results and biomarker insights. (PubMed, J Immunother Cancer) - P1/2, P3 | "OH2 oncolytic virotherapy exhibited a favorable safety profile without dose-limiting toxicities (DLTs) and demonstrated durable antitumor efficacy in patients with melanoma, especially in those who had progressed on anti-PD-1 treatment."

Biomarker • IO biomarker • Journal • P1 data • Genetic Disorders • Herpes Simplex • Melanoma • Oncology • Skin Cancer • Solid Tumor

Intratumoral oncolytic virus OH2 injection in patients with locally advanced or metastatic sarcoma: a phase 1/2 trial. (PubMed, J Immunother Cancer) - "Intratumoral injection of oncolytic virus OH2 is well tolerable in patients with sarcoma. Further investigation of OH2 with HX008 in select sarcoma subtypes is warranted."

Journal • P1/2 data • Herpes Simplex • Oncology • Sarcoma • Solid Tumor • CSF2

OH2 Injection in Solid Tumors (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Cervical Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Herpes Simplex • Melanoma • Oncology • Solid Tumor

OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Jan 2025 ➔ Jan 2026 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Metastases • Oncolytic virus • Trial completion date • Trial primary completion date • Hepatology • Liver Cancer • Oncology • Solid Tumor

OH2 Oncolytic Viral Therapy in Solid Tumors (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Aug 2024 ➔ Aug 2025 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Oncolytic virus • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Gastrointestinal Disorder • Herpes Simplex • Oncology • Solid Tumor

OH2 Administered by Intratumoral Injection (clinicaltrials.gov) - P1 | N=29 | Not yet recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Jan 2026 ➔ Jan 2028 | Trial primary completion date: Jul 2025 ➔ Jul 2027

Metastases • Oncolytic virus • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Melanoma • Oncology • Solid Tumor

OH2 Oncolytic Viral Therapy in Advanced Bladder Cancer (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jul 2024 ➔ Jul 2025

Metastases • Oncolytic virus • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Oct 2024 ➔ Oct 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Oncolytic virus • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Autologous, oncolytic virus-activated killer (VAK) cell therapy to treat malignant pleural and peritoneal effusions. (ASCO 2024) - P1 | "Background: OH2 is an attenuated oncolytic Herpes Simplex-2 virus expressing GM-CSF... In sum, our VAK therapy offers a cost-effective, extremely safe, and patient-friendly autologous treatment that dramatically increases overall survival in patients with essentially no options. Larger scale studies are in the works. Clinical trial information: NCT05565014."

IO biomarker • Oncolytic virus • Herpes Simplex • Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • Thoracic Cancer • CD8 • CSF2