BS001 / Wuhan Binhui Biotech - LARVOL DELTA

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

A phase II study of an oncolytic herpes simplex virus 2 and an anti-PD-1 antibody in patients with advanced sarcoma. (ASCO 2024) - "OH2 and HX008 demonstrated goodsafety and encouraging anti-tumor activity in a phase II sarcoma cohort. Further clinical investigation of this combination is warranted. 1."

Clinical • Metastases • P2 data • Anemia • Angiosarcoma • Fibrosarcoma • Hematological Disorders • Herpes Simplex • Neutropenia • Oncology • Sarcoma • Solid Tumor • CSF2

First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer (clinicaltrials.gov) - P2 | N=7 | Terminated | Sponsor: Binhui Biopharmaceutical Co., Ltd. | N=60 ➔ 7 | Trial completion date: Dec 2024 ➔ Apr 2024 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2024 ➔ Apr 2024; Strategy adjustment

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

VP5 protein of oncolytic herpes simplex virus type 2 induces apoptosis in A549 cells through TP53I3 protein. (PubMed, Virology) - "These revelations illuminate the underlying mechanisms of OH2's antitumor activity and underscore the pivotal role played by the VP5 protein. The outcomes of our study harbor promising implications for the formulation of effective oncolytic virotherapy strategies in cancer treatment."

Journal • Herpes Simplex • Oncology • Solid Tumor

OH2 oncolytic virus: A novel approach to glioblastoma intervention through direct targeting of tumor cells and augmentation of anti-tumor immune responses. (PubMed, Cancer Lett) - P1/2 | "Significantly, these discoveries have driven the initiation of a phase I/II clinical trial (ClinicalTrials.gov: NCT05235074). This trial is designed to explore the potential of OH2 as a therapeutic option for patients with recurrent central nervous system tumors following surgical intervention."

IO biomarker • Journal • Oncolytic virus • Tumor cell • Brain Cancer • CNS Tumor • Glioblastoma • Herpes Simplex • Oncology • Solid Tumor • CD4 • CD8 • CDKN2A • CDKN2B • IDO1 • IRS4

OH2 Oncolytic Viral Therapy in Solid Tumors (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Trial completion date: Apr 2023 ➔ Aug 2024 | Trial primary completion date: Apr 2023 ➔ Aug 2024

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

First-line Maintenance of OH2 Injection for Advanced Colorectal Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Binhui Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor