Oncorine (recombinant human adenovirus type 5) / Mergen Ltd. - LARVOL DELTA

Phase II, Open-Label, Single-Center Clinical Trial of Oncolytic Adenovirus H101 Combined with PD-1 Inhibitor in Patients with Non-Muscle Invasive Bladder Cancer Who Have Failed BCG Therapy (ESMO 2026) - No abstract available

Clinical • Oncolytic virus • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Short-term efficacy and safety of recombinant human adenovirus type 5 combined with PD-1 immune checkpoint inhibitors and SOX regimen in neoadjuvant therapy of locally advanced gastric cancer: a retrospective study. (PubMed, Front Oncol) - "To evaluate the short-term efficacy and safety of recombinant human adenovirus type 5 (H101) combined with S-1 plus oxaliplatin, PD-1 immune checkpoint inhibitors(SOXP regimen) in the neoadjuvant treatment of patients with locally advanced gastric cancer (LAGC)...The preliminary evaluation shows that H101 administered via interventional therapy is safe in the treatment of LAGC. Additionally, the treatment-related toxicities are well-tolerated, supporting the potential clinical value of this therapeutic strategy for LAGC patients."

Checkpoint inhibition • Journal • Retrospective data • Gastric Cancer • Oncology • Solid Tumor

H101 Plus TACE for r/m HNSCC (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: West China Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2028 ➔ Dec 2028 | Trial primary completion date: Feb 2027 ➔ Jun 2028

Enrollment open • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Recent advances in oncolytic virotherapy: insights from clinical trials and combination treatment strategies. (PubMed, Virol J) - "Oncolytic virotherapy is a new and rapidly evolving treatment modality, which is promising in therapy against cancer. Clinical trials have proven that OVs can be a safe and effective way to treat cancer, making them an essential part of future therapies."

Journal • Review • Brain Cancer • Glioma • Head and Neck Cancer • Melanoma • Oncology • Solid Tumor

PRXL2B facilitates the progression of hepatocellular carcinoma and the therapeutic efficacy of oncolytic adenovirus H101 through the PI3K/AKT/PD-L1 axis. (PubMed, Biosci Trends) - "These findings indicate that PRXL2B promotes malignant phenotypes in HCC and may modulate H101 efficacy through the PI3K/AKT/PD-L1 axis. Targeting PRXL2B may therefore represent a potential strategy to enhance the therapeutic efficacy of oncolytic virus therapy in HCC."

IO biomarker • Journal • Hepatocellular Cancer • Oncology • Solid Tumor • PRXL2B

VVSHIP: Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM (clinicaltrials.gov) - P2 | N=114 | Not yet recruiting | Sponsor: Jun Huang | Initiation date: Feb 2026 ➔ Jun 2026

pMMR • Trial initiation date • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Efficacy of oncolytic viruses (OVs) in malignant tumor therapy: a review on its therapeutic aspects. (PubMed, Clin Chim Acta) - "While Imlygic remains a landmark FDA-approved treatment for melanoma, newer platforms like Delytact and H101 have received regional approvals. Key findings show that OVs are more effective when they are in synergy with immune checkpoint inhibitors like Pembrolizumab, that helps in achieving objective response rates (ORR) of up to 62% in advanced melanoma...Emerging trends, such as personalized neoantigen encoding and real-time monitoring with reporter genes, may help overcome existing delivery challenges. Integrating OVs with precision medicine and multimodal therapies is shaping the strategy for achieving durable clinical responses in the changing field of oncology."

Journal • Review • Brain Cancer • Glioblastoma • Herpes Simplex • Melanoma • Oncology • Solid Tumor

Case Report: Integration of intratumoral oncolytic adenovirus with total neoadjuvant therapy in metachronous locally advanced rectal cancer. (PubMed, Front Oncol) - "At the most recent follow-up, there was no evidence of local recurrence or distant metastasis. This case highlights the potential of oncolytic virotherapy to enhance chemotherapy and radiotherapy effects in LARC patients."

Journal • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor • TP53

A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Chongqing University Cancer Hospital

New P2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Oncolytic human adenovirus 5 (H101) modulates cell cycle progression in HPV16-positive tumors. (PubMed, Biochem Biophys Res Commun) - "In vivo experiments further confirmed the significant antitumor effects and the favorable safety profile of H101. These findings suggest that the antitumor effects of H101 are associated with the downregulation of HPV16 E6/E7 and the activation of the p53-p21 pathway, involving both p53-dependent and p53-independent mechanisms."

Journal • Cervical Cancer • Gynecology • Oncology • Solid Tumor • Women's Health • CDK1

Recombinant human adenovirus type 5 synergizes with anti-PD-L1 antibody to promote anti-hepatocellular carcinoma effects through multilevel remodeling of the immune microenvironment. (PubMed, Front Immunol) - "The combination of H101 and APA exhibited excellent anti-HCC efficacy, which may reshape the TME partially through the IFN-γ/STAT1/PD-L1 axis. These findings provide a promising strategy to overcome resistance to ICIs in HCC treatment."

IO biomarker • Journal • Hepatocellular Cancer • Oncology • Solid Tumor • CD8 • IFNG

The safety and efficacy of recombinant human adenovirus 5 injection (H101) intraperitoneal administration combined with tislelizumab and platinum, fluorouracil-based drugs in the treatment of gastric cancer with peritoneal metastasis: an open-label, single-arm, prospective clinical study protocol. (PubMed, Future Oncol) - P=N/A | "This prospective, open-label, single-arm, exploratory clinical trial aims to evaluate the safety and efficacy of intraperitoneal perfusion of recombinant human adenovirus type 5 (H101) in combination with systemic tislelizumab and platinum-fluorouracil chemotherapy (XELOX) for patients with gastric adenocarcinoma and peritoneal metastasis...As this is a study protocol, clinical results will be reported upon trial completion. If this triple-combination regimen demonstrates acceptable safety and a promising OS rate, it will provide preliminary evidence to support the further development of this multimodal approach for a high-risk population with limited therapeutic options.Clinical trial registration: chiCTR2500107607."

Clinical protocol • Journal • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Oncolytic Viruses in Cancer Immunotherapy: From Molecular Engineering to Clinical Translation. (PubMed, Cells) - "These innovations have propelled significant clinical progress, exemplified by the approvals of talimogene laherparepvec (T-VEC), G47Δ, and H101, and have driven a surge of combination trials integrating OVs with immune checkpoint blockade, adoptive cell therapies, radiotherapy, and targeted therapies to overcome multilayered tumor immune resistance...By integrating advanced viral engineering with rational combination strategies and innovative delivery technologies, OVs hold substantial potential to overcome current barriers in cancer immunotherapy and advance precision oncology. Continued translational research will be essential to fully harness their therapeutic impact and broaden their clinical applicability."

Journal • Review • Immune Modulation • Immunology • Infectious Disease • Oncology

Strategically engineering an oncolytic herpes simplex virus to improve systemic delivery. (PubMed, Mol Ther Oncol) - "Despite the recent regulatory approvals of oncolytic viruses such as T-VEC (JS1/34.5-/47-/GM-CSF), Oncorine (H101), and Teserpaturev (G47Δ), the clinical impact of OV remains limited by its reliance on intratumoral administration. Preclinical studies demonstrate that FusOn-SD efficiently reaches tumor sites following systemic administration, exhibiting enhanced immune evasion and oncolytic potency. These findings position FusOn-SD as a promising candidate for advancing OV beyond localized injections, with the potential to transform virotherapy into a viable treatment for metastatic cancer."

Journal • Herpes Simplex • Oncology • CSF2

H101 Plus TACE for r/m HNSCC (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: West China Hospital

New P2 trial • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

VVSHIP: Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM (clinicaltrials.gov) - P2 | N=114 | Not yet recruiting | Sponsor: Jun Huang

New P2 trial • pMMR • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

Intra-tumoral recombinant human adenovirus type 5 (H101) in persistent/recurrent/metastatic cervical cancer: Efficacy, safety, and mechanisms via spatial transcriptomics (ESMO-IO 2025) - "In responder stromal regions, proportions of epithelial cells, cancer-associated fibroblasts, and endothelial cells decreased, whereas myeloid cells, B cells, and T cells increased post-H101 injection.Conclusions Intra-tumoral H101-based therapy was effective and safe in P/R/M cervical cancer. Xenium profiling indicated that H101 reshaped and activated the TIME, and the therapeutic response may be associated with increased B cells and myeloid cells in the TIME."

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Case report: Local and systemic combination therapy: endoscopic injection of an oncolytic virus with PD-1 inhibitor for an elderly patient with advanced gastrointestinal cancer. (PubMed, Front Immunol) - "Subsequently, the patient was treated with an innovative regimen consisting of endoscopic intratumoral injections of Oncolytic adenovirus H101 in combination with the PD-1 inhibitor tislelizumab...The patient achieved nearly 4 months of progression-free survival and a substantial improvement in quality of life. This case highlights the potential of combining oncolytic virotherapy with PD-1 inhibition as a promising and novel personalized strategy for treating elderly patients with advanced gastrointestinal cancers who are unsuitable candidates for conventional therapies."

IO biomarker • Journal • Colorectal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CA 19-9 • CD4 • CD8

Overcoming immune resistance in advanced esophageal squamous cell carcinoma with recombinant human adenovirus type 5 by impacting the immune microenvironment: A case report (SITC 2025) - "The OVs could transiently suppress the tumor microenvironment during tumor cell lysis, potentially resulting in the temporary functional impairment of T cells and NK cells, consequently leading to a reduction in IFN-γ production.Conclusions Taken together, the intralymphatic injection of H101 combined with chemotherapy and immunotherapy may represent a promising clinical strategy for advanced ESCC patients with recurrent lymph node metastasis. Nevertheless, the efficacy and safety of H101 combination therapy in advanced ESCC needs to be validated through large-scale clinical trials in the future.Ethics Approval The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Review Board of the 900th Hospital of Joint Logistic Support Force (protocol code 2023-067).Consent A signed consent form was obtained from the patient, permitting the patient's data to be presented as a case report."

Case report • Clinical • IO biomarker • Metastases • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Squamous Cell Carcinoma • CD20 • CD4 • CD8 • IFNG • IL1B

Spatial transcriptomics unravels immune microenvironment reprogramming following H101 and anti-PD-1 combination therapy in PD-1 inhibitor-resistant melanoma (SITC 2025) - "Spatial transcriptomic dynamic monitoring revealed significant immune reprogramming in the TME following H101 treatment: CD3+/CD4+/CD8+ T cell infiltration increased 2.3-fold compared to baseline (p<0.001), with a notable increase in regulatory T cells (Tregs) that exhibited distinct transcriptional signatures from conventional suppressive Tregs, suggesting the existence of functionally reprogrammed subtypes; chemokines CXCL9 and CXCL10 expression were upregulated 4.2-fold and 3.8-fold, respectively, compared to pre-treatment levels (both p<0.001); CD68+ macrophage density increased 1.9-fold (p<0.01), however, classical M1/M2 polarization markers (iNOS, Arg1, IL-10) showed no significant changes, indicating that oncolytic virus induced a novel macrophage activation state.Conclusions This study systematically elucidates for the first time the unique immune reprogramming patterns induced by H101 combined with anti-PD-1 therapy through spatial transcriptomic..."

Combination therapy • IO biomarker • Melanoma • Oncology • Solid Tumor • CD4 • CD68 • CD8 • CXCL10 • CXCL9 • IL10

An Open-Label, Single-Arm Exploratory Clinical Study Evaluating the Efficacy and Safety of Intraperitoneal Perfusion of Recombinant Human Adenovirus Type 5 (H101) Combined with Tislelizumab, Platinum-Based, and Fluorouracil-Based Chemotherapy in the Treatment of Gastric Cancer with Peritoneal Metastasis (ChiCTR) - P=N/A | N=20 | Not yet recruiting | Sponsor: Renji Hospital ,Shanghai Jiaotong University School Of Medicine; Renji Hospital ,Shanghai Jiaotong University School Of Medicine

New trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Recombinant human adenovirus type 5 (H101) combined with Anti-PD-1 therapy in advanced melanoma resistant to PD-1 inhibitors: Mechanistic insights from spatial tumor microenvironment analysis (ESMO 2025) - P=N/A | "Conclusions In conclusion, the spatial analysis of the immune microenvironment provides evidence for the activation of a systemic anti-tumor response by H101 combined with anti-PD-1 therapy. This combination therapy have been provide a new strategy for melanoma resistant to PD-1 inhibitors, thereby enabling precise patient selection to maximize therapeutic benefits."

Biomarker • IO biomarker • Metastases • Tumor microenvironment • Melanoma • Oncology • Solid Tumor

Recombinant human adenovirus type 5 (H101) combined with PD-1 inhibitors in patients with advanced solid tumors (ESMO 2025) - "These findings provided a strong rationale for the further clinical development of this combination therapy. Legal entity responsible for the study The authors."

Clinical • Metastases • Hepatocellular Cancer • Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Sarcoma • Solid Tumor

The combination treatment of oncolytic adenovirus H101 with transcatheter arterial embolization sequential thermal ablation for hepatocellular carcinoma: a retrospective study. (PubMed, Front Oncol) - "No patient experienced a serious adverse event, or a fatal or disabling event, due to the injection of oncolytic virus. This study suggests that HI01 combined with TAE sequential thermal ablation is both safe and effective for HCC, warranting further investigation through prospective randomized controlled trials."

Journal • Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

Recombinant human adenovirus type 5 administration for the treatment of malignant ascites or pleural effusion in cancer patients: a meta-analysis. (PubMed, Front Oncol) - "The sensitivity analysis revealed high robustness of the results. H101 is effective and safe for the treatment of MA/MPE in patients with cancer and may be a promising modality for their clinical management."

Journal • Pleural effusion • Retrospective data • Review • Hematological Disorders • Leukopenia • Oncology • Respiratory Diseases