Oncorine (recombinant human adenovirus type 5)

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.

P2, N=20, Not yet recruiting, West China Hospital

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.

P=N/A, N=20, Not yet recruiting, Renji Hospital ,Shanghai Jiaotong University School Of Medicine; Renji Hospital ,Shanghai Jiaotong University School Of Medicine

P2, N=30, Not yet recruiting, Fudan University | Trial primary completion date: Jan 2026 --> Jan 2028

P2, N=25, Not yet recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

Rapid tumor shrinkage was associated with severe local inflammation and a reduction in peripheral white blood cell counts. These findings suggest that oncolytic virotherapy may elicit an abscopal effect by activating and recruiting immune cells into the tumor microenvironment.

We also observed significant increases in the expression of CD3, CD4, CD8, CD20 and IL-1β after two relapsed H101 treatments based on multiplex immunofluorescence analysis. Intralymphatic injection of H101 combined with chemotherapy and immunotherapy may represent a promising clinical strategy for advanced ESCC patients with recurrent lymph node metastasis.

By exploring recent trials, such as T-VEC with neoadjuvant chemotherapy in triple-negative breast cancer and pembrolizumab in HNSCC, highlighting its versatility. Comparative analysis with other oncolytic viruses like HF-10, oncorine (H101), and measles virus variants positions T-VEC within the virotherapy landscape. Key challenges-systemic delivery, immune clearance, and biomarker development for patient selection-are addressed alongside strategies to enhance immune modulation through novel combinations. This review underscores T-VEC's expanding role in cancer treatment, offering clinicians' and researchers' insights to optimize its therapeutic horizons across diverse malignancies.

To investigate the anti-tumor effects of an E1B55KD-deleted oncolytic adenovirus, H101, in combination with a humanized anti-PD-1 (Programmed cell death protein 1) monoclonal antibody, Camrelizumab...These results suggested that H101 may act synergistically to enhance the therapeutic efficacy of PD-1 blockade in cancer via suppressing CD47 signaling, which may promote macrophages to phagocytose tumor cells and activate CD8+ T cells. The combination of H101 with PD-1 blockade exhibits potential as a novel strategy for the treatment of cancer.

P2, N=74, Not yet recruiting, Fudan University

P1, N=56, Completed, Fudan University | Recruiting --> Completed | Phase classification: P1b --> P1 | N=25 --> 56 | Trial completion date: Mar 2025 --> Apr 2024 | Trial primary completion date: Mar 2025 --> Apr 2024