Oncorine (recombinant human adenovirus type 5)

We also observed a significant increase of infiltrated CD4+T cells in biopsy tissues after H101 treatment. Our study not only conformed the value of oncolytic viruses to reverse ICI resistance in patients with gastric cancer, but also revealed its underlying impact on immune microenvironment.

P2, N=11, Not yet recruiting, Henan Cancer Hospital

Furthermore, we showed that the combination of H101 with the immune checkpoint inhibitor PD-L1 antibody (10 mg/kg, i.p., every three days for three times) exerted synergic suppression on B16F10 tumor growth in the mice. This study demonstrates that, in addition to oncolysis, H101 inhibits melanoma growth by promoting anti-tumor immunity and inducing pyroptosis of vascular endothelial cells.

The patient is in a general good condition now without any relapse of abdominal lymph node for over a year. On this basis, we propose that the combination therapy of oncolytic virus and capecitabine could be a promising clinical therapeutic strategy for unresectable recurrent lymph node metastasis in CRC patients.

Patients with up-regulated immune-signaling pathways in tumor cells and a higher proportion of CLEC10A+ DCs and GZMK+CD8+ T cells at baseline showed a superior response to H101 treatment. Our study demonstrates promising clinical responses and tolerability of oncolytic adenovirus in treating malignant ascites and provided insights into the relevant cellular processes following oncolytic virotherapy.

P2, N=30, Not yet recruiting, Fudan University | Initiation date: Jan 2024 --> Dec 2024

P4, N=66, Recruiting, Beijing Tsinghua Chang Gung Hospital | Not yet recruiting --> Recruiting | Trial completion date: Apr 2024 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2026

P2, N=32, Not yet recruiting, First Affiliated Hospital Bengbu Medical College

This study demonstrates the potential efficacy of combining H101 with nivolumab in treating refractory advanced HCC, with well-tolerated toxicities.

P2, N=30, Not yet recruiting, Fudan University

We conducted an unprecedented work via a WES-based approach and provided preliminary insights into H101 treatment-induced genetic aberrations in which some genes (TTN, KMT2D, ALDOA, DNAH7, ADAP1, PTPN23, and THEMIS2) could be considered potential therapeutic targets of H101-containing treatment in cervical carcinoma. Moreover, the therapy-associated characteristics such as clonal evolution and a mutational signature may warrant further evaluation of H101 in clinical settings for treating cervical carcinoma.

Before, 10 mg dexamethasone was intravenously administered...Exploratory endpoints are the changes from baseline in CD4+, CD8+, Treg, Th1 and Th2. The adverse events will be monitored.

H101 injection may enhance primary tumor regression for locally advanced cervical cancer, with an acceptable safety profile. This treatment regimen should undergo further prospective randomized controlled studies.ChiCTR-OPC-15006142.

P2, N=25, Recruiting, Fudan University | Not yet recruiting --> Recruiting

P2, N=38, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital

The present study elucidates that Onco promotes intratumor T cell infiltration and improves anti-PD-1 immunotherapy, thereby providing a potent combinatorial therapeutic strategy for CRC.

Gendicine was approved for treatment of squamous cell carcinoma of the head and neck by the Chinese Food and Drug Administration (FDA) agency in 2003 as a first-ever gene therapy product. Oncorine and ONYX-015 are oncolytic adenoviral vectors that have been shown to be effective against some types of cancer...However, the use of adenoviral vectors in gene therapy is limited by several factors such as pre-existing immunity to adenoviral vectors and high immunogenicity of the viruses. Thus, innovative strategies must be continually developed so as to overcome the obstacles of using adenoviral vectors in gene therapy.

P4, N=66, Active, not recruiting, First Affiliated Hospital Xi'an Jiaotong University | Not yet recruiting --> Active, not recruiting

P4, N=66, Not yet recruiting, First Affiliated Hospital Xi'an Jiaotong University

Oncorine (H101), an approved oncolytic adenovirus in China, is the pioneer of immunotherapy for the treatment of HNCs. Pembrolizumab and nivolumab are mAbs against PD-L1 that have been approved for recurrent and metastatic HNC patients. To date, several clinical trials using immunotherapy agents and their combination are under investigation. In this review, we summarize current the interaction of tumor cells with immune cells in the tumor microenvironment of HNCs, the main strategies that have been applied for immunotherapy of HNCs, obstacles that hinder the success of immunotherapies in patients with HNCs, as well as solutions for overcoming the challenges to enhance the response of HNCs to immunotherapies.