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DRUG:

Oncorine (recombinant human adenovirus type 5)

i
Other names: rAd5 H101, H 101, H101
Associations
Company:
Mergen Ltd.
Drug class:
p53 stimulant
Associations
2d
New P2 trial
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Oncorine (recombinant human adenovirus type 5)
4ms
Recombinant human adenovirus type 5 promotes anti-tumor immunity via inducing pyroptosis in tumor endothelial cells. (PubMed, Acta Pharmacol Sin)
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.
Journal
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CD8 (cluster of differentiation 8) • CASP1 (Caspase 1)
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Oncorine (recombinant human adenovirus type 5)
4ms
A Case Report of Pathologically Complete Response of a Huge Lymph Node Metastasis of Colorectal Cancer After Treatment with Intratumoral Oncolytic Virus H101 and Capecitabine. (PubMed, Immunotargets Ther)
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.
Journal • Oncolytic virus
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KRAS (KRAS proto-oncogene GTPase)
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capecitabine • Oncorine (recombinant human adenovirus type 5)
7ms
Oncolytic adenovirus in treating malignant ascites: a phase II trial and longitudinal single-cell study. (PubMed, Mol Ther)
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 data • Journal • Oncolytic virus
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CD8 (cluster of differentiation 8) • CXCR6 (C-X-C Motif Chemokine Receptor 6) • GZMK (Granzyme K)
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Oncorine (recombinant human adenovirus type 5)
8ms
PTCA199-8: Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
P2, N=30, Not yet recruiting, Fudan University | Initiation date: Jan 2024 --> Dec 2024
Trial initiation date • Oncolytic virus • Metastases
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AiRuiKa (camrelizumab) • Oncorine (recombinant human adenovirus type 5)
9ms
Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
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
Enrollment open • Trial completion date • Trial primary completion date
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5-fluorouracil • oxaliplatin • leucovorin calcium • Oncorine (recombinant human adenovirus type 5)
9ms
New P2 trial • Metastases
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Lenvima (lenvatinib) • Tevimbra (tislelizumab-jsgr) • Oncorine (recombinant human adenovirus type 5)
9ms
The combination treatment of oncolytic adenovirus H101 with nivolumab for refractory advanced hepatocellular carcinoma: an open-label, single-arm, pilot study. (PubMed, ESMO Open)
This study demonstrates the potential efficacy of combining H101 with nivolumab in treating refractory advanced HCC, with well-tolerated toxicities.
Journal • Oncolytic virus • Metastases
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AFP (Alpha-fetoprotein)
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Opdivo (nivolumab) • Oncorine (recombinant human adenovirus type 5)
10ms
New P2 trial • Oncolytic virus • Metastases
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AiRuiKa (camrelizumab) • Oncorine (recombinant human adenovirus type 5)
11ms
Recombinant Human Adenovirus Type 5 (H101) Intra-Tumor Therapy in Patients with Persistent, Recurrent, or Metastatic Cervical Cancer: Genomic Profiling Relating to Clinical Efficacy. (PubMed, Drug Des Devel Ther)
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.
Journal • Tumor mutational burden • MSi-H Biomarker • Metastases
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • KMT2D (Lysine Methyltransferase 2D) • ALDOA (Aldolase Fructose-Bisphosphate A) • THEMIS2 (Thymocyte Selection Associated Family Member 2)
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KMT2D mutation • TTN mutation • PTPN2 mutation
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Oncorine (recombinant human adenovirus type 5)
over1year
Efficacy and safety of recombinant human adenovirus type 5 injection combined with transhepatic arterial embolization sequential thermal ablation for medium-and high-risk recurrent liver cancer: a prospective, open-label, randomized controlled study (ESMO 2023)
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.
Clinical
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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Oncorine (recombinant human adenovirus type 5) • dexamethasone injection
over1year
Intratumoral injection of oncolytic virus (H101) in combination with concurrent chemoradiotherapy for locally advanced cervical cancer. (PubMed, Int J Gynecol Cancer)
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.
Journal • Combination therapy • Oncolytic virus • Metastases
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Oncorine (recombinant human adenovirus type 5)
over1year
Enrollment open • Oncolytic virus • Metastases
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Lenvima (lenvatinib) • Tevimbra (tislelizumab-jsgr) • Oncorine (recombinant human adenovirus type 5)
over1year
H101 Combined With TACE for Primary Hepatocellular Carcinoma With Portal Vein Thrombosis (clinicaltrials.gov)
P2, N=38, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
New P2 trial • Combination therapy
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oxaliplatin • Oncorine (recombinant human adenovirus type 5)
over2years
Oncolytic adenovirus H101 ameliorate the efficacy of anti-PD-1 monotherapy in colorectal cancer. (PubMed, Cancer Med)
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.
Journal • Oncolytic virus
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CD8 (cluster of differentiation 8)
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Oncorine (recombinant human adenovirus type 5)
over2years
Role of Adenoviruses in Cancer Therapy. (PubMed, Front Oncol)
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.
Review • Journal • IO biomarker
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TP53 (Tumor protein P53) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • CSF2 (Colony stimulating factor 2) • CD40LG (CD40 ligand)
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Gendicine (rAd-p53 Gene Therapy) • Oncorine (recombinant human adenovirus type 5)
almost3years
Effect and Safety of Recombinant Human Adenovirus Type 5 in Advanced HCC With Stable Disease After Sorafenib Treatment (clinicaltrials.gov)
P4, N=66, Active, not recruiting, First Affiliated Hospital Xi'an Jiaotong University | Not yet recruiting --> Active, not recruiting
Enrollment closed
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AFP (Alpha-fetoprotein)
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sorafenib • Oncorine (recombinant human adenovirus type 5)
3years
New P4 trial
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AFP (Alpha-fetoprotein)
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sorafenib • Oncorine (recombinant human adenovirus type 5)
over3years
A review on the advances and challenges of immunotherapy for head and neck cancer. (PubMed, Cancer Cell Int)
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.
Review • Journal
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PD-L1 (Programmed death ligand 1)
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Oncorine (recombinant human adenovirus type 5)