Mp13-19 a Phase Ii/Iii Trial of Cg0070, an Oncolytic Adenovirus, for BCG-Refractory Non-Muscle-Invasive Bladder Cancer (Nmibc)

Packiam, Vignesh T.; Campanile, Alexa; Barocas, Daniel A.; Chamie, Karim; Davis, Ronald L.; Kader, A. Karim; Lamm, Donald L.; Yeung, Alex; Steinberg, Gary D.

doi:10.1016/j.juro.2016.02.2500

Cited by 10 publications

(6 citation statements)

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“…In the following randomized phase II/III trial in patients with non‐muscle‐invasive bladder cancer, 15 patients received CG0070 and 7 control patients received other standard intravesical therapies (BOND, NCT01438112). Although there was no apparent difference in the initial CR (8 patients of CG0070 [53%] vs 4 of control group [57%]), CG0070 treatment demonstrated a better durable response in a subset of high‐risk patients . In a single arm phase III trial that is underway, patients with BCG‐refractory non‐muscle‐invasive bladder cancer are given CG0070 intravesically at a dose of 10 12 vp weekly for 6 weeks.…”

Section: Genetically Engineered Oncolytic Virusesmentioning

confidence: 99%

“…Although there was no apparent difference in the initial CR (8 patients of CG0070 [53%] vs 4 of control group [57%]), CG0070 treatment demonstrated a better durable response in a subset of high-risk patients. (51) In a single arm phase III trial that is underway, patients with BCG-refractory non-muscle-invasive bladder cancer are given CG0070 intravesically at a dose of 10 12 vp weekly for 6 weeks. Patients who achieved a partial or complete response at 6 months after the first intervention are maintained with the same induction cycle every 6 months (BOND2, NCT02365818).…”

Section: Genetically Engineered Oncolytic Virusesmentioning

confidence: 99%

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Oncolytic virus therapy: A new era of cancer treatment at dawn

2016

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Oncolytic virus therapy is perhaps the next major breakthrough in cancer treatment following the success in immunotherapy using immune checkpoint inhibitors. Oncolytic viruses are defined as genetically engineered or naturally occurring viruses that selectively replicate in and kill cancer cells without harming the normal tissues. T‐Vec (talimogene laherparepvec), a second‐generation oncolytic herpes simplex virus type 1 (HSV‐1) armed with GM‐CSF, was recently approved as the first oncolytic virus drug in the USA and Europe. The phase III trial proved that local intralesional injections with T‐Vec in advanced malignant melanoma patients can not only suppress the growth of injected tumors but also act systemically and prolong overall survival. Other oncolytic viruses that are closing in on drug approval in North America and Europe include vaccinia virus JX‐594 (pexastimogene devacirepvec) for hepatocellular carcinoma, GM‐CSF‐expressing adenovirus CG0070 for bladder cancer, and Reolysin (pelareorep), a wild‐type variant of reovirus, for head and neck cancer. In Japan, a phase II clinical trial of G47∆, a third‐generation oncolytic HSV‐1, is ongoing in glioblastoma patients. G47∆ was recently designated as a “Sakigake” breakthrough therapy drug in Japan. This new system by the Japanese government should provide G47∆ with priority reviews and a fast‐track drug approval by the regulatory authorities. Whereas numerous oncolytic viruses have been subjected to clinical trials, the common feature that is expected to play a major role in prolonging the survival of cancer patients is an induction of specific antitumor immunity in the course of tumor‐specific viral replication. It appears that it will not be long before oncolytic virus therapy becomes a standard therapeutic option for all cancer patients.

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Section: Genetically Engineered Oncolytic Virusesmentioning

confidence: 99%

Section: Genetically Engineered Oncolytic Virusesmentioning

confidence: 99%

Oncolytic virus therapy: A new era of cancer treatment at dawn

2016

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“…Those targeting mutant TP53, mutant RAS, and neoantigens on T cells have shown great effects in mice. [213][214][215] Oncolytic virus T-Vec Approved melanoma [ 182] Telomelysin Phase II head and neck squamous cell carcinoma, esophagogastric adenocarcinoma, gastric and gastroesophageal junction adenocarcinoma [ 183] CAVATAK Phase I/II melanoma, non-muscle invasive bladder cancer, head and neck cancer, non-small cell lung cancer [ 184] CG0070 Phase II/III non muscular invasive bladder cancer [ 185] Toca511…”

Section: Oncolytic Virus Therapy and Bispecific Antibodiesmentioning

confidence: 99%

Targeted Anti‐Tumor Immunotherapy Using Tumor Infiltrating Cells

Xie

Zhang

et al. 2021

Advanced Science

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In the tumor microenvironment, T cells, B cells, and many other cells play important and distinct roles in anti-tumor immunotherapy. Although the immune checkpoint blockade and adoptive cell transfer can elicit durable clinical responses, only a few patients benefit from these therapies. Increased understanding of tumor-infiltrating immune cells can provide novel therapies and drugs that induce a highly specific anti-tumor immune response to certain groups of patients. Herein, the recent research progress on tumor-infiltrating B cells and T cells, including CD8 + T cells, CD4 + T cells, and exhausted T cells and their role in anti-tumor immunity, is summarized. Moreover, several anti-tumor therapy approaches are discussed based on different immune cells and their prospects for future applications in cancer treatment.

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“…These vectors were further enhanced, resulting in CG0070 (Ad5-E2F-E1A-E3-GMCSF) that expresses GMCSF in the E3 region and is currently tested in several clinical trials. In a 2018 phase II study published by [106], 45 patients with BCG-naïve non-muscle invasive bladder cancer were included. The overall response rate was 47% after 6 months and treatment was well tolerated.…”

Section: Clinical Vectors With Specific Cellular Promoters That Control E1amentioning

confidence: 99%

Concepts in Oncolytic Adenovirus Therapy

Mantwill

Klein

Wang

et al. 2021

IJMS

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Oncolytic adenovirus therapy is gaining importance as a novel treatment option for the management of various cancers. Different concepts of modification within the adenovirus vector have been identified that define the mode of action against and the interaction with the tumour. Adenoviral vectors allow for genetic manipulations that restrict tumour specificity and also the expression of specific transgenes in order to support the anti-tumour effect. Additionally, replication of the virus and reinfection of neighbouring tumour cells amplify the therapeutic effect. Another important aspect in oncolytic adenovirus therapy is the virus induced cell death which is a process that activates the immune system against the tumour. This review describes which elements in adenovirus vectors have been identified for modification not only to utilize oncolytic adenovirus vectors into conditionally replicating adenoviruses (CRAds) that allow replication specifically in tumour cells but also to confer specific characteristics to these viruses. These advances in development resulted in clinical trials that are summarized based on the conceptual design.

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Mp13-19 a Phase Ii/Iii Trial of Cg0070, an Oncolytic Adenovirus, for BCG-Refractory Non-Muscle-Invasive Bladder Cancer (Nmibc)

Cited by 10 publications

References 0 publications

Oncolytic virus therapy: A new era of cancer treatment at dawn

Oncolytic virus therapy: A new era of cancer treatment at dawn

Targeted Anti‐Tumor Immunotherapy Using Tumor Infiltrating Cells

Concepts in Oncolytic Adenovirus Therapy

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