Delytact (teserpaturev) / Daiichi Sankyo - LARVOL DELTA

Advances in the Drug Development and Quality Evaluation Principles of Oncolytic Herpes Simplex Virus. (PubMed, Viruses) - "At present, four OV drugs have been approved for the treatment of cancers worldwide, two of which are oHSV drugs that have received extensive attention, known as T-VEC and Delytact. Although much progress has been achieved, there is still much work to be done regarding the optimization of treatment protocols and the quality control of oncolytic virus drugs. The approval of various oncolytic virus therapies underlines their clinical relevance, safety, and efficacy, thereby paving the way for further research aimed at overcoming the existing limitations and enhancing patient responses."

Journal • Review • Herpes Simplex • Oncology • Solid Tumor

Breaking Barriers: Animal viruses as oncolytic and immunotherapeutic agents for human cancers. (PubMed, Virology) - "Notably, four leading contenders in this domain, Rigvir® in Latvia, T-VEC in the United States, H101 in China and Teserpaturev (DELYTACT®) in Japan, have earned approval for treating metastatic melanoma (Rigvir and T-VEC), nasopharyngeal carcinoma and malignant glioma, respectively...Furthermore, we provide a thorough examination of animal-derived oncolytic viruses, highlighting their respective strengths and limitations. Lastly, we explore the promising potential of leveraging animal viruses as potent oncolytic agents, offering new avenues for enhancing the efficacy and reach of human cancer therapeutics."

Journal • Review • Brain Cancer • CNS Tumor • Glioma • Melanoma • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

An Update on the Clinical Status, Challenges, and Future Directions of Oncolytic Virotherapy for Malignant Gliomas. (PubMed, Curr Treat Options Oncol) - "In addition to ongoing and recently completed clinical trials, one OV (Teserpaturev, Delytact®) received provisional approval for GBM treatment in Japan...Recently completed oncolytic virotherapy trials can guide the way for future treatment individualization through patient preselection, enhancing the likelihood of achieving the highest possible clinical success. These trials also offer valuable insight into the numerous challenges inherent in malignant glioma treatment, some of which OVs can help overcome."

Journal • Oncolytic virus • Review • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Efficacy of Third-Generation Oncolytic Herpes Virus G47Δ Combined with Immune Checkpoint Inhibitors in Renal Cell Carcinoma Models (ASGCT 2024) - "G47Δ (teserpaturev) is a third-generation oncolytic herpes simplex virus type 1 (HSV-1) recently approved in Japan as a new drug for malignant glioma...Analysis of intratumor immune response showed a marked decrease in the proportion of regulatory T cells (Tregs) among CD4-positive cells in the combination treatment group, resulting in a significant increase in the CD8+/Tregs ratio. These results suggest that the combination therapy exhibits high efficacy for RCC via effective remodeling of the immunosuppressive tumor microenvironment."

Checkpoint inhibition • Clinical • Oncolytic virus • Brain Cancer • CNS Tumor • Genito-urinary Cancer • Glioma • Herpes Simplex • Oncology • Renal Cell Carcinoma • Solid Tumor • CD4 • CD8

Neoadjuvant use of oncolytic herpes virus G47Δ prevents local recurrence after insufficient resection in tongue cancer models. (PubMed, Mol Ther Oncolytics) - "We investigate the usefulness of administering G47Δ (teserpaturev), a triple-mutated oncolytic herpes simplex virus type 1, prior to resection...G47Δ therapy caused increased number of tumor-infiltrating CD8 and CD4 cells, increased F4/80 cells within the residual tongues, and increased expression of immune-related genes in and around the tumor. These results imply that neoadjuvant use of G47Δ is useful for preventing local recurrence after tongue cancer surgery."

Journal • Oncolytic virus • Preclinical • Head and Neck Cancer • Herpes Simplex • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Tongue Carcinoma • CD4 • CD8

Drugs under Development (Neurosurgery) (PubMed, Brain Nerve) - ""Delytact" is a viral-gene therapy that targets malignant brain tumors, such as malignant gliomas, while "Stemirac" targets against spinal contusion via self-mesenchymal implantation. Both are permitted clinical arsenals in Japan."

Journal • Surgery • Brain Cancer • CNS Tumor • Gene Therapies • Glioma • Oncology • Solid Tumor

Regulatory Issues: PMDA - Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma. (PubMed, Oncologist) - "A Japanese phase II study (Study GD01) was conducted in patients with glioblastoma who had residual or recurrent tumors after radiotherapy with concomitant temozolomide. Hence, Delytact Injection is expected to be effective to a certain level. In line with this, Delytact Injection has been approved as an option for the treatment of malignant glioma, with one of the 3 approval conditions including conducting a use-results comparison survey and resubmission of the marketing authorization application within the granted time period of 7 years, under the conditional and time-limited approval scheme described in Article 23-26 of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices."

IO biomarker • Japanese regulatory • Journal • Oncolytic virus • Review • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Herpes Simplex • Oncology • Solid Tumor

Overcoming resistance of stroma-rich pancreatic cancer with focal adhesion kinase inhibitor combined with G47Δ and immune checkpoint inhibitors. (PubMed, Mol Ther Oncolytics) - "In transgenic autochthonous PKF mice, a rare model that develops stroma-rich PDAC with a 100% penetrance and resembles human PDAC in various aspects, the prolongation of survival compared with FAKi alone was achieved only when FAKi was combined with G47Δ and immune checkpoint inhibitors. The FAKi combination therapy may be useful to overcome the treatment resistance of stroma-rich PDAC."

Checkpoint inhibition • Journal • Stroma • Gastrointestinal Cancer • Hepatology • Herpes Simplex • Immune Modulation • Inflammation • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

ONCR-GBM, a Novel Armed Oncolytic HSV-1 Vector Engineered for Efficacy and Safety in Glioblastoma (SNO 2022) - "Oncolytic viruses are a promising and active area of research in GBM with the recent approval of an oncolytic HSV-1 vector, teserpaturev (Delytact, also known as G47Δ, Daiichi Sankyo) for recurrent GBM based on an overall survival of 92% at 1 year. Additional payloads selected for interfering with the immune suppressive stroma in GBM have been evaluated for potentiating the response of IL-12 and anti PD-1 expressing HSV-1. We will present the outcome of the in vivo screen, and the selection of the optimal combination of payloads featured in ONCR-GBM clinical candidate."

Clinical • IO biomarker • Brain Cancer • Glioblastoma • Infectious Disease • Oncology • Solid Tumor • IL12A • NECTIN1

Oncolytic virus preclinical toxicology studies. (PubMed, J Appl Toxicol) - "This article summarizes the preclinical toxicology studies of the most well studied oncolytic viruses, including Oncorine, Talimogene laherparepvec, Cavatak, ONYX-015, teserpaturev, and Rigvir, a non-pathogenic ECHO-7 virus. It is concluded that oncolytic viruses have been shown to have low toxicity and high tolerability in preclinical toxicology studies."

Journal • Oncolytic virus • Preclinical • Review • Melanoma • Oncology • Solid Tumor

Teserpaturev/G47Δ: First Approval. (PubMed, BioDrugs) - "Teserpaturev/G47Δ has been approved for the treatment of malignant glioma in Japan and is currently in clinical development for the treatment of prostate cancer (phase II), malignant pleural mesothelioma (phase I) and recurrent olfactory neuroblastoma (phase I). This article summarizes the milestones in the development of teserpaturev/G47Δ leading to this first approval for the treatment of malignant glioma."

Journal • Review • Brain Cancer • Genito-urinary Cancer • Glioma • Herpes Simplex • Lung Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Neuroblastoma • Oncology • Prostate Cancer • Solid Tumor

Implications of immune cells in oncolytic herpes simplex virotherapy for glioma. (PubMed, Brain Tumor Pathol) - "Recently, another oHSV, Delytact, was granted conditional approval in Japan against GBM, highlighting it as a promising treatment...However, as these immune cells have roles in both anti-tumor and anti-viral immunity, fine-tuning of the TME using oncolytic virotherapy will be important to maximize the therapeutic efficacy. In this review, we discuss the current knowledge of oHSV, with a focus on the role of immune cells as friend or foe in oncolytic virotherapy."

Journal • Review • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Herpes Simplex • Immune Modulation • Immunology • Inflammation • Melanoma • Oncology • Solid Tumor

"Oncolytic Virus Teserpaturev Approved in Japan for Malignant Glioma https://t.co/79d4J2fmrw via @onclive" (@Japan_Guide1)

Oncolytic virus • Brain Cancer • Glioma • Oncology • Solid Tumor

Efficacy and safety of a third-generation oncolytic herpes virus G47Δ in models of human esophageal carcinoma. (PubMed, Mol Ther Oncolytics) - "PCR analyses showed that the G47Δ DNA was confined to the esophagus after intraesophageal inoculation and was not detected in major organs after oral administration. Our results provide a rationale for the clinical use of G47Δ for treating EC."

Clinical • Journal • Oncolytic virus • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Herpes Simplex • Oncology • Squamous Cell Carcinoma

Photodynamic oncolytic virotherapy incorporating genetically engineered photosensitizer KillerRed for the treatment of central nervous system malignancies (SNO 2021) - "CONCLUSION G47delta-KillerRed enables a combination of oncolytic virus therapy and PDT to augment tumor killing. This approach is being tested in in vivo mouse models using potent focused laser irradiation."

Oncolytic virus • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Herpes Simplex • Infectious Disease • Meningioma • Oncology • Solid Tumor

"First launch for Daiichi Sankyo’s oncolytic virus Delytact in Japan https://t.co/aHtqmxSax3 via @pharmaphorum" (@Lisksama1)

Launch Japan • Oncolytic virus

Daiichi Sankyo Launches DELYTACT Oncolytic Virus G47 in Japan (Daiichi Sankyo Press Release) - "Daiichi Sankyo Company, Limited...announced that it has launched DELYTACT® (teserpaturev/G47∆)*1, an oncolytic virus developed by the company in collaboration with Professor Tomoki Todo (hereinafter, Dr. Todo) of the Institute of Medical Science, The University of Tokyo. DELYTACT® received conditional and time-limited marketing approval in Japan as a regenerative medical product for treatment of malignant glioma in June 2021..."

Launch Japan • CNS Tumor • Glioblastoma • Glioma • Oncology

Oncolytic Viro-Immunotherapy: An Emerging Option in the Treatment of Gliomas. (PubMed, Front Immunol) - "In June 2021 however, as a genetically engineered OV based on herpes simplex virus-1 (G47Δ), teserpaturev got conditional and time-limited approval for the treatment of malignant gliomas in Japan. In this review, we summarize the current state of OVT, the synergistic effect of OVT in combination with other immunotherapies as well as the hurdles to successful clinical use. We also provide some suggestions to overcome the challenges in treating of gliomas."

Journal • Oncolytic virus • Review • Brain Cancer • Glioma • Herpes Simplex • Immune Modulation • Inflammation • Oncology • Solid Tumor

"Oncolytic Virus Teserpaturev Approved in Japan for Malignant Glioma https://t.co/hvEzwHNkjj via @onclive" (@Jeanne1212)

Oncolytic virus • Brain Cancer • Glioma • Oncology • Solid Tumor

Pioneering Japan Approval For Daiichi’s Oncolytic Virus In Glioma (Scripintelligence) - "Japan grants ground-breaking approval for Daiichi oncolytic virus in brain cancer on condition of additional data."

Japanese regulatory • Glioma • Oncology

"Oncolytic Virus Teserpaturev Approved in Japan for Malignant Glioma #btsm https://t.co/jK7Yw37nZi" (@OncLive)

Oncolytic virus • Brain Cancer • Glioma • Oncology • Solid Tumor

DELYTACT Oncolytic Virus G47∆ Approved in Japan for Treatment of Patients with Malignant Glioma (Daiichi Sankyo Press Release) - "Daiichi Sankyo...announced that it has received conditional and time-limited approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for DELYTACT® (teserpaturev/G47∆), an oncolytic virus, for the treatment of patients with malignant glioma...The approval of DELYTACT in Japan is based on results of a single-arm phase 2 clinical trial evaluating DELYTACT in patients with residual or recurrent glioblastoma..."

Japanese regulatory • Glioma • Oncology

Daiichi Sankyo Submits Application for Oncolytic Virus Teserpaturev (G47∆) for Treatment of Patients with Malignant Glioma in Japan (Daiichi Sankyo Press Release) - "Daiichi Sankyo Company, Limited...announced it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for teserpaturev (G47∆), an oncolytic virus, for the treatment of patients with malignant glioma....The Japan NDA submission, which took place on December 28, 2020, is based on results of a single-arm phase 2 clinical trial conducted by Dr. Todo at the University of Tokyo in patients with residual or recurrent glioblastoma tumors, which met its primary endpoint for one-year survival rate."

Japanese regulatory • Glioma • Oncology

Oncolytic virus G47Δ (DS-1647) designated as Orphan Drug under orphan drug/medical device designation system (Daiichi Sankyo Press Release) - "Daiichi Sankyo Company, Limited...announced that the oncolytic virus G47Δ*1 (DS-1647), which the company is jointly developing with Dr. Tomoki Todo, Professor at the Institute of Medical Science, the University of Tokyo (hereafter, Professor Todo), has been designated as an orphan drug for the treatment of malignant glioma*2 under the Orphan Drug/Medical Device Designation System*3 by the Ministry of Health, Labour and Welfare."

Orphan drug • Oncology