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The world first oncolytic virus product for glioma was approved. The world’s fourth oncolytic virus product went to Daiichi Sankyo.
A few days ago, Daiichi Sankyo Co., Ltd. announced that its oncolytic virus product Delytact (teserpaturev/G47∆) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of malignant glioma.
It is reported that this is the fourth approved oncolytic virus product in the world and the first approved oncolytic virus product in the world for the treatment of glioma.
Prior to this, Delytact has obtained orphan drug certification for its related indications by the Ministry of Health, Labour and Welfare of Japan.
The approval of Delytact is based on the drug’s single-arm phase 2 clinical trial data for patients with recurrent glioblastoma. Interim analysis showed that 12 of the 13 patients had a survival period of up to one year after treatment Above, the one-year survival rate was 92.3%, reaching the primary endpoint. In contrast, the one-year survival rate for standard treatment of postoperative radiotherapy and chemotherapy (temozolomide) is only 15%.
Glioblastoma is a primary brain tumor that results from the canceration of glial cells in the brain tissue, accounting for 80% of all primary brain tumors. Glioblastoma has the characteristics of high malignancy, rapid disease progression, high recurrence probability, and limited follow-up treatments.
Different from traditional surgery, radiotherapy, and chemotherapy, oncolytic virus is a virus designed to infect and destroy tumors. It can selectively infect tumor cells, replicate in large quantities inside it and eventually lyse tumor cells. .
Oncolytic viruses can not only activate immune cells, but also change the tumor microenvironment and improve the therapeutic effect. Compared with other tumor treatment methods, oncolytic virus therapy has the advantages of high replication efficiency, good killing effect and less toxic side effects.
Viruses commonly used as oncolytic viruses include: Newcastle Disease Virus (NDV), Herpes Simplex Virus-1 (HSV-1), Reovirus (Reovirus) , Oncolytic Adenovirus (Oncolytic Adenovirus), etc., these viruses have certain tumor-loving properties.
Figure 丨 Intratumoral injection of Delytact can significantly reduce M2 macrophages, while increasing M1 macrophages and natural killer (NK) cells (Source: Molecular Therapy Oncolytics)
Delytact is a third-generation oncolytic virus developed based on herpes simplex virus (HSV-1), and it is also the first third-generation oncolytic cell HSV-1 currently being evaluated in clinical trials.
The first-generation oncolytic virus refers to a wild-type virus with poor killing effect and toxic side effects. The third-generation recombinant oncolytic virus developed through genetic modification, on the basis of the improved safety of the second-generation virus, also carries a variety of exogenous genes to enhance the efficacy.
Experiments show that Delytact has more obvious characteristics of specific replication and proliferation in tumor tissues, and it has almost no effect on normal cells while lysing tumor cells. This means that the drug can enhance the anti-tumor immune response while maintaining high safety. In addition, Delytact can stimulate the body’s anti-tumor immune response while lysing tumor cells, thereby enhancing the anti-tumor activity of oncolytic viruses.
In pre-clinical studies, Delytact has shown anti-tumor effects in almost all cancer types and experimental models, including solid tumor models such as breast cancer, prostate cancer, hepatocellular carcinoma, and colorectal cancer, which may be expanded in the future. Range of indications.
At present, more than 20 kinds of viruses have been used in oncolytic virus research worldwide. In recent years, many large pharmaceutical companies such as Bristol-Myers Squibb, Johnson & Johnson, Merck & Co. have increased their layout in this field through acquisitions or cooperation. There are also many companies involved in oncolytic virus research in many countries, of which more than ten companies have entered the clinical stage of self-research or imported products.
Up to now, four oncolytic virus therapies have been launched globally, but all of them are regionally marketed. The other two products are the recombinant human type 5 adenovirus injection (E1B-55KD, Ankerui) developed by Shanghai Sanwei Biological Company and Rigvir developed by Latima.
(source:internet, reference only)