On November 1, 2021, Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) announced that the oncolytic virus product Delytact (teserpaturev/G47∆) has been approved to the Ministry of Health, Labour and Welfare (MHLW) of Japan. This is the first oncolytic virus product approved to be marketed for the treatment of malignant glioma, and it is also the fourth oncolytic virus product approved for marketing globally.

Delytact (teserpaturev/G47∆) is the third-generation oncolytic herpes simplex virus type 1 (HSV-1) jointly developed by Daiichi Sankyo and the Tomoki Todo team of the University of Tokyo. It is also the first third-generation oncolysis tested in humans. Sexual HSV-1. Delytact has a triple mutation. It adds another deletion mutation (knockout α47) on the basis of the second generation HSV-1 G207, which enhances the virus's selective replication and anti-tumor activity in tumor cells while maintaining the safety of G207. . Previously, the drug was awarded the title of Orphan Drug and SAKIGAKE designation by the Ministry of Health, Labour and Welfare (MHLW) of Japan.

Delytact was approved to be listed in Japan in June this year, and was approved for pricing in August at a price of 1.43 million yen (approximately US$12,500, RMB 80,000) per dose. The approval of Delytact is based on the results of a single-arm phase 2 clinical trial conducted by Dr. Tomoki Todo at the University of Tokyo on patients with recurrent glioblastoma. The 1-year survival rate of patients with residual or recurring plasmoblastoma.

At the time of the trial, 92% of the patients treated with Delytact were still alive, which greatly exceeded the expectations of this group of patients, who usually have a one-year survival rate of only about 15%.

According to reports, approximately 2,800 new cases of malignant glioma are detected in Japan each year, adding that Delytact’s approval is conditional, which means that Daiichi Sankyo must conduct follow-up trials and produce results within the next seven years. To verify the safety and effectiveness of the drug. Currently, Delytact can only provide commercial services in hospitals participating in the clinical trial program.

▲Daiichi Sankyo Delytact Announcement (Image source: Daiichi Sankyo's official website)

Wataru Takasaki, Executive Officer of Daiichi Sankyo’s R&D Department, once said: “Delytact is the fourth type of oncology medicine approved in Japan in the past two years. Patients with glioblastoma and other malignant gliomas that cannot be controlled with existing treatment methods provide new tumor virus treatment options."

It is worth mentioning that, in addition to the field of oncology medicine, Daiichi Sankyo has also laid out pipelines in other fields and achieved surprising results.

▲The pipeline of Daiichi Sankyo Company (picture source: Daiichi Sankyo Company official website)

Although immuno-oncology is still a niche field, there are signs that the momentum in the field of oncolytic viruses is improving. The market research company BIS pointed out that more than a dozen drug candidates are currently in the mid- to late-stage clinical trials.

Recently, large pharmaceutical companies seem to have also become interested in the field of oncolytic viruses, including Johnson & Johnson, Boehringer Ingelheim, AstraZeneca, Kissei Pharma and Merck which have also recently conducted transactions in this field.

Late-stage drug candidates include DNAtrix's tasadenoturev for recurrent glioblastoma, GeneLux's Olvi-Vec for ovarian cancer, Merck/Viralytics' Cavatek for various solid tumors, and Oncolytics Biotech's for breast cancer. pelareorep.

Source: Medical Microphone News

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