Daiichi Sankyo Launches Delytact (Teserpaturev/G47Δ), the World’s First Oncolytic Virus Therapy for Malignant Glioma, Priced at ¥1.43 Million per Dose

On November 1, Daiichi Sankyo announced that its oncolytic virus therapy Delytact (teserpaturev/G47Δ) was officially launched in Japan for the treatment of malignant glioma.

Delytact is a genetically engineered oncolytic herpes simplex virus type 1 (HSV-1) that received conditional, time-limited approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) in June this year. It is the fourth approved oncolytic virus product globally and the first to be approved for the treatment of malignant glioma. Researchers introduced additional deletion mutations into the genome of G207, a second-generation HSV-1, to enhance its selective replication in tumor cells and its antitumor efficacy, while maintaining a high safety profile.

This August, Delytact received pricing approval at 1.43 million yen (approximately 80,000 RMB) per dose.

However, the approval of Delytact by Japan's Ministry of Health, Labour and Welfare (MHLW) is conditional; therefore, Daiichi Sankyo must confirm the safety and efficacy of the drug in follow-up trials that yield results within the next seven years. Currently, Delytact will only be available at hospitals participating in the clinical trial program, and Daiichi Sankyo has stated that it will establish a stable drug supply system as soon as possible.

Currently, four oncolytic virus products are marketed globally: Rigvir, Oncorine (Ankerui), Imlygic, and Delytact. Rigvir is a genetically modified ECHO-7 enterovirus developed by Latima. It was approved in Latvia in 2004 for the treatment of melanoma and has since received approval in several other countries, including Poland and Armenia. In November 2019, Guizhou Shengnuo Pharmaceutical signed a co-development agreement with Latima, securing exclusive rights to Rigvir in the Greater China region. Oncorine (Ankerui) is a recombinant human adenovirus type 5 injection developed by Shanghai Sunway Biotech. It was approved in China in 2005 for the palliative treatment of patients with advanced nasopharyngeal carcinoma refractory to conventional radiotherapy or combined chemoradiotherapy, in combination with a 5-FU and cisplatin chemotherapy regimen. Imlygic, a genetically modified HSV-1 developed by Amgen, was approved in 2015 for the treatment of melanoma. As the first oncolytic virus therapy to receive FDA approval, Imlygic is priced at $65,000.

In addition to the several oncolytic virus products already on the market, numerous other oncolytic virus candidates are currently under development globally. Internationally, major pharmaceutical companies such as BMS, Johnson & Johnson, AbbVie, Johnson & Johnson, Takeda, and Merck & Co. have entered this field through acquisitions or strategic collaborations. In China, multiple companies including Shengnuo Biopharma, Tasly, and Arno Pharma have licensed various oncolytic virus products, while Sanwei Biotechnology, Tiandakang Gene, Dabo Biotech, Kanghong Biotech, ImmuneOnco Biopharma, BinHui Biotech, Sinopharm Fuxinuo Biopharma, and Lepu Biopharma are also developing their proprietary oncolytic virus therapies.

Among them, the OH2 injection monotherapy from Binhui Biotechnology has entered Phase II clinical trials, while its combination therapy with PD-1/PD-L1 inhibitors is the first in China to receive approval for a registrational clinical trial; VG161, developed by Sinopharm Fuzhou Nuojian Biotechnology, was approved for a registrational clinical trial in China in September 2020, and as it concurrently carries the genes encoding IL-12, IL-15/IL-15Rα (IL-15 and the IL-15 receptor alpha subunit), and a PD-L1 blocking peptide (PDL1B), it is the world's first oncolytic virus product engineered with four immunomodulatory factors; in August this year, ImmuneOnco's intravenous herpes oncolytic virus product, MVR-T3011 IV, received approval from China's National Medical Products Administration (NMPA) to initiate clinical trials, while its independently developed product MVR-C5252 for malignant glioma has also been authorized by the US FDA for clinical trials; in October this year, SynOV1.1 adenovirus injection from Beijing Hesheng Biotechnology was approved in China for a registrational clinical trial, with the indication being monotherapy via intratumoral injection for advanced solid tumors refractory to standard therapy.