Daiichi Sankyo Files NDA for a New Oncolytic Virus in Japan
On January 5th, Daiichi Sankyo announced the submission of 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.
First Oncolytic Virus for Malignant Glioma
Oncolytic viruses are genetically edited viruses that are intended to break down cancer cells without affecting normal tissues. Oftentimes, the Oncolytic virus is incorporated with chemotherapy, radiation therapy, or immunotherapy to elevate the efficacy of treatment.
Oncorine, which was authorized by the Chinese SFDA in 2005 for nasopharyngeal carcinoma in combination with chemotherapy was the first oncolytic virus approved in the world. In 2015, T-VEC, a modified herpes simplex virus (HSV) for treating melanoma became the first oncolytic virus approved by the USFDA.
At present, no oncolytic viruses are currently approved for malignant glioma, an aggressive primary brain cancer. If approved, teserpaturev could potentially be the first oncolytic virus therapy for patients with malignant gliomas in Japan and in the world.
Co-Developed by Daiichi Sankyo and the University of Tokyo
Teserpaturev is an oncolytic herpes simplex virus type 1 (HSV-1) co-developed by Daiichi Sankyo and Dr. Tomoki Todo, Professor at the Institute of Medical Science, University of Tokyo. It has triple mutations in the viral genome that replicate selectively in cancer cells and enhance the induction of antitumor immune response while maintaining high safety.
Prior to this NDA submission, teserpaturev has received Orphan Drug Designation in 2017 and SAKIGAKE Designation in 2016 for treating malignant glioma.
Phase 2 Clinical Trial
The NDA is based on the single-arm, Phase 2 clinical trial published on November 11th. Every patient in the trial was injected stereotactically with teserpaturev several times in the tumor and injected in different coordinates every 4 weeks for 6 times at most. Patients also received maintenance chemotherapy (temozolomide) besides teserpaturev.
In the interim analysis, teserpaturev was found to have met the primary endpoint. The 1-year survival rate of the 13 patients in the trial was 92.3%, which was much higher than the preset control value, and only 2 patients experienced severe adverse events like grade 2 fever. What’s more, teserpaturev remained safe after 6 injections into the brain.
New Options for Malignant Glioma Treatment
Malignant glioma is an aggressive brain cancer that includes 80% of all malignant primary brain tumors. In Japan, there are 5,000 grade 1 and 2 cases in a year and 2,800 grade 3 and 4 cases annually. The effectiveness of teserpaturev could meet the unmet medical need in the market and possibly give new options to patients.