In short
Tasadenoturev (also known as DNX-2401) is an investigational oncolytic adenovirus being studied for high-grade malignant brain tumors. One authorised Phase 2 trial in the EU Clinical Trials Information System (CTIS) is testing a single intratumoral injection in 39 children and young adults with recurrent or refractory high-grade brain tumors. The substance has no marketing authorisation and remains experimental.
Key points
- Tasadenoturev is an oncolytic adenovirus, a virus engineered to infect and destroy cancer cells.
- One Phase 2 trial is authorised in the EU for high-grade malignant brain tumors in children and young adults.
- The trial plans to enrol 39 participants and is currently authorised.
- The virus is given as a single intratumoral injection directly into the tumor.
- The main measure is overall response rate (ORR), including complete response, partial response, or stable disease for at least 12 weeks.
- Tasadenoturev has no marketing authorisation and is an investigational substance.
What is tasadenoturev?
Tasadenoturev is an oncolytic adenovirus, a type of virus that has been modified to selectively infect and kill cancer cells while largely sparing healthy tissue. It is also known by several other names, including DNX-2401, Delta-24-RGD, and Ad5-Delta 24RGD. The substance is classified as a structurally diverse substance of biological origin, and it is registered in the therapeutic area of nervous system diseases. Tasadenoturev has no marketing authorisation in the product records and remains an investigational substance. The product used in the EU trial is supplied by Clínica Universidad de Navarra.
How does tasadenoturev work?
Tasadenoturev is an oncolytic virus based on adenovirus serotype 5 that has been genetically modified with an RGD motif to enhance its ability to enter cancer cells. Once inside tumor cells, the virus replicates and causes the cells to burst, releasing new viral particles that can infect neighbouring cancer cells. This direct cell-killing effect can also trigger an immune response against the tumor, as viral replication and cell death expose tumor antigens to the immune system. In a phase I study, researchers examined the mechanism of action by injecting the virus into recurrent glioblastoma tumors and then removing the tumors surgically 14 days later.
Which conditions is it studied for?
- High-grade malignant brain tumors — the authorised EU trial focuses on children and young adults with recurrent or refractory high-grade brain tumors.
- Recurrent glioblastoma — a phase I study tested tasadenoturev in 37 adults with recurrent glioblastoma, a fast-growing brain cancer.
- Recurrent glioblastoma in combination with pembrolizumab — a phase 2 study has evaluated tasadenoturev together with the immunotherapy drug pembrolizumab in adults with recurrent glioblastoma.
How is tasadenoturev given?
Tasadenoturev is given by intratumoral injection, meaning it is injected directly into the tumor. In the authorised EU trial, a single intratumoral administration of the recommended phase II dose of 5×10¹⁰ viral particles is planned. In an earlier phase I study in adults, the virus was delivered either as a single intratumoral injection or through a permanently implanted catheter, followed by surgical removal of the tumor 14 days later.
What do the clinical trials show?
One trial with tasadenoturev is registered in the EU Clinical Trials Information System. It is a Phase 2 interventional study that plans to enrol 39 participants. The trial is currently authorised, meaning it has received regulatory approval to proceed but has not yet reported results. The study investigates a single intratumoral injection of tasadenoturev in children and young adults with recurrent or refractory high-grade brain tumors.
The main outcome measure is overall response rate (ORR), defined as the percentage of patients with a complete response, partial response, or stable disease lasting at least 12 weeks, assessed according to RAPNO criteria. RAPNO criteria are standard imaging-based criteria used to evaluate tumor response in brain tumor trials. Earlier research in adults provides background: a phase I study in 37 patients with recurrent glioblastoma reported long-term survival in a subset of participants. A separate phase 2 study is evaluating tasadenoturev in combination with pembrolizumab for recurrent glioblastoma.
What side effects are known?
The supplementary sources provided do not include a detailed list of side effects for tasadenoturev. The phase I study in adults demonstrated the safety of the approach, but specific adverse event data are not included in the available source material.