tasadenoturev (DNX-2401) / DNAtrix - LARVOL DELTA

Emerging therapies for glioblastoma. (PubMed, J Neurooncol) - "Glioblastoma (GBM) remains associated with poor outcomes, with a median survival of 15-18 months despite maximal safe resection, radiotherapy, and temozolomide. CAR T-cell therapies are advancing toward bispecific and armored constructs with locoregional delivery, while oncolytic viruses such as DNX-2401 and PVSRIPO demonstrate potential for durable responses in select patients. Looking ahead, progress is likely to arise from biomarker-informed, multimodal regimens that integrate targeted agents, next-generation immunotherapies, and precision-guided strategies, while embedding translational endpoints into trial design to address the complex biology and therapeutic resistance of GBM."

IO biomarker • Journal • Review • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • BRAF • NTRK

Phase I trial of single intratumoral injection of DNX-2440 oncolytic adenovirus in recurrent glioblastoma patients (SNO 2025) - "DNX-2401, an oncolytic adenovirus engineered for tumor-selective replication and enhanced infectivity, has shown efficacy in adults with recurrent glioblastoma (GBM). Intratumoral DNX-2440 administration is feasible and safe, with early signs of clinical activity. These findings support the continued exploration of oncolytic virotherapy as a platform for immunomodulation and combination strategies in GBM."

Clinical • Oncolytic virus • P1 data • Brain Cancer • Glioblastoma • Immunology • Oncology • Solid Tumor

Oncolytic virotherapy: molecular mechanisms, delivery strategies, and translational insights. (PubMed, Crit Rev Oncol Hematol) - "We highlight trials where OVs prime checkpoint response (e.g., DNX-2401→pembrolizumab in recurrent glioblastoma) and where vector design (e.g., TK-deleted vaccinia, CG0070) or payloads (e.g., IFNβ, NIS) drive measurable benefit. We conclude with actionable priorities, patient selection by IFN-pathway competence, receptor-tropism panels, and rational OV-ICI sequencing, to accelerate durable responses."

Journal • Review • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IFNB1

Phase I trial of single intratumoral injection of DNX-2440 oncolytic adenovirus in recurrent glioblastoma patients (WFNOS 2025) - "DNX-2401, an oncolytic adenovirus engineered for tumor-selective replication and enhanced infectivity, has shown efficacy in adults with recurrent glioblastoma (GBM). Intratumoral DNX-2440 administration is feasible and safe, with early signs of clinical activity. These findings support the continued exploration of oncolytic virotherapy as a platform for immunomodulation and combination strategies in GBM."

Clinical • Oncolytic virus • P1 data • Brain Cancer • Glioblastoma • Immunology • Solid Tumor

The Emerging Role of Oncolytic Virotherapy in Glioblastoma Management. (PubMed, Cancers (Basel)) - "Despite maximal resection, radiotherapy, and temozolomide, median survival is still 12-15 months because of tumor heterogeneity, diffuse infiltration, and therapeutic resistance...Several viral backbones have advanced to clinical testing, including adenovirus (DNX-2401), herpes simplex virus (G47Δ, G207), poliovirus (PVS-RIPO), measles virus (MV-CEA), reovirus (pelareorep), vaccinia virus (Pexa-Vec), and vesicular stomatitis virus (VSV-GP)...Advances in delivery, such as convection-enhanced infusion and blood-brain barrier modulation, are also under investigation. Despite obstacles, oncolytic virotherapy holds significant potential within multimodal GBM strategies."

Journal • Review • Brain Cancer • Glioblastoma • Glioma • Herpes Simplex • High Grade Glioma • Infectious Disease • Measles • Oncology • Solid Tumor

The effect of oncolytic virotherapy on pediatric brain tumor- a systematic review. (PubMed, Childs Nerv Syst) - "OVT appears safe and feasible in pediatric brain tumors, with signals of clinical benefit in selected patients. Larger, controlled trials are needed to clarify its survival impact and define optimal therapeutic strategies."

Journal • Review • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Diffuse Intrinsic Pontine Glioma • Ependymoma • Glioblastoma • Glioma • High Grade Glioma • Oncology • Pain • Pediatrics • Solid Tumor

Assessing Nectin and Nestin Expression in Diffuse Midline Gliomas: A Step Toward HSV-Based Oncolytic Viral Immunotherapy (USCAP 2025) - P1 | "Additionally, the oncolytic adenovirus DNX-2401 has shown promising results in treating diffuse intrinsic pontine gliomas (DIPG), a subset of DMGs, in pediatric patients (NCT03178032). The co-expression of Nectin and Nestin in DMGs is significant, as it suggests that these tumors may be suitable candidates for CAN-3110 oncolytic immunotherapy. Further studies are needed to explore the therapeutic potential and clinical application of this approach in DMGs."

IO biomarker • Oncolytic virus • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Diffuse Midline Glioma • Glioblastoma • Glioma • Malignant Glioma • Oncology • Pediatrics • Solid Tumor • NES

Efficacy of Oncolytic Viral Therapy in Pediatric Brain Tumors: A Systematic Review of Clinical Trials (AAN 2025) - "The virus agents used in studied were HSV G-207, DNX-2401, and ADV-tk...The majority of patients underwent additional treatments, including radiotherapy, surgery and chemotherapy, with temozolomide and lomustine being the most frequently used chemotherapeutic agents...Early-phase trials suggest that oncolytic virotherapy is generally well-tolerated and shows potential efficacy especially if it used as an adjuvant therapy along with chemotherapy, radiotherapy or surgery. However, larger and more advanced clinical trials are required to determine survival rates, adverse effects and make definitive comparisons with conventional therapeutic approach."

Clinical • IO biomarker • Oncolytic virus • Review • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Ependymoma • Glioblastoma • Glioma • Hepatocellular Cancer • Hepatology • Malignant Glioma • Melanoma • Oncology • Pain • Pancreatic Cancer • Pediatrics • Solid Tumor

A viral attack on brain tumors: the potential of oncolytic virus therapy. (PubMed, J Neurovirol) - "Furthermore, the discovery and creation of new OVs that can seamlessly integrate gene therapy strategies, such as cytotoxic, anti-angiogenic, and immunostimulatory, are promising advancements. This review presents an overview of the latest advancements in OVs transduction for brain cancer, focusing on the safety and effectiveness of G207, G47Δ, M032, rQNestin34.5v.2, C134, DNX-2401, Ad-TD-nsIL12, NSC-CRAd-S-p7, TG6002, and PVSRIPO. These are evaluated in both preclinical and clinical models of various brain tumors."

Journal • Oncolytic virus • Review • Brain Cancer • Gene Therapies • Oncology • Solid Tumor

Oncolytic DNX-2401 virotherapy plus pembrolizumab in recurrent glioblastoma: a phase 1/2 trial | Nature Medicine

MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Sep 2023 ➔ Sep 2027 | Trial primary completion date: Sep 2023 ➔ Sep 2027

Oncolytic virus • Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor • IDH1

Systemic immune correlates associated with long-term survival after Therapeutic Adenovirus (DNX2401) plus Interferon gamma for Recurrent Glioblastoma Effect Trial (TARGET): a randomized phase 1 trial. (SNO 2023) - P1b | "Overall, these data suggest that an early and robust systemic adaptive immune response could be used as a biomarker for long term survival following DNX-2401 treatment of recurrent glioblastoma independent of other salvage treatments administered following disease progression during the trial. (Clinical Trial.gov registration: NCT02197169)."

Clinical • IO biomarker • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD8 • IFNG

Oncolytic DNX-2401 virotherapy plus pembrolizumab in recurrent glioblastoma: a phase 1/2 trial (SNO 2023) - P2 | "Exploratory mutational, gene-expression and immunophenotypic analyses revealed that the balance between immune cell infiltration and expression of checkpoint inhibitors may potentially inform on response to treatment and mechanisms of resistance. Overall, the combination of intratumoral DNX-2401 followed by pembrolizumab was safe with notable survival benefit in select patients (ClinicalTrials.gov registration: NCT02798406)."

IO biomarker • Oncolytic virus • P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

MRI-aided SmartFlow convection delivery of DNX-2401: a pilot, prospective case series. (PubMed, World Neurosurg) - P2 | "Our pilot case series supports compatibility of the SmartFlow system with oncolytic adenovirus delivery and provides the basis for future validation studies."

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

THANK PHASE I TRIAL OF DNX-2440 ONCOLYTIC ADENOVIRUS IN PATIENTS WITH FIRST OR SECOND RECURRENCE OF GLIOBLASTOMA: PRELIMINARY RESULTS (EANO 2023) - "The oncolytic adenovirus DNX-2401, genetically engineered for selective replication and enhanced infectivity in tumor cells, has shown efficacy in adult patients with recurrent glioblastoma (GBM). CONCLUSIONOur current data suggest that intratumoral injection of DNX-2440 is feasible and safe, and seems to provide a clinical benefit in some patients with recurrent GBM. Furthermore, this trial illustrates the potential of oncolytic virus platforms to reshape the brain-tumor microenvironment and its interesting role in combination strategies with other immune-oncology agents for treating this disease."

Clinical • IO biomarker • Oncolytic virus • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

B Phase I Trial Of Dnx-2401 Oncolytic Adenovirus Combined With A Short Course Of Dose-Dense Temozolomide For Recurrent Glioblastoma (EANO 2023) - "Our data suggest that treatment with DNX-2401 followed by a short-course of dose-dense TMZ is feasible, can be safely administered with expected adverse events related to chemotherapy, and appears to render a clinical benefit in a subset of patients with recurrent GBM. Further assessment of this therapeutic approach is warranted."

Oncolytic virus • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • IDH1 • IDH2 • MGMT

Oncolytic virotherapies for pediatric tumors. (PubMed, Expert Opin Biol Ther) - "We reviewed seven virus types that have been investigated in past or ongoing pediatric tumor clinical trials: adenovirus (AdV-tk, Celyvir, DNX-2401, VCN-01, Ad-TD-nsIL-12), herpes simplex virus (G207, HSV-1716), vaccinia (JX-594), reovirus (pelareorep), poliovirus (PVSRIPO), measles virus (MV-NIS), and Senecavirus A (SVV-001). However, the antitumor effects of OVT remain variable depending on tumor type and viral agent used. Although the widespread adoption of OVT faces many challenges, we are optimistic that OVT will play an important role alongside standard chemotherapy and radiotherapy for the treatment of malignant pediatric solid tumors in the future."

Journal • Oncolytic virus • Review • Herpes Simplex • Infectious Disease • Measles • Oncology • Pediatrics • Solid Tumor

Oncolytic virotherapy evolved into the fourth generation as tumor immunotherapy. (PubMed, J Transl Med) - "OVs, which are advancing into clinical trials, are being envisioned as the frontier clinical anti-tumor agents coming soon."

Journal • Oncolytic virus • Review • Oncology

DNX-2401 plus Pembrolizumab Is Safe in Recurrent Glioblastoma. (PubMed, Cancer Discov) - "Pembrolizumab plus the oncolytic virus DNX-2401 is safe and efficacious in a subset of patients with glioblastoma."

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Oncolytic DNX-2401 virotherapy plus pembrolizumab in recurrent glioblastoma: a phase 1/2 trial. (PubMed, Nat Med) - P2 | "Exploratory mutational, gene-expression and immunophenotypic analyses revealed that the balance between immune cell infiltration and expression of checkpoint inhibitors may potentially inform on response to treatment and mechanisms of resistance. Overall, the combination of intratumoral DNX-2401 followed by pembrolizumab was safe with notable survival benefit in select patients (ClinicalTrials.gov registration: NCT02798406)."

IO biomarker • Journal • Oncolytic virus • P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

"Oncolytic DNX-2401 virotherapy plus pembrolizumab in recurrent glioblastoma- ORR 10.4%, 1 year OS 52.7% https://t.co/tM3PAc7I27" (@drkpavithran)

Oncolytic virus • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Oncolytic DNX-2401 Virus for Pediatric Diffuse Intrinsic Pontine Glioma. (PubMed, N Engl J Med) - P1 | "Intratumoral infusion of oncolytic virus DNX-2401 followed by radiotherapy in pediatric patients with DIPG resulted in changes in T-cell activity and a reduction in or stabilization of tumor size in some patients but was associated with adverse events. (Funded by the European Research Council under the European Union's Horizon 2020 Research and Innovation Program and others; EudraCT number, 2016-001577-33; ClinicalTrials.gov number, NCT03178032.)."

Journal • Oncolytic virus • Brain Cancer • Diffuse Intrinsic Pontine Glioma • Fatigue • Glioma • Oncology • Pain • Pediatrics • Solid Tumor

Oncolytic Adenovirus, DNX-2401, for Naive Diffuse Intrinsic Pontine Gliomas (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Clinica Universidad de Navarra, Universidad de Navarra | Unknown status ➔ Completed

Oncolytic virus • Trial completion • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Glioma • Oncology • Pediatrics • Solid Tumor

Safety and Efficacy of DNX-2401 Oncolytic Virus for Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (SNO 2022) - No abstract available

Clinical • Oncolytic virus • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Glioma • Oncology • Solid Tumor

Phase I clinical trial with oncolytic virus DNX-2401 for naive DIPGs (SNO 2019) - P1; "In addition, we are assessing the existence of pre and post treatment neutralizing antibodies and its relationship with survival. Finally, we have performed functional studies using 2 cell lines isolated from patients included in this trial and confronting them with T-cells isolated from peripheral blood of the same patients before and after the treatment with the virus Information acquired within this clinical study would aid to understand the response of DIPGs to viral therapies and therefore to better tailor this strategy to improve the survival of pediatric brain tumors."

Clinical • Late-breaking abstract • Oncolytic Virus • P1 data