cintredekin besudotox (IL13PE38) / Precision NeuroMed - LARVOL DELTA

Delivery quality, not drug biology, determines survival in the Phase III PRECISE Trial of IL13-PE38QQR: A physics-informed per-patient CED analysis (SNO 2026) - No abstract available

Clinical • P3 data • IL13

Recurrence patterns and site-level survival in the previous phase III study of IL13-PE38QQR: Implications for drug distribution variability. (ASCO 2026) - P3 | "Clinical outcomes following IL13-PE38QQR therapy were strongly associated with delivery efficiency and treatment-team experience. Radiolabeled distribution studies, experience-dependent survival effects, and recurrence patterns in long-term survivors indicate that outcome variability was driven primarily by technical limitations in drug delivery rather than tumor biology. This study represented the first large-scale evaluation of CED in the absence of purpose-built delivery technology, relying on complex, nonstandardized surgical workflows."

P3 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • IL13

Precision NeuroMed Granted FDA Orphan Drug Designation by U.S. FDA for Treatment of Glioblastoma Multiforme (GBM) (PRNewswire)

Orphan drug • Glioblastoma

Locoregional infusion of IL13Rα2-specific immunotoxins in children and adults with high-grade glioma. (PubMed, Ther Deliv) - No abstract available

Journal • Brain Cancer • Diffuse Midline Glioma • Glioblastoma • Glioma • Oncology • Solid Tumor • IL13RA2

Phase I trial of convection-enhanced delivery of IL13-Pseudomonas toxin in children with diffuse intrinsic pontine glioma. (PubMed, J Neurosurg Pediatr) - "This was a Phase I single-institution, open-label, dose-escalation, safety and tolerability study of IL13-PE38QQR infused via single-catheter CED into 5 pediatric DIPG patients...The patients' performance status did not improve. Drug delivery using multiple catheters may produce improved outcomes.Clinical trial registration no.: NCT00088061 (clinicaltrials.gov)."

Clinical • Journal • P1 data

Convection-Enhanced Delivery in Malignant Gliomas: A Review of Toxicity and Efficacy. (PubMed, J Oncol) - "...The phase III trial PRECISE compares CED of IL13-PE38QQR, an interleukin-13 conjugated to Pseudomonas aeruginosa exotoxin A, to Gliadel® Wafer, a polymer loaded with carmustine...In phase II studies, CED of recombinant poliovirus (PVSRIPO) had an overall survival of 21% vs. 14% for the control group at 24 months, and 21% vs. 4% at 36 months...On the other hand, the TGF-β2 inhibitor Trabedersen, HSV-1-tk ganciclovir, and radioisotope I-chTNT-1/B mAb had a limited response rate. With this treatment, patients who received CED of the chemotherapeutic agent paclitaxel and immunomodulator, oligodeoxynucleotides containing CpG motifs (CpG-ODN), experienced intolerable toxicity. Toward the end of this article, an ideal CED treatment procedure is proposed and the methods for quality assurance of the CED procedure are discussed."

Clinical • Journal • Review