omburtamab I-124 (124I-8H9) / Y-mAbs Therap - LARVOL DELTA

Determination of the Intralesional Distribution of Theranostic 124I-Omburtamab Convection-Enhanced Delivery in Treatment of Diffuse Intrinsic Pontine Glioma. (PubMed, J Nucl Med) - " CED of 124I-Omburtamab is a novel approach for delivering radiolabeled therapies into brain-stem tumors. Imaging enabled quantification of radiation dose coverage within the MRI-defined tumor target, highlighting the importance of precise alignment between therapeutic agent distribution and tumor volume."

Journal • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Glioma • Oncology • Solid Tumor

Phase 1 dose-escalation trial using convection-enhanced delivery (CED) of radio-immunotheranostic 124I-Omburtamab for diffuse intrinsic pontine glioma (DIPG). (PubMed, Neuro Oncol) - "Administration of 124I-Omburtamab via CED is a safe treatment option for DIPG, with a maximum tolerated activity level identified. This study represents the first in-human theranostic use of a 124I radiopharmaceutical, simultaneously, as an imaging and therapeutic agent."

Journal • P1 data • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Glioma • Oncology • Pediatrics • Solid Tumor

Theranostic Intratumoral Convection-Enhanced Delivery of 124I-Omburtamab in Patients with Diffuse Intrinsic Pontine Glioma: Pharmacokinetics and Lesion Dosimetry. (PubMed, J Nucl Med) - "It allows for delivery of high radiation doses to the DIPG lesions, with high lesion activities and low systemic activities and high tumor-to-normal-tissue ratios and achieving a wide safety margin. Imaging of the actual therapeutic administration of 124I-omburtamab allows for direct estimation of the therapeutic lesion and normal-tissue-absorbed doses."

Journal • PK/PD data • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Glioma • Oncology • Solid Tumor

[VIRTUAL] Repeat Convection-Enhanced Delivery for Diffuse Intrinsic Pontine Glioma (SNO 2020) - P1 | " Patients were enrolled in a phase I single center clinical trial using 124I-8H9 monoclonal antibody (124I-Omburtamab, Y-mAbs Therapeutics) administered by CED (NCT01502917)... This series demonstrates the ability to safely perform sequential CED infusions into the pediatric brainstem. Past treatments did not negatively influence the procedural work flow, technical application of the targeting interface, or distribution capacity. This limited experience provides a foundation for using repeat CED for oncologic purposes."

Cardiovascular • Cerebral Hemorrhage • Diffuse Intrinsic Pontine Glioma • Glioma • Hematological Disorders • Oncology • Pediatrics • Solid Tumor • MRI

Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: Y-mAbs Therapeutics | Terminated ➔ Completed

Trial completion • Brain Cancer • Glioma • Oncology • Solid Tumor

Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy (clinicaltrials.gov) - P1 | N=50 | Terminated | Sponsor: Y-mAbs Therapeutics | Recruiting ➔ Terminated; Stopping rule was met per protocol as a result of the last two subjects experiencing dose limiting toxicities.

Trial termination • Brain Cancer • Glioma • Oncology • Solid Tumor

[VIRTUAL] Phase 1 dose-escalation trial using convection-enhanced delivery of radiolabeled monoclonal antibody for diffuse intrinsic pontine glioma following external radiation therapy. (ASCO 2021) - P1 | "124I-omburtamab via CED into the brain stem of children with DIPG and previously irradiated provides a possibility for improved treatment of DIPG . A dose of 8mCi and an infusion volume of 8,000 µl is considered safe and may provide a distribution volume large enough to cover tumor volumes up to 20 cm3 . The median overall survival of all patients included in the trial appears to be increased with 3-4 months compared to historical control data from consortia trials ."

P1 data • Ataxia • Brain Cancer • CNS Disorders • Diffuse Intrinsic Pontine Glioma • Gastrointestinal Disorder • Glioma • Movement Disorders • Oncology • Solid Tumor • CD276

Y-mAbs Announces Update on Omburtamab for DIPG (GlobeNewswire) - P1, N=64; NCT01502917; Sponsor: Y-mAbs Therapeutics; "Y-mAbs Therapeutics...will present interim phase 1 dose-escalation data for omburtamab for diffuse intrinsic pontine glioma ('DIPG') at the American Society of Clinical Oncology ('ASCO') Virtual Annual Meeting on June 4, 2021...The median overall survival of all 46 patients in the study increased by three to four months as compared to the historical control group. The study will continue dose escalation for both infused volume and dose."

P1 data • Glioma • Oncology

Y-mAbs Enters into Exclusive Distribution Agreement with Adium Pharma S.A. for DANYELZA (naxitamab-gqgk) and Omburtamab in Latin America (GlobeNewswire) - "Y-mAbs Therapeutics...announced today that it has entered into an exclusive distribution agreement with Adium Pharma S.A. ('Adium') to be the exclusive distributor in Latin America of the Company’s antibodies, DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma...The Company aims to resubmit its Biologics License Application ('BLA') to the FDA for omburtamab by the end of the second quarter or in the third quarter 2021."

BLA • Licensing / partnership • Neuroblastoma • Oncology • Solid Tumor

Y-mAbs Announces Data to be Presented at 2021 ASCO Annual Meeting (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...is pleased to announce the acceptance of two poster presentations for DANYELZA and an oral presentation for omburtamab at the American Society of Clinical Oncology ('ASCO') Virtual Annual Meeting, taking place virtually from June 4, 2021 to June 8, 2021."

Clinical data • Glioma • Neuroblastoma • Oncology

Convection-Enhanced Delivery of 124I-Omburtamab for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: Y-mAbs Therapeutics; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Brain Cancer • Glioma • Oncology • Solid Tumor

Y-mAbs Signs License Agreement with SciClone for DANYELZA (naxitamab-gqgk) and Omburtamab in China (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...announced today that it has entered into a license agreement with SciClone Pharmaceuticals International Ltd...to be the exclusive co-development and commercialization partner of the Company’s antibodies, DANYELZA® (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab, if approved, for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in China."

Licensing / partnership • Neuroblastoma • Oncology

Repeat convection-enhanced delivery for diffuse intrinsic pontine glioma. (PubMed, J Neurosurg Pediatr) - P1 | "This series demonstrates the ability to safely perform sequential CED infusions into the pediatric brainstem. Past treatments did not negatively influence the procedural workflow, technical application of the targeting interface, or distribution capacity. This limited experience provides a foundation for using repeat CED for oncological purposes."

Journal • Cardiovascular • Cerebral Hemorrhage • Diffuse Intrinsic Pontine Glioma • Glioma • Hematological Disorders • Oncology • Pediatrics • Solid Tumor

Convection-Enhanced Delivery of 124I-8H9 for Patients With Non-Progressive Diffuse Pontine Gliomas Previously Treated With External Beam Radiation Therapy (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: Y-mAbs Therapeutics; Trial completion date: Dec 2018 ➔ Dec 2020; Trial primary completion date: Dec 2018 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date