177Lu-DTPA-omburtamab / SERB Pharmaceuticals - LARVOL DELTA

A phase I/II trial of intracerebroventricular 177Lu DTPA omburtamab radioimmunotherapy for leptomeningeal metastasis from solid tumors (SITC 2021) - P1/2 | "The study has been approved by each institution’s ethics board, and patients provided informed consent before taking part. Trial Registration NCT04315246"

IO biomarker • P1/2 data • Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma (clinicaltrials.gov) - P1/2 | N=2 | Terminated | Sponsor: Y-mAbs Therapeutics | N=40 ➔ 2 | Trial completion date: Dec 2024 ➔ Aug 2022 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Aug 2022; Business priorities

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Brain Cancer • Medulloblastoma • Oncology • Pediatrics • Solid Tumor

177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (Breast, NSCLC, Malignant Melanoma) (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Y-mAbs Therapeutics | N=63 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Y-mAbs’ 177Lu-omburtamab-DTPA for the Treatment of Patients with Medulloblastoma Granted Rare Pediatric Disease Designation by FDA (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...announced that the U.S. Food and Drug Administration ('FDA') has granted Rare Pediatric Disease Designation ('RPDD') for the Company’s lutetium labelled omburtamab antibody program for the treatment of medulloblastoma."

FDA event • Brain Cancer • Medulloblastoma • Oncology • Solid Tumor

[VIRTUAL] A phase I/II dose-escalation and expansion cohort study of intracerebroventricular radioimmunotherapy using 177Lu-DTPA-omburtamab in pediatric and adolescent patients with recurrent or refractory medulloblastoma (ESMO 2021) - P1/2 | "Intracerebroventricular administration of 131I-omburtamab is currently under study in patients (pts) with neuroblastoma and CNS/leptomeningeal metastases and has received breakthrough designation by the FDA. Up to 25 pts are expected to participate in Part 1 and 24 in Part 2. Key inclusion criteria include age 3-19 years; histologically confirmed medulloblastoma; available molecular classification; recurrent/refractory to frontline therapy; Lansky or Karnofsky score of 50-100, acceptable hematological status and liver and kidney function, and a life expectancy of >3 months."

Clinical • P1/2 data • Brain Cancer • Medulloblastoma • Neuroblastoma • Oncology • Solid Tumor • CD276

177Lu-DTPA-Omburtamab Radioimmunotherapy for Leptomeningeal Metastasis From Solid Tumors (clinicaltrials.gov) - P1/2; N=63; Recruiting; Sponsor: Y-mAbs Therapeutics; Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma (clinicaltrials.gov) - P1/2; N=40; Recruiting; Sponsor: Y-mAbs Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Brain Cancer • Medulloblastoma • Oncology • Pediatrics • Solid Tumor • MRI

Y-mAbs’ 177Lu-omburtamab-DTPA for the Treatment of Patients with Medulloblastoma Receives Positive Opinion on Orphan Medicinal Product Designation by EMA (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...today announced that the Committee for Orphan Medicinal Products ('COMP') of the European Medicines Agency (“EMA”) has recommended the granting of orphan medicinal product designation ('OMPD') in the European Union ('EU') for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma. The positive opinion from the EMA's COMP has been sent to the European Commission ('EC'), which is expected to grant the orphan drug designation within 30 days."

European regulatory • Brain Cancer • CNS Tumor • Medulloblastoma • Oncology

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

177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma (clinicaltrialsregister.eu) - P1/2; N=49; Sponsor: Y-mAbs Therapeutics, Inc.

Clinical • IO Biomarker • New P1/2 trial • Brain Cancer • Medulloblastoma • Oncology • Pediatrics • Solid Tumor • CD276 • MRI

Y-mAbs Announces FDA Clearance of IND for Lutetium-177 Labeled Omburtamab Antibody for Adult Indications (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...announced today that the U.S. Food and Drug Administration ('FDA') has cleared the Company’s Investigational New Drug ('IND') application for ¹⁷⁷Lu-omburtamab-DTPA for the treatment of B7-H3 positive Central Nervous System ('CNS') and Leptomeningeal Metastasis ('LM') from tumors in adult patients....The Company anticipates that an international multicenter Phase 1/2 clinical trial will be opened for the screening of adult patients with CNS/LM from B7-H3 positive tumors during the fourth quarter of 2020."

IND • New P1/2 trial • Oncology • Solid Tumor

Y-mAbs Announces FDA Clearance of IND for its Lutetium-177 Labeled Omburtamab Antibody (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...announced today that the U.S. Food and Drug Administration ('FDA') has cleared the Company’s Investigational New Drug ('IND') application for ¹⁷⁷Lu-omburtamab-DTPA for the treatment of medulloblastoma...We anticipate that an international multicenter Phase 1/2 clinical trial will be initiated for the screening of pediatric patients with medulloblastoma during the fourth quarter of 2020....'we have submitted a separate IND for a basket trial in B7-H3 positive CNS/LM cancers in adults to leverage our experience from treating more than 25 adults with ¹³¹I-omburtamab.'"

IND • New P1/2 trial • Medulloblastoma • Oncology • Solid Tumor

177Lu-DTPA-Omburtamab Radioimmunotherapy for Recurrent or Refractory Medulloblastoma (clinicaltrials.gov) - P1/2; N=40; Not yet recruiting; Sponsor: Y-mAbs Therapeutics; Trial completion date: May 2024 ➔ Oct 2024; Trial primary completion date: May 2024 ➔ Oct 2024

Clinical • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Embryonal Tumor • Medulloblastoma • Oncology • Pediatrics • Solid Tumor