nivatrotamab (GD2xCD3) / SERB Pharmaceuticals, Memorial Sloan-Kettering Cancer Center - LARVOL DELTA

Mitigation of liver toxicity effects of bispecific T cell engagers in immune-competent liver-tumor co-culturing high-throughput platform (AACR 2024) - "Additionally, we established a solid tumor model using human cancer cell lines (HCT116-GFP) and primary cancer-associated fibroblasts, effectively mimicking the complex tumor microenvironment We treated 3D spheroid models with runimotamab (HER2xCD3 BiTE), catumaxomab (EPCAMxCD3), nivatrotamab (GD2xCD3) and control bispecific antibodies in the presence of peripheral blood mononuclear cells (PBMCs)...To mitigate potential liver toxicity, we co-treated spheroid co-cultures with adalimumab (anti-TNF), tocilizumab (anti-IL-6R), raleukin (IL-1R antagonist) (each 100ug/ml), desatanib, dexamethasone or ruxolitinib (each 100nM)...In summary, we have developed a relevant, high-throughput platform for the evaluation of novel immunotherapies closely reflecting clinical scenarios. High throughput of the assay represents a powerful screening tool for clinical candidate development."

Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=3 | Terminated | Sponsor: Y-mAbs Therapeutics | N=69 ➔ 3 | Trial completion date: Dec 2024 ➔ Apr 2022 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Apr 2022; Study terminated due to business priorities

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Study of the Safety and Efficacy of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma, Osteosarcoma and Other Solid Tumor Cancers (clinicaltrials.gov) - P1/2 | N=11 | Terminated | Sponsor: Y-mAbs Therapeutics | N=30 ➔ 11 | Trial completion date: Feb 2022 ➔ Oct 2021 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2022 ➔ Oct 2021; study terminated due to business priorities

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Melanoma • Neuroblastoma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • MYC • MYCN

Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer (clinicaltrials.gov) - P1/2; N=69; Recruiting; Sponsor: Y-mAbs Therapeutics; Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer (clinicaltrials.gov) - P1/2; N=69; Not yet recruiting; Sponsor: Y-mAbs Therapeutics

Clinical • New P1/2 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Y-mAbs Announces Pipeline Update (GlobeNewswire) - "Y-mAbs...announced that data for DANYELZA® (naxitamab-gqgk), omburtamab and nivatrotamab will be presented at the Company’s R&D event, which takes place virtually today at 12 p.m. Eastern Time....DANYELZA: Dr. Mora...will present clinical data from both antibodies....In osteosarcoma, the Company will present an update on its ongoing Phase 2 study, which started more than 4 years ago at MSK and has now been approved for recruitment at two other U.S. sites....The company will also reconfirm its plan to resubmit its omburtamab BLA for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma to the FDA in the beginning of 2021."

BLA • Enrollment status • P2 data • Neuroblastoma • Oncology • Osteosarcoma • Sarcoma

Y-mAbs’ Nivatrotamab for the Treatment of Patients with Neuroblastoma Granted Orphan Drug Designation and Rare Pediatric Disease Designation by FDA (GlobeNewswire) - "Y-mAbs Therapeutics, Inc...announced that the FDA has granted Orphan Drug Designation ('ODD') and Rare Pediatric Disease Designation ('RPDD') for its leading bispecific antibody program nivatrotamab for the treatment of neuroblastoma...'We...plan to expand the ongoing study with nivatrotamab into two separate Phase 2 arms in neuroblastoma and osteosarcoma, respectively, as well as a separate Phase 2 multicenter study in small cell lung cancer. We expect to submit an IND for the lung cancer study during the fourth quarter of 2020'"

IND • New P2 trial • Orphan drug • Lung Cancer • Neuroblastoma • Oncology • Osteosarcoma • Sarcoma • Small Cell Lung Cancer