Naxitamab

Opportunity for indication expansion

Neuroblastoma and other related tumors are associated with overexpression of GD2, a disialoganglioside that has limited expression on normal cells.1 Naxitamab is a humanized monoclonal antibody (mAB) that can bind to GD2 and trigger immune-mediated cell death through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).2

We continue to advance our naxitamab platform with the belief that naxitamab has the potential to treat a broad range of cancers, including osteosarcoma, soft-tissue sarcomas, triple-negative breast cancer, and melanoma.

Naxitamab Pipeline

STUDY

Therapeautic Areas

PRECLINICAL

PHASE I

PHASE II/
PIVOTAL

SPONSOR

Status

201

Relapsed/Refractory High-Risk Neuroblastoma (Pediatric)

Preclinical

Phase I

PHASE II/ PIVOTAL

FDA Accelerated Approval and Recruiting

DFCI Pedi Slow Infusion (with irinotecan, temozolomide)

Relapsed/Refractory High-Risk Neuroblastoma

Preclinical

Phase I

PHASE II/ PIVOTAL
Recruiting
BCC-018 (with induction chemotherapy)
Newly Diagnosed High-Risk Neuroblastoma

Preclinical

Phase I

PHASE II/ PIVOTAL
Recruiting

OSU-22237
(with gemcitabine and TGFBi NK cells)

Refractory Metastatic HER2-Negative Breast Cancer

Preclinical

Phase I

PHASE II/ PIVOTAL
Recruiting
BUTTERFLY
Refractory Ewing Sarcoma

Preclinical

Phase I

PHASE II/ PIVOTAL
Recruiting
ADC Combination (with sacituzumab govitecan)
Relapsed Triple-Negative Breast Cancer

Preclinical

Phase I

PHASE II/ PIVOTAL
In development
NICE (with ifosfamide, carboplatin, etoposide)

Relapsed/Refractory High-Risk Neuroblastoma

Preclinical

Phase I

PHASE II/ PIVOTAL

Completed

17-251 (with irinotecan, temozolomide)

Relapsed/Refractory High-Risk Neuroblastoma

Preclinical

Phase I

PHASE II/ PIVOTAL

Completed

16-1643 (as consolidation of first remission)

Newly Diagnosed High-Risk Neuroblastoma

Preclinical

Phase I

PHASE II/ PIVOTAL
Completed
15-096
Recurrent Osteosarcoma

Preclinical

Phase I

PHASE II/ PIVOTAL
Completed

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