Claus Moller, CEO of Y-mAbs Therapeutics (YMAB), highlighted three of the company’s most
advanced candidates in today’s presentation. The company plans to submit Biologics License
Applications (BLAs) for naxitamab and omburtamab in 2019, and to submit an Investigational
New Drug (IND) application for two bispecific antibodies (BsAb).
For naxitamab, which is currently in Phase II trials for relapsed/refractory high-risk neuroblastoma
and osteosarcoma, the CEO stressed the therapy’s potential for addressing unmet needs due to
the modest toxicity of the drug, shorter infusion time, and ability to be administered in an
outpatient setting. Following the submission of the BLA in 2019, the company plans to
commercialize the product in the US, if approved.
As there are no approved therapies for patients with relapsed/refractory neuroblastoma suffering
from CNS/leptomeningeal metastases, there is a wide market opportunity for omburtamab.
Based on clinical studies in which the drug demonstrated an improvement in the overall survival
rate of patients, the company plans to submit a BLA in 2019.
The company’s BsAb platform was also briefly mentioned, which includes two antibodies
targeting GD2- and CD33-positive cancers, huGD2-BsAb, which is in a Phase I study for GD2-
positive solid tumours, and huCD33-BsAb for hematological malignancies, with a potential IND
submission planned for Q1 2020.
The presentation concluded with a brief overview of the company’s financial position. Y-mAbs
Therapeutics has raised $230m through a series of financing rounds with key investors such as
HBM, Scopia Captial, Sofinnova, and Nasdaq. The priorities for investment are going to be the
advanced candidates in today’s presentation. The company plans to submit Biologics License
Applications (BLAs) for naxitamab and omburtamab in 2019, and to submit an Investigational
New Drug (IND) application for two bispecific antibodies (BsAb).
For naxitamab, which is currently in Phase II trials for relapsed/refractory high-risk neuroblastoma
and osteosarcoma, the CEO stressed the therapy’s potential for addressing unmet needs due to
the modest toxicity of the drug, shorter infusion time, and ability to be administered in an
outpatient setting. Following the submission of the BLA in 2019, the company plans to
commercialize the product in the US, if approved.
As there are no approved therapies for patients with relapsed/refractory neuroblastoma suffering
from CNS/leptomeningeal metastases, there is a wide market opportunity for omburtamab.
Based on clinical studies in which the drug demonstrated an improvement in the overall survival
rate of patients, the company plans to submit a BLA in 2019.
The company’s BsAb platform was also briefly mentioned, which includes two antibodies
targeting GD2- and CD33-positive cancers, huGD2-BsAb, which is in a Phase I study for GD2-
positive solid tumours, and huCD33-BsAb for hematological malignancies, with a potential IND
submission planned for Q1 2020.
The presentation concluded with a brief overview of the company’s financial position. Y-mAbs
Therapeutics has raised $230m through a series of financing rounds with key investors such as
HBM, Scopia Captial, Sofinnova, and Nasdaq. The priorities for investment are going to be the
two pivotal stage candidates, their respective approvals and potential commercialization, as well
as continuing the expansion of potential indications for the lead candidates in ongoing studies.
as continuing the expansion of potential indications for the lead candidates in ongoing studies.
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