YmAbs reveals breakthrough status after ten-fold survival rate increase

The US Food and Drug Administration has granted Breakthrough Therapy status to burtomab, an anticancer agent discovered by the cancer center at Memorial Sloan Kettering.

The drug is being developed under license by Denmark's Y-mAbs Therapeutics, which announced positive top-line data recently at the annual meeting of the American Society of Clinical Oncology (ASCO).

The company’s pivotal study in neuroblastoma showed a 58 months average survival rate for patients treated with the drug, compared to an average of 4.7 months for a contemporary cohort in the Central German Childhood Cancer Registry.

Y-mAbs founder Thomas Gad said: “We are very pleased that the FDA has granted the Breakthrough Therapy designation to burtomab and thereby shortened the timelines for making this therapy available to the children facing an unmet medical need.”

Y-mAbs is a Danish biotech firm formed in 2015 by former senior managers at Genmab (OMX: GEN), which focuses on novel immunotherapies for cancer.

The company has a proprietary platform to create next-generation humanized, affinity matured bispecific antibodies targeting GD2 and B7H3.