Y-mAbs Therapeutics Inc. said the U.S. Food and Drug Administration granted rare pediatric disease designation for its experimental cancer treatment GD2-GD3 Vaccine.
The New York-based biotech is developing GD2-GD3 Vaccine for treating children with neuroblastoma, a kind of cancer that forms from immature nerve cells and usually begins in the adrenal glands. It typically impacts children younger than five.
GD2-GD3 Vaccine was originally developed by Memorial Sloan Kettering Cancer Center, a private company that engages in cancer prevention, treatment and research activities. The research center licensed the therapy to San Diego-based biotech MabVax Therapeutics Holdings Inc.
Y-mAbs licensed the drug from MabVax for treating neuroblastoma in 2018 and has the rights to commercialize the drug.
The FDA grants priority review vouchers to eligible companies following approval of treatments with a rare pediatric disease designation. The voucher can be redeemed to get an accelerated six-month review instead of 10 months for a future marketing application with the FDA. Y-mAbs will pay MabVax 20% of net income from the potential sale of a voucher, if granted.
Y-mAbs is evaluating the drug for safety and effectiveness in patients with neuroblastoma in a Phase 1/2 trial. The patients received seven injections within a year to prevent relapse. The company plans to start another midstage study of GD2-GD3 Vaccine in the same indication in 2020.
Earlier in December, Y-mAbs started a rolling submission of a biologics license application with the FDA for another therapy for neuroblastoma, called naxitamab, which treats cancer that has returned or has not responded to earlier treatment.