FDA Grants Orphan Drug Designation to Bivalent Vaccine for Neuroblastoma
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MabVax Therapeutics’ vaccine for the treatment of relapsed or recurrent high-risk neuroblastoma in remission or with limited residual disease after best available treatment. The bivalent vaccine is intended to elicit a targeted immune response against the two most common antigens on neuroblastoma cells, GD2 and GD3.
Results of a recent phase I published in Clinical Cancer Research demonstrated encouraging outcomes with the vaccine in a small cohort of patients with relapsed neuroblastoma. Antibody responses against GD2 and/or GD3 were observed in 12 of 15 patients, and disappearance of minimal residual disease was documented in 6 of 10 patients assessable for response.
A phase II trial is being planned for 2015.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
