Date: 2014-09-23
Type of information: Granting of the orphan status in the US
Product name: MV-NB-02 - bivalent ganglioside vaccine consisting of GD2-lactone and GD3-lactone each covalently conjugated to keyhole hemocyanin
Compound: bivalent ganglioside vaccine consisting of GD2-lactone and GD3-lactone each covalently conjugated to keyhole hemocyanin
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: therapeutic vaccine. MV-NB-02 is a bivalent vaccine that elicits an antibody response targeting the two most common antigens on neuroblastoma cells with the objective of killing residual cancer cells that can cause recurrence. A phase I trial has already been conducted at Memorial Sloan-Kettering Cancer Center. MabVax intends to initiate a clinical trial utilizing the neuroblastoma vaccine in 2015.
Company: MabVax Therapeutics (USA - CA)
Disease: neuroblastoma
Latest news: * On September 23, 2014, the FDA has granted orphan drug designation for MV-NB-02, bivalent ganglioside vaccine consisting of GD2-lactone and GD3-lactone each covalently conjugated to keyhole hemocyanin for the treatment of neuroblastoma.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2014-09-23
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
