Date: 2014-04-20
Type of information: Granting of the orphan status in the US
Product name: Tedopi® (OSE2101)
Compound: targeted cancer immune therapy (ten synthetic peptides targeting five tumor associated antigens)
Therapeutic area: Rare diseases - Cancer - Oncology
Action mechanism: immunotherapy product. Tedopi® (OSE2101) targets five tumour associated antigens (TAA), selected because their presence is linked to a poor prognosis and the severity of various cancers. Tedopi® contains ten optimized epitopes, or “neoepitopes”, designed on the binding of HLA-A2 and TCR. These neo-epitopes generate strong specific T cytotoxic responses that fight cancer and prevent tumour escape. These five tumor antigens (HER-2/neu, p53, CEA, MAGE-2 and MAGE-3) are expressed in various tumors related to poor prognosis and even poorer when associated.
Company: OSE Pharma (France)
Disease: non- small cell lung cancer (NSCLC) in patients expressing HLA-A2
Latest news: * On February 14, 2013, OSE Pharma SA, dedicated to severe orphan lung diseases has announced its phase III lead product, OSE 2101 a targeted cancer immune therapy (ten synthetic peptides targeting five tumor associated antigens) has been granted orphan drug status by FDA for the treatment of NSCLC in patients expressing HLA-A2.
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: 2013-02-14
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
