The US Food and Drug Administration has granted Immunocore’s IMCgp100 orphan drug designation for the treatment of uveal melanoma.

The move qualifies the UK biotech for a number of development incentives and will enable a fast-track registration for the drug, which is currently in Phase IIa clinical trials for the treatment of late stage cutaneous and uveal melanoma.

The firm is hoping that IMCgp100, its most advanced ImmTAC (Immune mobilising mTCR Against Cancer), will offer patients the first treatment for the debilitating condition, and says the orphan drug designation gives it the opportunity to fast-track the programme.

Immunocore's ImmTACs are a new class of drug with ultra-high affinity for intracellular cancer targets, which enable the immune system to recognise and kill cancerous or bacterially/virally infected cells. 

The news comes just days after the group announced that it has started a Phase Ib/II trial assessing IMCgp100 in combination with MedImmune’s investigational therapies durvalumab and tremelimumab for the treatment of metastatic cutaneous melanoma.


The open label, four arm trial is exploring IMCgp100 paired respectively with durvalumab and tremelimumab as well as investigating all three immunotherapy agents together.