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news.Immunocore's IMCgp100, a targeted therapeutic for the treatment of advanced metastatic melanoma, has received regulatory and ethics approval and has initiated enrollment for clinical trials in the UK and US.
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IMCgp100 is the first clinical candidate originating from Immunocore’s ImmTAC technology platform which builds on expertise with T cell receptors and has the potential to target a range of cancer and chronic viral diseases that are not accessible to conventional monoclonal antibodies.
The Medicines and Healthcare products Regulatory Agency (MHRA) Medicines Division in UK has approved a Phase 1 dose finding study in patients with advanced malignant melanoma.
The US Food and Drug Administration (FDA) has approved a Phase 0 or Exploratory Trial in which the drug will be injected directly into melanoma tumours, is designed to complement the UK study by shedding light on how the drug works, and at what concentration.
Immunocore said that the two-part study is expected to establish a tolerable intravenous dose of IMCgp100 and then assess the effect of this dose on pharmacodynamic markers when given repeatedly to a larger group of patients.
Immunocore founder and chief scientific officer Bent Jakobsen said that they take human T cell receptors which recognise specific cancer antigens, in this case gp100 for melanoma, and enhance their binding affinity so that they can target the cancer cells.
“The engineered T cell receptor is bound to an antibody fragment that redirects T cells to destroy the bound tumour cell,” Jakobsen said.
Abramson Family Cancer Research Institute (AFCRI) at Penn Translational Research director Carl June said that in this study they would assess their effectiveness by analysing tumour samples from melanoma patients for evidence of local immune stimulation.