Immunocore Announces Clinical Trials of New Treatment for Advanced Melanoma in UK and USA
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Researchers at Immunocore Limited has announced that IMCgp100, a targeted therapeutic for the treatment of advanced metastatic melanoma, has received regulatory and ethics approval and has opened enrolment for clinical trials in the UK and USA. IMCgp100 is the first clinical candidate originating from Immunocore’s innovative ImmTAC technology platform and a new treatment could benefit many thousands of patients diagnosed with skin cancer each year.
Patients who are diagnosed early are treatable with surgical resection, although in many the disease will recur within a few years. If melanoma continues to the late stages and becomes metastatic the prognosis is poor, with average survival times of six to nine months. Chemotherapy is the most common treatment, but the response rate is very low so there is a high level of unmet need for more effective therapies.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) Medicines Division has approved a Phase 1 dose finding study in patients with advanced malignant melanoma. The two-part study will 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.
Recruitment for the clinical trial has commenced at three hospitals in Oxford, Cambridge and Birmingham and the first patient has received treatment.
Professor Mark Middleton of the NIHR Biomedical Research Centre, Oxford said: “We need new treatment options for patients with metastatic melanoma that not only extend lives but also improve quality of life. This clinical trial will generate the first data on this promising novel reagent IMCgp100”.
Immunocore’s ImmTAC technology platform builds on expertise with high affinity 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. IMCgp100 is the first product in the pipeline to enter a clinical trial and the company has recently secured significant investment to take additional programmes into the clinic.
Dr Bent Jakobsen, founder and chief scientific officer of Immunocore, said: “We have worked for over ten years trying to overcome immune tolerance to cancer. Tumour cells often express only very low levels of their signature antigens and thereby hide from the immune system. We take human T cell receptors which recognize 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. I am very excited to see the first candidate advance into clinical trials”.
In the USA, the Food and Drug Administration (FDA) has approved a Phase 0 or Exploratory Trial. This study, 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.
“The number of melanoma cases in the US is increasing and although early-stage melanoma can be treated surgically, we urgently need effective therapies to manage late stage metastatic disease,” notes Leslie Fecher MD, assistant professor of Medicine and principal investigator on the trial. “As a novel targeted immunotherapy, IMCgp100 may be a promising new approach to tackle this intractable disease.”
Patients who are diagnosed early are treatable with surgical resection, although in many the disease will recur within a few years. If melanoma continues to the late stages and becomes metastatic the prognosis is poor, with average survival times of six to nine months. Chemotherapy is the most common treatment, but the response rate is very low so there is a high level of unmet need for more effective therapies.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) Medicines Division has approved a Phase 1 dose finding study in patients with advanced malignant melanoma. The two-part study will 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.
Recruitment for the clinical trial has commenced at three hospitals in Oxford, Cambridge and Birmingham and the first patient has received treatment.
Professor Mark Middleton of the NIHR Biomedical Research Centre, Oxford said: “We need new treatment options for patients with metastatic melanoma that not only extend lives but also improve quality of life. This clinical trial will generate the first data on this promising novel reagent IMCgp100”.
Immunocore’s ImmTAC technology platform builds on expertise with high affinity 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. IMCgp100 is the first product in the pipeline to enter a clinical trial and the company has recently secured significant investment to take additional programmes into the clinic.
Dr Bent Jakobsen, founder and chief scientific officer of Immunocore, said: “We have worked for over ten years trying to overcome immune tolerance to cancer. Tumour cells often express only very low levels of their signature antigens and thereby hide from the immune system. We take human T cell receptors which recognize 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. I am very excited to see the first candidate advance into clinical trials”.
In the USA, the Food and Drug Administration (FDA) has approved a Phase 0 or Exploratory Trial. This study, 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.
“The number of melanoma cases in the US is increasing and although early-stage melanoma can be treated surgically, we urgently need effective therapies to manage late stage metastatic disease,” notes Leslie Fecher MD, assistant professor of Medicine and principal investigator on the trial. “As a novel targeted immunotherapy, IMCgp100 may be a promising new approach to tackle this intractable disease.”
