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Clinical Trials of New Treatment for Advanced Melanoma In UK and USA

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IMCgp100 is the first clinical candidate originating from Immunocore’s ImmTAC technology platform and a new treatment could benefit many thousands of patients diagnosed with skin cancer each year.

Melanoma is a form of skin cancer that accounts for less than five per cent of cases but causes the vast majority of skin cancer deaths. The American Cancer Society estimates that 68,130 new melanomas will be diagnosed in the US during 2010 and 8,700 deaths from this disease will occur. 10,672 cases were diagnosed in the UK in 2007 and there were 2,067 deaths in 2008. Incidence rates for melanoma have increased in the last thirty years and, unlike other common cancers, melanoma has a wide age distribution.

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 leading 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 new investment to take additional programmes into the clinic.

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Non-specific T cells (blue) recognise and kill target melanoma cells (red) but ignore non-target cells (green) in the presence of the drug, IMCgp100

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Non-specific T cells (green) recognise and kill target melanoma cancer cells (red) in the presence of the drug, IMCgp100.

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 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. I am very excited to see the first candidate advance into clinical trials”.

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Dr Bent Jakobsen, founder and chief scientific officer of Immunocore, in the company’s laboratories at Milton Park, Oxfordshire

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.

“This is a novel approach to the challenge of mobilizing the immune system’s ability to recognise and disable cancer cells. In this study we will assess their effectiveness by analysing tumour samples from melanoma patients for evidence of local immune stimulation,” explains Professor Carl June, MD, director of translational research at the Abramson Family Cancer Research Institute (AFCRI) at Penn, which will conduct the US trial.

“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.”

Further details of both trials are available at www.clinicaltrials.gov.