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Adaptimmune initiates Phase I/II metastatic melanoma drug trial

Adaptimmune has initiated an open label two cohort Phase I/II clinical trial to treat patients with metastatic melanoma.

The trial is intended to evaluate the safety, bioactivity and anti-tumor effect of patients’ own T cells that have been genetically modified to express a high affinity T cell receptor (TCR) specific for a type of tumor antigen (protein) known as a cancer testis antigen (CT antigen).

The company expects to recruit around 12 patients over a period of two years, with six patients participating in each of the NYESO-1 and MAGE-A3/6 cohorts in accordance with a genetic randomization scheme based on a patient’s HLA-A type and tumor antigen status.

The company aims to enhance response rates using gene-based personalized cell therapy that incorporates recent advances in vector design, TCR engineering, and the T cell manufacturing process.

Adaptimmune CEO James Noble said the potential of adoptive T cell therapy to effect impressive antitumor responses in melanoma patients is generally established.