IMCnyeso

Unassigned

New Medicines

Solid tumours, NY-ESO-1- and/or LAGE-1A-positive

Information

Advanced therapy medicinal product (ATMP)
GlaxoSmithKline
GlaxoSmithKline

Development and Regulatory status

Phase II Clinical Trials
None
Phase II Clinical Trials

Category

An ImmTAC (immune mobilising monoclonal T-cell receptors against cancer) molecule. The immunotherapy comprises of a soluble, affinity-enhanced T-cell receptor (TCR) specific for human leukocyte antigen A2 (HLA-A2)-restricted cancer-testis antigens (CTAs)
Variable depending on tumour type. CTAs, NY-ESO-1 and LAGE-1A, are expressed on tumour cells. Expression frequency of NY-ESO-1 differs greatly with the most commonly expressing tumours being myxoid and round cell liposarcoma (89–100%), neuroblastoma (82%), synovial sarcoma (80%), melanoma (46%), and ovarian cancer (43%) [1].
Solid tumours, NY-ESO-1- and/or LAGE-1A-positive
Intravenous infusion

Trial or other data

Jan 20 · PI/II study (NCT03515551) is recruiting [2].
Jun 18 · PI/II trial to evaluate the safety and efficacy of IMCnyeso in patients with melanoma, non-small cell lung cancer, urothelial carcinoma and synovial sarcoma starts (IMCnyeso-101; NCT03515551). This is a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for NY-ESO-1 and/or LAGE-A1. 63 adults will be enrolled in the US, Canada and UK. UK sites are Sarah Cannon Research Institute, The Christie and The Royal Marsden. Primary outcomes include dose-limiting toxicities and best overall response. The study is due to complete Dec 20 [2].