GSK exercises option on phase I/II NY-ESO T-cell therapy (GSK3377794)
07 September 2017
Today GSK announced that it has exercised the option to obtain an exclusive global license from Adaptimmune for an investigational SPEAR T-cell receptor therapy targeting NY-ESO-1 (GSK3377794). Upon exercise of this option and transition of the programme, GSK will assume responsibility for all development, manufacturing and commercialisation activities for the asset.
Adaptimmune will receive up to £48 million from GSK over the course of the transition period. This includes development milestones of up to £18M and the option payment of £30 million, which also allows GSK to nominate two additional targets following completion of the transition. Successful continuation of development and subsequent commercialisation of GSK3377794 would trigger additional payments for development milestones, tiered sales milestones and mid-single to low double digit royalties on worldwide net sales.
Oncology is one of four Therapy Areas of focus for GSK’s R&D efforts, where the company believes there are significant opportunities for growth and innovation. GSK has three main areas of oncology research: cell and gene therapy; cancer epigenetics, and immuno-oncology. There is tremendous potential for cells to be engineered into medicines and GSK is investing broadly to develop platform capabilities in manufacturing cell and gene therapies for use across a broad range of disease areas, including oncology.
Axel Hoos, SVP Oncology R&D, GSK said “The aim of GSK’s R&D is to develop medicines with transformational potential for patients. We have seen compelling data for the NY-ESO investigational cell therapy in synovial sarcoma and, following this option exercise, we will capitalise on our in-house cell and gene therapy capabilities to support the development programme for GSK3377794. We will continue to explore the potential for this novel cell therapy in multiple tumour types, and in combination with other cancer therapies.”
James Noble, Chief Executive Officer of Adaptimmune, said “This is a very exciting day for Adaptimmune as GSK has exercised its option over our NY-ESO program, earlier than originally planned. The commitment by one of the world’s leading pharmaceutical companies to the NY-ESO SPEAR T-cell program as a new treatment modality is a testament to the strength of our data in synovial sarcoma recently presented at ASCO.”
GSK3377794 has been granted PRIME designation by the European Medicines agency and Breakthrough Therapy Designation by the US Food and Drug Administration. There are currently six ongoing phase I/II studies of GSK3377794 as monotherapy (non-small cell lung cancer, metastatic melanoma, ovarian, multiple myeloma, synovial sarcoma, and myxoid round cell liposarcoma) and one phase I study in combination with pembrolizumab in multiple myeloma. As part of the transition process, GSK will be developing a timeline for development activities, including initiation of new clinical studies.
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2016.