GlaxoSmithKline (GSK) and Adaptimmune Therapeutics, a biopharmaceutical company focused on the use of T-cell receptor (TCR) engineered T-cell therapy to treat cancer, have expanded the terms of their strategic collaboration agreement to accelerate Adaptimmune's lead clinical cancer program, an affinity enhanced T-cell immunotherapy (GSK3377794) targeting NY-ESO-1 toward pivotal trials in synovial sarcoma.

Adaptimmune and GSK had announced a strategic collaboration and licensing agreement in June 2014 for up to five programs, including the lead NY-ESO TCR program. NY-ESO-1 is a well-characterized immunogenic cancer testis antigens, and is frequently expressed by tumors of different origins and in advanced tumors. The company' has trials in the NY-ESO-1 program in multiple myeloma, melanoma, sarcoma and ovarian cancer. GSK has an option on the NY-ESO- 1 program through clinical proof of concept, and, on exercise, will assume full responsibility for the program.

Under the terms of the expanded agreement, the companies will accelerate the development of Adaptimmune's NY-ESO therapy into pivotal studies in synovial sarcoma and will explore development in myxoid round cell liposarcoma. Additionally, the companies may initiate up to eight proof-of-principle studies exploring combinations with other therapies, including checkpoint inhibitors.

According to the expanded development plan, the studies will be conducted by Adaptimmune with GSK effectively funding the pivotal studies and sharing the costs of the combination studies via a success-based milestone structure. Previous guidance relating to the collaboration disclosed potential cash payments to Adaptimmune of approximately $350 million over the first seven years from 2014 in relation to NY-ESO and two further programs. Given the changes announced today, and the advances made across the collaboration, Adaptimmune is updating and expanding this disclosure. Under the terms of the expanded agreement, the potential development milestones Adaptimmune is eligible to receive solely in relation to the NY-ESO program could amount to approximately $500 million, excluding previously received payments, if GSK exercises its option and successfully develops NY-ESO in more than one indication and more than one human leukocyte antigen (HLA) type. In addition, Adaptimmune would receive tiered sales milestones and, as previously disclosed, mid-single to low double digit royalties on worldwide net sales. GSK has the right to nominate up to four additional targets in due course and Adaptimmune is eligible to receive further significant undisclosed milestone payments in relation to these earlier stage target programs.

Source: GlaxoSmithKline