GlaxoSmithKline (GSK) and Adaptimmune said today they have expanded their year-and-a-half-old collaboration agreement to speed up development of Adaptimmune’s lead clinical cancer program.
Under the original collaboration, Adaptimmune stood to gain approximately $350 million over seven years starting in 2014, in relation to NY-ESO and two additional programs. The expansion will raise the amount that Adaptimmune could generate by licensing its lead program to GSK from a potential $350 million-plus to about $500 million-plus.
Adaptimmune’s lead program is an affinity enhanced T-cell immunotherapy (GSK3377794) targeting the cancer testis antigen NY-ESO-1. The company said it has generated “encouraging results” in NY-ESO-1 trials assessing the immunotherapy in multiple myeloma, melanoma, sarcoma, and ovarian cancer.
“With this expanded collaboration, we have the opportunity to accelerate the lead program in synovial sarcoma toward pivotal trials and also to investigate several other tumor types and combine the T-cell therapy with immune-modulating therapies such as checkpoint inhibitors,” Axel Hoos, M.D., Ph.D., GSK’s svp, oncology R&D, said in a statement.
In addition to the pivotal studies in synovial sarcoma, the companies agreed to explore development of Adaptimmune’s NY-ESO therapy in myxoid round cell liposarcoma. GSK and Adaptimmune also agreed to launch up to eight proof-of-principle studies exploring combinations with other therapies, including checkpoint inhibitors.
Adaptimmune agreed to conduct the studies while GSK agreed to “effectively” fund the pivotal studies and share the costs of the combination studies through payments tied to achieving milestones.
The NY-ESO therapy was among up to five programs that GSK agreed to license from Adaptimmune when they launched their collaboration in June 2014.
GSK has an option on the NY-ESO-1 program through clinical proof of concept. Should GSK exercise that option and successfully develop NY-ESO in more than one indication and more than one Human Leukocyte Antigen type, Adaptimmune could receive up to $500 million in payments tied to achieving milestones—plus tiered sales milestones, in addition to previously disclosed royalties in the mid-single to low-double digits on worldwide net sales.
Adaptimmune said the expanded agreement would not change its earlier guidance to investors on rate of capital spending or “cash burn,” For all of 2016, the company said it expects a cash burn of between $80 million and $100 million, excluding cash burn associated with business development activities.
Adaptimmune added that it expects to finish 2016 with at least $150 million in cash, cash equivalents, and short-term deposits.
“If we succeed in generating pivotal data consistent with that of our ongoing studies, we believe it has the potential to be the first engineered T-cell therapy to reach the market,” added Adaptimmune CEO James Noble.