GSK has axed its NY-ESO-1 T-cell receptor (TCR) pact with Lyell Immunopharma, with the Big Pharma transferring the program to Adaptimmune. It means that months after stopping enrollment in a study of its first-generation NY-ESO-1 candidate, GSK has walked away from a $1 billion-plus pact with Lyell that could have delivered enhanced successors.
Lyell partnered with GSK in 2019, securing $45 million upfront and putting itself in line to receive more than $1 billion in milestones to apply its technologies to T-cell therapies. GSK’s interest in Lyell reflected the potential for the technologies to improve the depth and durability of clinical responses. But, over the summer, Lyell warned the partnership faced “new uncertainty” because GSK had stopped enrollment in a clinical trial of a first-generation NY-ESO-1 candidate after it delivered lackluster data.
The first-generation candidate, the Adaptimmune-originated lete-cel, doesn’t incorporate any of Lyell’s reprogramming technologies, but the phase 1/2 non-small cell lung cancer (NSCLC) data have seemingly led GSK to reassess its broader work on NY-ESO-1. In a Securities and Exchange Commission filing, Lyell said its understanding is that the strategic review sparked by the lete-cel data led to GSK’s decision to terminate the partnered programs, LYL132 and LYL331.
The winner from this decision appears to be Adaptimmune, which announced in a separate release today that it had gained possession of NY-ESO and another TCR T-cell program called PRAME. The terms of the deal for this programs are still being negotiated, the company added.
The collaboration between Adaptimmune and GSK dates back to 2014, when the companies agreed to look at up to five programs, with the first being NY-ESO, which GSK then exclusively licensed three years later. The PRAME program also sprung from this collaboration, and Adaptimmune said today that it expects the candidate to be submitted to begin clinical trials next year.
Adaptimmune will continue to prioritize its lead MAGE-A4 franchise while determining the "optimal development path for complementary PRAME and NY-ESO assets," the company added.
News of GSK’s axing of the Lyell deal and the transfer of the program to Adaptimmune comes in the wake of the departure of R&D chief Hal Barron, M.D., the executive at the Big Pharma who was closely linked to the original 2019 agreement. GSK, which bought a $58.6 million stake in Lyell as part of the 2019 deal, remains a significant shareholder in the biotech.
The implications, if any, of GSK’s strategic review for lete-cel are currently unclear. Adaptimmune is yet to make a financial regulatory filing, although its most recent quarterly submission also lacked details of GSK’s decision to stop enrollment in the lete-cel trial. GSK has an exclusive license to the candidate, and the NSCLC trial is listed as continuing to track existing participants.