The decision comes after strategic uncertainty regarding a review of preliminary clinical data from GSK’s lete-cel product candidate trial.
Lyell Immunopharma announced in an October 24, 2022, SEC filing that GlaxoSmithKline (GSK) had informed the company of the decision to terminate an agreement regarding its development of several investigational cell therapy products which target NY-ESO-1 and utilize Lyell’s genetic and epigenetic reprogramming technologies.1
The 2 companies originally entered into the agreement in 2019, which involved an upfront payment to Lyell of $250 million and potential future payments based on milestones. Two product candidates which incorporated Lyell’s technologies, LYL132 and LYL331,nhave been the early stages of development, with LYL132 having received clearance of its investigational new drug (IND) application early in 2022, and LYL331 not yet having any IND submitted.As such, safety and efficacy data for the candidates are not yet available. GSK made the decision to terminate the agreement based on strategic uncertainty regarding a review of preliminary clinical trial (NCT03709706) data of its lete-cel product candidate, which was being investigated for the treatment of non-small cell lung cancer. The lete-cel product did not incorporate Lyell’s technology.
The rights to the NY-ESO-1-targeted cell therapy candidates have now been fully transferred from GSK to Adaptimmune, along with GSK’s late-stage preclinical PRAME-targeted T-cell Receptor (TCR) candidates, as part of a 2014 agreement established between the 2 companies.2 Adaptimmune intends to determine the optimal pathway to further development of these programs. The company’s current lead product candidate targets MAGE-A4.
"MAGE-A4, NY-ESO, and PRAME are amongst the best-characterized and validated TCR T-cell targets in the solid tumor field,” Adrian Rawcliffe, chief executive officer, Adaptimmune, said in a statement regarding the news.2 “With full ownership of these affinity enhanced SPEAR T-cells against each of these targets, we will be able to bring the benefits of cell therapy to an even larger number of people with cancer. While we remain focused on the delivery of our flagship MAGE-A4 program, we are even better positioned with this portfolio to lead the field of engineered T-cells for the treatment of cancer well into the future."
GSK will continue to be a stockholder for Lyell, and Lyell announced that it does not expect the termination of the agreement will substantially affect its own operations.1It was noted that the agreement’s termination will formally go into effect on December 24, 2022.