a cell-therapy biotech, founded by former NCI chief Rick Klausner, whose Gen-R and Epi-R technologies reprogram T cells to fight solid tumours

Lyell bet that its genetic and epigenetic T-cell reprogramming, paired with GSK's NY-ESO-1 work, would deliver 'cell therapy 2.0' for solid tumours.

$250M upfront from GSK in 2019, with billions more in potential milestones

GSK's then R&D head Hal Barron struck the Lyell alliance (dated 23 May 2019) with $250 million upfront and billions more in milestones, pointing the pharma giant at what he hoped was the front of the cell therapy 2.0 movement.

In August 2022 Lyell flagged that GSK had seen data from first-generation lete-cel (from Adaptimmune) in non-small cell lung cancer, had not observed the anticipated clinical activity and had stopped enrollment. Lyell's LYL132 had cleared an IND in January 2022; LYL331's had not yet been filed.

On 24 October 2022 GSK gave notice terminating its license and collaboration agreement with Lyell, effective 24 December 2022, ending LYL132, LYL331 and other second-generation approaches. A day later Adaptimmune said GSK was also dropping its NY-ESO and PRAME programs.

The alliance leaned on NY-ESO-1: when first-generation lete-cel data disappointed, the second-generation programs built on it lost their footing.

GSK's new R&D leadership said it would stop funding programs it lacked confidence would produce approved medicines and redirect the money.

Lyell's programs were early, with one IND cleared in January 2022 and one not yet filed, so there was no clinical data of their own to defend them.

The deal's champion, Barron, had left GSK's R&D helm a couple of months before the termination.

A flagship alliance can end in a day once its champion has left: deals built on one executive's conviction are the first a new R&D head re-underwrites.

As of 2022-10-25 the Lyell alliance was set to end on 24 December 2022. Lyell's founder Rick Klausner had earlier been replaced as CEO and had gone on, with Barron, to Altos Labs. Adaptimmune said it would focus on MAGE-A4 afami-cel, preparing a BLA in synovial sarcoma, and noted that lete-cel's registrational study in synovial sarcoma and MRCLS was due to read out the next year.

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  1. Updated: In broad retreat, GSK's new R&D leader abandons NY-ESO plans, pulls plug on cell therapy 2.0 alliances after losing faith endpoints.news