Adaptimmune to lay off up to 30% of staff as allogeneic ambitions stunted by cell line change

At the beginning of August, preparations for Adaptimmune’s allogeneic MAGE-A4 program seemed to be near the finish line, with the company’s UK manufacturing facility almost done. The plan at the time was for the cell therapy to be ready for trial applications by next year.

But that timeline is now up in flames. The company announced Tuesday that it's decided to switch up the cell line used for the off-the-shelf therapy after a “chromosomal abnormality” was identified in the original batch. That move has pushed back the expected clinical trial readiness of the program by two years, now slated for 2025. 

It’s the most significant update among a flurry of pipeline amendments Adaptimmune disclosed as part of its third-quarter earnings report, which was capped off with the company deciding to lay off up to 30% of staff to extend its cash runway into 2025. The cuts are expected to be completed in the first quarter of 2023. 

The moves come as Adaptimmune is trying to charge ahead with an approval application for its autologous, genetically modified T-cells—"afami-cel"—to treat synovial sarcoma. The company reported a positive pre-submission meeting with the FDA in which regulators conveyed that Adaptimmune had a clinical case worthy of submission. The company intends to begin the rolling submission process in the fourth quarter with the goal of completing the application by the middle of 2023. 

But Adaptimmune will also delay investment in commercializing afami-cel as the rolling submission process plods along. The company will update its plans for a commercial launch date once the application has been submitted.

Beyond bringing afami-cel to market, Adaptimmune is prioritizing a series of trials called SURPASS in patients with ovarian, urothelial, and head & neck cancers in addition to the PRAME TCR program just acquired from GSK in October. The company hopes to have the PRAME asset ready for clinical trials in 2023 while GSK is responsible for phase 2 data of a separate NY-ESO-targeting program acquired by Adaptimmune that's slated to readout in late 2023. 

With its priorities clearly outlined and cash dwindling, Adaptimmune had to make cuts elsewhere. The company says it's ending one of the SURPASS trials in patients with gastroesophageal cancers and is culling its tumor-infiltrating lymphocytes IL-7 program. The company had previously submitted a clinical trial application for the IL-7 program in Denmark, with the hope that the single-site study would start this year. 

The pipeline and staffing reductions come as Adaptimmune’s financial reserves dry up. The company has spent almost half of its available cash and equivalents entering 2022, with $79 million still available. And the layoffs are thought to only extend that runway an additional year, with the current forecasting showing enough money to last into early 2024.