Autolus obe-cel in lupus, phase 1: DORIS remission in all patients with 6+ months of follow-up
In the phase 1 CARLYSLE trial of 15 patients, Autolus reported SLEDAI-2K improvement and DORIS remission at 6+ months. The sample is small; phase 2 data are expected in 2028.
Autolus Therapeutics presented extended follow-up data for its cell therapy obe-cel in severe, treatment-resistant lupus at the ACR Convergence 2026 rheumatology congress, ad-hoc-news.de reports. The data came on the same day as the company's quarterly results. The drug is so far approved only for leukemia. ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗
CARLYSLE trial: efficacy and safety
The phase 1 CARLYSLE trial includes 15 treated patients, three of them adolescents. Follow-up in adults extends up to 25 months. In all patients observed for at least six months, the SLEDAI-2K disease activity index improved markedly and they met the DORIS remission standard.
In lupus nephritis, kidney involvement of the disease, six of nine patients with at least six months of follow-up achieved a complete renal response. No severe renal flares occurred.
No ICANS neurotoxicity and no HLH-like syndrome were observed, nor any cytokine release syndrome of grade 3 or higher. B cells recovered after a median of four to seven months, mostly with a naive phenotype. ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗ The number of patients remains small. The phase 2 trial LUMINA is to provide more robust data, which the company expects in 2028.
Quarterly results and pipeline
Net revenue from the leukemia drug Aucatzyl rose by 95 percent to 41.2 million dollars, above expectations. Gross margin increased to 57 percent. Management raised its outlook: full-year Aucatzyl revenue is now expected at the upper end of the previous 150 million dollars or above.
Loss per share was 0.21 dollars, slightly higher than analysts expected. Net loss fell to 55.1 million dollars from 79.1 million in the year-earlier quarter. Cash rose to 248.4 million dollars, helped by a credit line from Perceptive, and is expected to last into the second quarter of 2028.
In December 2026, Autolus plans to show first data on AUTO8 in light chain amyloidosis at the ASH congress. For progressive multiple sclerosis, the company is postponing its first data presentation to October 2027 after feedback from specialists. By then, at least twelve months of follow-up are expected for the first twelve patients. ad-hoc-news.de
ad-hoc-news.dead-hoc-news.deOpen source ↗
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