Syncona's Autolus gets FDA approval for leukaemia treatment

The FTSE 250 company said it marked a significant milestone for Autolus, an early-commercial biopharmaceutical firm focused on advancing T-cell therapies for cancer.

It said the FDA’s approval of Aucatzyl was based on data from the ‘FELIX’ clinical trial, which demonstrated a strong safety profile for obe-cel.

Notably, Aucatzyl was the first CAR T-cell therapy in this category to receive approval without a requirement for a risk evaluation and mitigation strategy, an FDA-imposed safety programme often mandated for treatments with serious risks.

The FELIX trial showed that among 65 evaluable patients, 63% achieved complete remission, with 42% achieving complete remission within three months and a median remission duration of 14.1 months.

Syncona noted that the approval is set against the backdrop of poor outcomes for patients with r/r B-ALL, an aggressive blood cancer with low survival rates and a median survival of just eight months for adults.

Around 8,400 new cases of ALL are diagnosed annually in the US and the European Union, with around 3,000 of those in the relapsed refractory category.

Aucatzyl would be manufactured at Autolus' facility in Stevenage, UK, with global distribution planned, marking a key step in scaling the company’s therapeutic offerings.

“We are delighted for Autolus to receive FDA approval for its novel CAR T-cell therapy for the treatment of adult ALL,” said Chris Hollowood, chief executive officer of Synona Investment Management.

“Adult ALL is a devastating disease and Aucatzyl will bring a much-needed new treatment option to patients suffering from the condition.

“This is a proud moment for Syncona - we co-founded Autolus in 2014 and it is the first company we have supported from the academic bench through to regulatory approval.”

At 0801 GMT, shares in Syncona were up 0.9% at 112p.

Reporting by Josh White for Sharecast.com.