Syncona Ltd announced on Monday that the US Food & Drug Administration has granted marketing approval to one of its portfolio companies for a new product.
The life science investor said investee, Autolus Therapeutics - a biopharmaceutical company specialising in next-generation programmed T cell therapies - has received FDA marketing approval for Aucatzyl, a treatment for adult patients with relapsed aggressive blood cancer, specifically acute lymphoblastic leukaemia.
Syncona said approval of Aucatzyl was based on results from the Felix clinical trial, which confirmed a strong safety profile compared to current therapies and will not require carrying out a risk evaluation and mitigation programme, implemented for drugs with serious safety concerns.
In the Felix trial, 63% of the 65 patients eligible for assessment achieved complete remission, with 42% reaching remission within three months and a median remission duration of 14.1 months.
Acute lymphoblastic leukaemia is an aggressive type of blood cancer, with approximately 8,400 new cases annually in the US and EU, including around 3,000 patients in the relapsed refractory stage. Survival rates are very poor, with a median overall survival of eight months.
Aucatzyl will be produced at Autolus’ manufacturing site in Stevenage, UK, for global distribution.
Syncona’s Chief Executive Officer Chris Hollowood said: ‘We are delighted for Autolus to receive FDA approval for its novel CAR T-cell therapy for the treatment of adult ALL. 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.’
Syncona shares were 1.0% higher at 112.09 pence each on Monday morning in London.
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