- Autolus Therapeutics plc's AUTL Phase 2 pivotal FELIX trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukemia (ALL) has met its primary endpoint of Overall Remission Rate (ORR).
- The data comes from a pre-planned interim analysis of 50 patients.
- The ORR for obe-cel was 70%. Obe-cel showed comparable expansion and initial persistence (median follow-up 6.4 months) to the data observed in the prior ALLCAR19 study.
- The safety analysis was based on 92 patients treated with obe-cel and evaluable for safety.
- The company observed that 3% of patients experienced Grade 3 or higher CRS, 8% experienced Grade 3 or higher ICANS, and 23% experienced any grade ICANS.
- Autolus plans to present the results from the FELIX trial, with a longer follow-up planned to be reported at the end of 2023.
- Blackstone Life Sciences has committed two pre-agreed milestone payments of $70 million to Autolus due to the interim analysis of the FELIX Phase 2 trial.
- Concurrently, Autolus has priced 75 million ADSs representing 75 million shares at $2.00 per ADS, for total gross proceeds of $150 million.
- Underwriters have the option to purchase up to an additional 11.25 million ADSs.
- Price Action: AUTL shares closed 29.10% lower at $2.12 during premarket trading on the last check Friday.
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