On December 8, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that Blackstone Life Sciences (‘Blackstone’) has committed to make two pre-agreed milestone payments of $35m each to Autolus, totaling $70m (Press release, Autolus, DEC 8, 2022, View Source [SID1234625453]). The milestones are expected to be recognized in Autolus’ Q4 2022 cash balance.
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The first Blackstone milestone of $35m is being paid earlier than anticipated as a result of the joint steering committee’s review of Autolus’ interim analysis of pivotal FELIX Phase 2 clinical trial of obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukemia (ALL). The study has met its primary endpoint, the details of which have been announced in a separate press release today.
The second Blackstone milestone of $35m is a pre-agreed manufacturing milestone as a result of completion of planned activities demonstrating the performance and qualification of Autolus’ obe-cel’s manufacturing process.
"Receiving these two $35m milestone payments highlights the continuing strength and collaborative nature of our partnership with Blackstone," said Dr. Christian Itin, CEO of Autolus. "We are delighted to have demonstrated the potential merits of obe-cel’s clinical profile and our evolving robust manufacturing process to the Blackstone team, and look forward to continued progress together as we focus on our goal of submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) by the end of 2023."
"We are pleased with Autolus’ progress —we continue to believe obe-cel has the potential to become a transformative therapy for relapsed/refractory adult ALL patients," said Nicholas Simon, Senior Managing Director with Blackstone Life Sciences. "Our investments in these next generation cell therapies with Autolus exemplifies our conviction in the quality and promise of the life sciences sector in the UK."
As previously announced, Autolus and Blackstone entered into a strategic collaboration and financing agreement in November 2021, whereby funds managed by Blackstone agreed to provide up to $250 million in equity and product financing to support Autolus’ advancement of obe-cel, its CD19 CAR T cell investigational therapy product candidate, as well as next generation product candidates of obe-cel in B-cell malignancies.