Autolus delays multiple CAR-T clinical programs

FierceBiotech | August 09, 2019

A manufacturing delay is stymying progress of a clutch of Autolus CAR-T programs. Autolus revealed the setbacks alongside news that it is dumping the first-generation version of AUTO2 in the face of tough competition in the BCMA space. The manufacturing issue, which is affecting three Autolus programs, relates to a five-month delay in the timeline for qualifying the U.Ks Cell Therapy Catapult. Autolus clinical trial manufacturing site at Catapult was licensed in March and has supplied materials to studies since then. But the ramp-up of output has been slowed by delays at the broader Catapult complex. “The Cell Therapy Catapult site is a brand-new facility. And the challenge that we're seeing with the facility is a delay on the construction and qualification of the main facility. That actually basically resulted in a situation where the delay in the buildup and the construction of facility had a knock-on effect on our own ability to get our own suite that we're operating fully licensed and operational,” Autolus CEO Christian Itin said on a second-quarter results conference call with investors. Those delays pushed back overall qualification of the Catapult by five months. Itin said Autolus was able to claw back some of the lost time but still faces delays to multiple clinical trials programs. Autolus now plans to start the phase 2 portion of a trial of CD19xCD22 dual-CAR-T therapy AUTO3 in the second quarter of 2020. The phase 2 was due to get underway before the end of 2019. AUTO4 and AUTO5 have suffered similar delays. Autolus pushed back initial phase 1 data on AUTO4, a TRBC1-targeting CAR-T, from the first quarter of 2020 into the second half of the year. AUTO5 is now due to enter the clinic in the second half of 2020.

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Spotlight

The 2019 Healthcare Leadership Intelligence Survey reveals the demand for experienced healthcare executives has never been higher as organizations seek leaders who can navigate a wide range of challenges. Many executives are viewing these challenges as opportunities to display strong leadership and leave a lasting impression on their organizations, staff, patients, and communities. This infographic highlights findings from B.E. Smith’s 2019 Healthcare Leadership Intelligence Survey.

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