Bluebird Bio Slashes Workforce as It Awaits Key FDA Gene Therapy Decisions
The biotechnology company previously pulled out of Europe after encountering payor challenges for their gene therapies.
After weeks of financial uncertainty and executive shakeups, bluebird bio has announced that it will be cutting its workforce by 30% in order to extend its cash runway into 2023 as it awaits 2 key FDA decisions on its promising gene therapy candidates, betibeglogene autotemcel (beti-cel) and elivaldogene autotemcel (eli-cel).
Citing the “tough biotech market,” bluebird CEO Andrew Obenshain said, “today, we are taking decisive action to extend our cash runway, and put bluebird in a stronger position to execute on our strategic priorities and ultimately bring potentially curative gene therapies to patients and their families. The decision to reduce our workforce in support of a more focused set of priorities was not taken lightly, and we are grateful to every bluebird who has helped to progress the field of gene therapy and championed our mission.”
The restructuring plan will provide up to $160 million in cost savings over the next 2 years, according to the company, which hopes to reduce its cash burn to less than $340 million in 2022. The layoffs, which will affect a broad swath of bluebird’s 500-plus employees, will especially be felt in its research, product differentiation, launch preparation, and general administrative teams. The layoffs will ultimately cost bluebird approximately $10 million.
The restructuring will focus bluebird bio’s resources on its 2 gene therapies that are currently under review by the FDA: beti-cel for treatment of transfusion-dependent β-thalassemia, which has a PDUFA date of August 19, 2022; and eli-cel for the treatment of cerebral adrenoleukodystrophy (CALD), which has a PDUFA date of September 16, 2022. The decision dates reflect the recent extensions imposed by the regulatory agency, which cited the need for additional time to review new clinical information received from bluebird in response to previous information requests. If approved, the therapies will be the first lentiviral vector gene therapies available for patients with severe genetic diseases.
In addition, bluebird will continue to focus on its development of lovotibeglogeneautotemcel (lovo-cel) for the treatment of sickle cell disease. The clinical program was hit with a hold in late 2021 after a trial participant developed persistent anemia. In March 2022, bluebird announced that its plans to submit the biologics license application for lovo-cell remains on track for Q1 2023 despite the ongoing hold. The company recently dosed its final patient in the phase 1 /2 open-label HGB-206 study, which includes 45 patients treated with lovo-cel.
Notably, bluebird stated that it will deprioritize its efforts to develop less harsh conditioning regimens and cryopreserved apheresis.
Both beti-cel and eli-cel, which remains under clinical hold, will be the subject of a 2-day FDA AdComm meeting taking place June 9-10, 2022.
