Worries Mount Over Cancer Risks in Bluebird Bio's Gene Therapy

Newly released data reveals that seven out of 67 children treated with Bluebird Bio Inc's BLUE gene therapy for a severe neurological disorder in clinical trials have developed blood cancers.

This marks an increase of four cases since June 2022, when the emergence of three cancer cases led the FDA to convene an advisory panel before approving the therapy, now marketed as Skysona. The STAT News report noted that one child passed away due to complications from cancer treatment.

Also Read: Gene Therapy-Focused Bluebird Bio Restructures, Cuts Is Workforce By 25%, Seeks To Breakeven Next Year.

Researchers anticipate more cases of cancer could arise in the coming years and are conducting regular blood tests to monitor the patients.

In September 2022, the FDA approved Bluebird Bio's Skysona, aka eli-cel, to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD).

When in December 2023, the FDA approved Bluebird Bio's Lyfgenia (lovotibeglogene autotemcel (lovo-cel)) cell-based gene therapy for sickle cell disease, a black box warning was included in the label for Lyfgenia as hematologic malignancy (blood cancer) occurred in patients treated with Lyfgenia.

In April 2022, Bluebird Bio laid off about 30% of its workforce. The gene therapy-focused company is showing the exit to nearly one-third of its staff to extend its cash runway into the first half of 2023 and save $160 million over the next two years. 

Bluebird plans to reduce its workforce across the second and third quarters of 2022, the company revealed in an SEC filing. 

The biotech said it planned to spend less than $400 million in 2022.

Price Action: At the last check on Friday, BLUE stock was trading higher by 3.09% to $0.51 premarket.

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