Concerns grow over cancer risks in Bluebird Bio’s gene therapy

Newly published data reveal that seven out of 67 children with treatment Bluebird Bio Inc (NASDAQ:BLUE) gene therapy for a serious neurological disorder in clinical trials has developed blood cancers.

That’s an increase of four cases since June 2022, when the emergence of three cancer cases prompted the FDA to convene an advisory panel before approving the therapy, now marketed as Skysona. The STAT News report noted that one child died of complications from cancer treatment.

Also read: Gene therapy-focused Bluebird restructures, cuts workforce by 25%, aims to break even next year

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

In September 2022, the FDA approved Bluebird bios Skysona, also known as eli-cel, to slow the progression of neurological dysfunction in boys aged 4 to 17 years with early active cerebral adrenoleukodystrophy (CALD).

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

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

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

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

Price action: At last check on Friday, shares of BLUE were trading 3.09% higher at $0.51 pre-market.

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This article worries about cancer risks in Bluebird Bio’s gene therapy originally appeared on Benzinga.com

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