bluebird bio to split into oncology and gene therapy specialists

US biotech bluebird bio has announced plans to split into two this year, with a separate oncology business spinning off as the company prepares to bring its products to market.

Under the plans the company’s rare disease drugs will remain under the aegis of bluebird with current genetic disease president Andrew Obenshain taking the reins as CEO.

Meanwhile the as-yet unnamed oncology company will spin off under the leadership of bluebird’s current chief executive Nick Leschly.

Leschly will also take the role of executive chair at bluebird, according to a company statement.

While bluebird has conducted pioneering work in gene therapy for blood disorders and in cancer cell therapy, products have been delayed by issues with filing data for the FDA.

Late last year, bluebird’s shares tanked after the FDA laid out additional manufacturing standards for its lead gene therapy product, Lentiglobin, in sickle cell anaemia that could hold up filing until late 2022.

Bluebird’s lead CAR-T cancer cell therapy idecabtagene vicleucel (ide-cel) was last year hit with an FDA refuse-to-file letter, which required additional data on chemistry, manufacturing and controls before reviewing the company’s dossier.

That made things difficult for development partner Bristol-Myers Squibb, which inherited the drug previously known as bb2121 through its acquisition of Celgene late in 2019.

The FDA is now due to make a decision on ide-cel as a treatment for multiple myeloma in late March.

Laying out the rationale for the spin-off, bluebird said that operating individually the two companies will be more effective at allocating capital.

The companies will be better equipped to deliver on goals and operations will be streamlined and simplified.

They will also be better at raising money with tailored investment theses and increased strategic flexibility.

The gene therapy firm will be focused on its most important therapies in beta-thalassemia, cerebral adrenoleukodystrophy and sickle cell disease in the US And Europe.

Zynteglo is already in beta-thalassemia in Europe, where the company will seek to expand access despite its hefty $1.8 million price tag.

On the oncology side, bluebird has also strengthened its board with the appointment of Dr Ramy Ibrahim, a high-profile leader in clinical development in immunotherapy and cell therapy.

Ibrahim is currently serving as a consultant for the Parker Institute for Cancer Immunotherapy (PICI) and built the clinical capabilities within the institute.

Ibrahim also worked as vice president and global therapeutic head for immuno-oncology at AstraZeneca and MedImmune, helping to develop the immunotherapy Yervoy (ipilimumab) at Bristol-Myers Squibb.

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