Another bluebird bio executive is jumping ship. Chief Medical Officer David Davidson is leaving the company on April 16.
Another bluebird bio executive is jumping ship. Chief Medical Officer David Davidson is leaving the company on April 16.
Investors are reacting negatively to the announcement. The company stock, which has been on a steady decline for the past several months, was down more than 3% in premarket trading.
Davidson’s departure, which was announced in a filing with the U.S. Securities and Exchange Commission, comes at a rocky time for bluebird, particularly after its sickle cell gene therapy program LentiGlobin was placed on clinical hold by the U.S. Food and Drug Administration (FDA) and the company positions itself to split into two entities.
Davidson has served as bluebird CMO since 2012. Prior to that time, he spent nearly nine years in various leadership roles at Genzyme. After stepping down as CMO, Davidson will remain with the company as a consultant for six months in order to provide the company ongoing guidance and support for bluebird’s late-stage development programs in severe genetic disease.
In particular, bluebird said Davidson’s experienced hand will be needed as it navigates the “regulatory interactions” following the safety events with LentiGlobin.
In February, bluebird’s Phase I/II study of LentiGlobin was placed on hold due to the AML issue in one patient. Another patient in the study developed myelodysplastic syndrome, a disorder caused by poorly-formed blood cells. After weeks of investigating the incident, bluebird announced earlier this month that its lentiviral vector BB305 was unlikely to be the cause of the AML diagnosis in that patient.
While the AML diagnosis does not appear to have been caused by LentiGlobin, bluebird is still assessing the case of myelodysplastic syndrome. The company is in talks with the FDA to determine if it can resume its SCD trial.
Davidson’s decision to step down as CMO also comes at a time when bluebird was planning to split its company into two separate businesses. As BioSpace previously reported, “chief bluebird” Nick Leschly will head the Oncology Newco as chief executive officer and become executive chair for bluebird bio.
Andrew Obenshain, who currently helms the genetic disease business, will become CEO of bluebird bio. The company decided a split was the correct course for bluebird following a strategic review.
Bluebird is also awaiting a regulatory decision on its ide-cel treatment for multiple myeloma co-developed with Bristol Myers Squibb. Ide-cel, a CAR-T treatment that will serve as a cornerstone of the new bluebird oncology business, could receive regulatory approval by the end of March.
Data from clinical studies showed deep and durable responses with ide-cel treatment in patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Davidson’s announced departure also comes one day after startup Be Biopharma announced Joanne Smith-Farrell was tapped as chief executive officer. Prior to joining B cell-focused Be Biopharma, Smith-Farrell served as chief operating officer and business unit head of oncology at bluebird bio.
According to the SEC filing, Davidson will continue to receive his base salary for a period of 12 months and bluebird will pay the monthly employer contribution until 2022, or an earlier termination of his consulting agreement with the company.
