Bluebird bio reported first-quarter earnings, the approval of Abecma, the first CAR-T therapy for relapsed or refractory multiple myeloma, and its spinout, 2seventy bio, and its leadership.
Bluebird bio reported first-quarter earnings, touting the quarter’s approval of Abecma, the first CAR-T therapy for relapsed or refractory multiple myeloma, and the new name of its spinout, 2seventy bio, and its leadership.
On March 29, bluebird bio and its partner Bristol Myers Squibb announced the U.S. Food and Drug Administration (FDA) had approved Abecma (ide-cel), the first BCMA-targeted CAR-T therapy. It came with some limitations and is only recommended as a fifth-line treatment.
Nonetheless, Nick Leschly, chief bluebird, stated, “Undoubtedly the highlight of last quarter at bluebird was the approval of Abecma, the first and only CAR-T therapy approved for the treatment of relapsed or refractory multiple myeloma. We and our colleagues at BMS are now full speed ahead and on track to begin treating patients this quarter. It has been an amazing journey and in many ways, we’re just getting started.”
Earlier, on February 24, the FDA shifted the company’s voluntary pause on LentiGlobin gene therapy for sickle cell disease into an official clinical hiatus. Two patients in the trial developed acute myeloid leukemia (AML) and myelodysplastic syndrome.
Leschly said, “While the oncology team has been delivering on Abecma, the severe genetic disease team met the moment. We quickly completed an investigation of the SUSAR of AML in our HGB-206 study of LentiGlobin gene therapy for SCD and determined that it was highly unlikely to be due to BB305 lentiviral vector. With these data and the other event changed from an MDS diagnosis to transfusion-dependent anemia, we are now quickly moving to engage with regulators with a goal of lifting the clinical holds in mid-2021.”
In terms of the spinout, earlier in the year, the company announced it was splitting off its oncology business into a separate company. At the same time, it would focus on gene therapies for rare diseases. Now that spinout has an official name, and like bluebird bio, the company has an aversion to capital letters. It is 2seventy bio.
Leschly said, “Two hundred seventy miles per hour is the maximum speed of human thought. The name 2seventy was selected to signify this speed and our team’s translation of thought to action as we advance our next generation pipeline of transformative cell therapies to help cancer patients urgently in need.”
2seventy bio will take over Abecma and other oncology assets. They also announced the leadership team, with Leschly as chief executive officer, Chip Baird as chief financial officer, Philip Gregory as chief scientific officer and Nicola Heffron as chief operating officer.
Bluebird’s bio’s management team will include Andrew Obenshain as chief executive officer, Jason Cole as chief business officer, Rich Colvin as interim chief medical officer and Anne-Virginie Eggiman as senior vice president, regulatory science.
“As we move towards separation, I’m pleased to have key leadership team members in place that are poised to bring bluebird bio to its next phase of success,” said Obenshain. “With the addition of Tom Klima to lead our commercial efforts, we are rounding out our team with experts with a deep level of expertise from early-stage clinical development to commercial delivery. I’m excited about our path forward and look forward to continuing to expand the bluebird team to bring gene therapy to patients with severe genetic diseases.”
On the downside, bluebird bio reported a significant drop in total revenues for the quarter, from $21.9 million in 2020’s first quarter to $12.8 million in this year’s first quarter. The company said it was driven by a drop in license and manufacturing services revenue for ide-cel and a drop in revenue associated with treating patients in a Phase I trial of the gene therapy in multiple myeloma under its deals with BMS.
Research and development costs rose slightly from $143.1 million in the first quarter of 2020 to $154.5 million in this quarter. Selling, general, and administrative expenses also increased from $73.2 million in the first quarter of 2020 to $86.9 million this quarter.
