A company developing what could become the first CAR-T cell therapy approved for multiple myeloma has sold the milestone and royalty obligations for markets outside the U.S. to its development partner.
In connection with its first quarter 2020 earnings, Cambridge, Massachusetts-based bluebird bio said Monday that it had sold ex-U.S. milestone and royalty obligations to New York-based Bristol-Myers Squibb for $200 million for its lead CAR-T candidate, idecabtagene vicleucel, or ide-cel for short, and a follow-up candidate, bb21217. The two companies have a development partnership that dates back to 2013, when bluebird made a deal with Celgene, which BMS bought last year. Ide-cel is currently under review by the Food and Drug Administration.
BMS and bluebird will continue to share profits and losses on the CAR-Ts in the U.S. market, and bluebird is in the process of building a manufacturing plant for the therapy in Durham, North Carolina. The plant will manufacture lentiviral vectors for ide-cel and the company’s pipeline, while BMS will assume responsibility for the vectors’ manufacture outside the U.S.
Shares of bluebird rise nearly 6.5% on the Nasdaq when markets opened Monday, to $63.11 per share.
“Under our amended collaboration, we and BMS are redoubling our commitment to ide-cel and optimizing the relationship as we work together to bring this critical treatment to patients in the commercial setting,” bluebird chief business officer Joanne Smith-Farrell said in a statement. “With bluebird exiting the passive participation as supplier outside the U.S., we and BMS are taking steps to ensure an efficient and robust supply chain for this program.”
The companies announced topline results from the registration-directed Phase II KarMMa study in early December. Results showed the trial met its primary endpoint of showing improvement in overall response rate, a composite of the percentages of patients who achieved a partial or complete response on ide-cel. The ORR for all three dose levels – 150 million, 300 million and 450 million cells – was 73.4% among 128 patients, which included a complete response and stringent complete response rate of 31.3%. Updated data from KarMMa will be presented in the American Society of Clinical Oncology’s virtual annual meeting.
Ide-cel works by targeting BCMA, an antigen widely expressed on the surface of multiple myeloma cells. Several other therapies are also in development that target BCMA, including BMS’ in-house CAR-T orvacabtagene autoleucel – developed by Juno Therapeutics, which Celgene acquired in 2018 – a competing CAR-T that Johnson & Johnson in-licensed from a Chinese firm and monoclonal antibody-based therapies from Amgen and GlaxoSmithKline.
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