2seventy Bio has traveled a difficult path ever since it spun out from bluebird bio to work on cancer cell therapies. Now, the company is splitting in two once again, passing its R&D programs to Regeneron and going all-in on its Bristol Myers Squibb-partnered CAR-T, Abecma.
As Abecma's 2023 sales are expected to fall below 2seventy's original guidance of $470 million, the biotech on Tuesday outlined several steps it plans to take to return the BCMA CAR-T to commercial growth in 2024.
The plan hinges on a planned label expansion, manufacturing upgrades, doctor education and more, 2seventy said in a press release.
After Abecma's FDA approval in April 2021, sales of the drug jumped out to $388 million in 2022. More recently though, BMS has reported a slowdown thanks to the competitive multiple myeloma landscape.
In the third quarter of 2023, Bristol reported $93 million in global Abecma sales, a 13% decline from the prior quarter. During a conference call, Bristol's CEO Chris Boerner said that "in-class competition" and new bispecific rivals "have impacted performance."
"At the same time, real-world data generated by a consortium of KOLs demonstrates that our efficacy, safety, and reliability are quite competitive," Boerner said at the time.
"Our focus will be on ensuring our teams are fully leveraging this breadth of data to effectively reinforce the profile of this important treatment," the BMS CEO continued.
As for 2seventy, the biotech partner said it’s looking forward to an FDA decision on Abecma based on the cell therapy’s KarMMA-3 clinical study, which could push the medication into the larger third-line treatment setting. The drug is currently approved as a fifth-line therapy.
What’s more, 2seventy and BMS are expanding their Abecma treatment site footprint to help more patients access the treatment, 2seventy said. Part of that push will include renewed physician education—especially on treatment sequencing and the emerging data supporting the use of BCMA-directed CAR-Ts before other BCMA-targeted therapies. Further, 2seventy wants to help doctors recognize the significance of Abecma’s real-world safety and efficacy.
The last portion of 2seventy’s plan revolves around manufacturing. Specifically, 2seventy says it will continue to support the quality control of the lentiviral vector (LVV) manufacturing for Abecma, as well as support the transition to suspension LVV, which has the potential to deliver additional efficiencies and savings.
These aren’t exactly new strategies for the struggling biotech. Back in mid-November, during 2seventy’s third-quarter earnings report, the company stressed that in order to restore Abecma growth, it would focus on rapidly expanding the treating site footprint, competitively differentiating Abecma’s real-world safety and data profile and pushing for more doctor education on the use of CAR-Ts before T cell engagers and antibody-drug conjugates.
As for 2seventy’s split and handover of its clinical programs to Regeneron, the full financial details of the transaction were not disclosed, but 2seventy will receive $5 million upfront, plus a milestone payment from Regeneron for the first market approval from the transaction.
Regeneron is set to take over development and commercialization rights on the biotech’s pipeline of immune cell therapies, plus discovery and clinical manufacturing capabilities. Further, some 150 employees from 2seventy are set to join Regeneron in a newly formed unit called Regeneron Cell Medicines, which will focus on oncology and immunology.
2seventy itself formed from the spinoff of bluebird bio's cancer business into a new company. Now with the R&D sale to Regeneron, the resulting company's focus is even smaller.
2seventy’s renewed Abecma push comes as the med’s CAR-T rival—Johnson & Johnson and Legend Biotech's Carvykti—is gaining momentum thanks to its perceived better clinical data.