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With the formation of the new R&D unit, Regeneron will assume full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage cell therapy pipeline.
On Jan. 30, 2024, Regeneron Pharmaceuticals (Regeneron) announced the formation of a new R&D unit, Regeneron Cell Medicines, founded on an agreement with 2seventy bio, a US-based immuno-oncology cell therapy company. Under the agreement, Regeneron acquires full development and commercialization rights to 2seventy bio’s pipeline of investigational novel immune cell therapies, in addition to that company’s discovery and clinical manufacturing capabilities.
The financial terms include an upfront payment of $5 million. Regeneron will also pay a single milestone payment to 2seventy bio for the first major market approval of the first approved product. In addition, Regeneron will pay 2seventy bio a low single-digit percent royalty on revenues generated by the products. The transaction is expected to close in the first half of 2024, pending certain closing conditions.
2seventy bio was spun out from bluebird bio in 2021. Prior to the spinout, Regeneron and bluebird bio entered into an agreement in 2018 to leverage their complementary technologies. The aim was to discover novel cell therapy approaches to address cancer. Under that original agreement, Regeneron had the right to opt-in to a co-development/co-commercialization arrangement for collaboration targets. Now, under the new agreement, Regeneron will acquire full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage pipeline. Regeneron will also assume ongoing program, infrastructure, and personnel costs related to these programs.
Approximately 150 employees will transition from 2seventy bio to Regeneron to continue work on cell therapy programs. These employees will remain in the company’s Cambridge, Mass., and Seattle, Wa., sites. 2seventy bio’s current chief scientific officer, Philip Gregory, will be appointed senior vice-president and head of Regeneron Cell Medicines upon the close of transaction.
The divestment frees up 2seventy bio to focus exclusively on the commercialization and development of Abecma (idecabtagene vicleucel), its B cell maturation antigen (BCMA)-targeted chimeric antigen T-cell (CAR-T) therapy for treating multiple myeloma.
“Together with the [b]oard, we have completed a thorough assessment of our business and strategic options. Based on this process, 2seventy has decided to focus our mission on the growth and success of Abecma,” said Nick Leschly, outgoing chief kairos officer and incoming 2seventy bio board chair, in a Jan. 30, 2024 company press release. “As part of this decision, we will divest our research and development programs, with the majority of our … R&D team transitioning to Regeneron. While the decision to reshape 2seventy was driven by a series of challenging realities, it has resulted in an outcome that we believe is right for patients, employees, and our shareholders.”
“Moving forward, 2seventy will be sharply focused on Abecma, with a streamlined team and a dramatically different cost structure and financial profile,” said Chip Baird, incoming chief executive officer, 2seventy bio, in the press release. “We believe this approach will give 2seventy the financial runway to continue to work closely with our partners at BMS [Bristol Myers Squibb] to support a potential third-line launch of Abecma later this year and a return to growth for the commercial business.”
According to the press release, 2seventy bio’s go-forward organization will include approximately 65 employees, primarily in quality and supporting functions. Through its partnership with Bristol Myers Squibb, 2seventy bio intends to return Abecma to commercial growth in 2024. The company expects a final Prescription Drug User Fee Act action following a planned Oncologic Drugs Advisory Committee meeting on the supplemental biologics license application (sBLA) for Abecma based on a Phase III clinical study (KarMMA-3). If the sBLA is approved, it would expand the therapy’s label into the larger third line setting of treatment.