2seventy bio has sold its cell therapy pipeline and operations to Regeneron Pharmaceuticals for at least $15 million, as part of a restructuring that includes eliminating 14% of its workforce—about 30 jobs—changing its CEO, and limiting its focus to further developing its sole marketed drug.
The approximately 150 employees working within 2seventy’s cell therapy operations will continue their work within a new research and development unit of Regeneron to be called Regeneron Cell Medicines, where they are expected to advance 2seventy’s pipeline of more than a half dozen cell therapies, as well as explore combinations with Regeneron’s antibodies and bispecific candidates. The sale includes 2seventy’s cell therapy discovery and clinical manufacturing capabilities.
The selloff is the culmination of a relationship stretching back to 2018 between Regeneron and Bluebird Bio, which spun out its oncology operations into 2seventy bio in 2021. Regeneron initially invested $100 million in Bluebird under a five-year collaboration designed to develop and commercialize new immune cell therapies for cancer. Last year, Regeneron made a $20 million equity investment in 2seventy bio at a 50% premium, and committed to paying the company another approximately $20 million in near-term preclinical and clinical milestones.
“Our expertise in antibody technologies and emerging genetics capabilities, combined with 2seventy’s cell therapy platforms, presents a significant opportunity to address cancer and other serious diseases in new and impactful ways,” George D. Yancopoulos, MD, PhD, Regeneron’s board co-chair, co-founder, president and chief scientific officer, said in a statement.
Following the selloff to Regeneron, the slimmed-down 2seventy will employ approximately 65 people, primarily in quality and supporting functions—and will refocus its operations on further development of Abecma® (idecabtagene vicleucel or “ide cel”), the B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy it co-markets with Bristol Myers Squibb (BMS).
Abecma won FDA approval in 2021 for its sole indication of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Under the name ide-cel, the drug is in clinical studies for earlier line treatment of multiple myeloma.
Outside of ide-cel, 2seventy’s current pipeline is anchored by two Phase I candidates. One is SC-DARIC33, a drug-regulated chimeric antigen receptor T cell (CAR T) candidate being developed for relapsed/refractory pediatric acute myeloid leukemia, and developed through 2seventy’s DARIC T cell platform. DARIC33 is also in preclinical development for adult acute myeloid leukemia.
The other clinical candidate is bbT369, a CAR T-cell therapy targeting CD79a and CD20 with a gene edit, developed through 2seventy’s megaTAL™ gene editing platform. bbT369 is in the Phase I portion of the Phase I/II CRC-403 trial (NCT05169489), which is assessing the candidate in relapsed and/or refractory B cell non-Hodgkin’s lymphoma (NHL).
Also in 2seventy’s pipeline to be sold to Regeneron are preclinical candidates that include its MUC16-targeted CAR T-cell therapy program in ovarian cancer, being developed in partnership with Regeneron; its MAGE-A4 T cell receptor (TCR) program in autoimmune disease, partnered with JW Therapeutics; and programs aimed at several undisclosed targets.
“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. The Board is confident that the actions announced today will maximize value for shareholders and best position our assets to deliver for patients,” stated Nick Leschly, 2seventy’s top executive or “chief kairos officer.”
Leschly has helmed 2seventy since it was formed in 2021, when Bluebird Bio spun out its oncology business. At the time, that oncology business consisted of 13 programs (seven clinical, six preclinical). Leschly previously served as Bluebird’s CEO or “chief Bluebird” from 2010 until the separation, which left the surviving Bluebird with a new CEO, three candidates and an R&D focus on severe genetic diseases.
Upon completion of the restructuring, Leschly will step down from 2seventy’s helm and become the company’s board chair. Chief operating officer Chip Baird will ascend to CEO, heading a leadership team that will include chief financial officer Vicki Eatwell, currently senior vice president of finance, and Jessica Snow, senior vice president, quality and head of operations.
2seventy said it would incur a one-time cost of approximately $8 million, primarily in the first half of 2024, in connection with the restructuring relating to severance and retention packages and related benefits among employees whose jobs are being eliminated. The company expects make up that expense, projecting savings of approximately $150 million this year and $200 million in 2025.
Extending runway to 2027
The restructuring is expected to extend 2seventy’s cash runway beyond 2027—a year beyond the 2026 timeframe extension envisioned in September 2023 when the company eliminated about 40% of its then-workforce, 176 jobs. That restructuring had been projected to save the company at least $130 million over two years.
Regeneron agreed to pay 2seventy $5 million upfront plus a one-time $10 million milestone payment tied to achieving the first major market approval of the first approved product, as well as royalty payments based on net sales of any pipeline candidates if commercialized.
2seventy highlighted the need to raise capital when it released third quarter 2023 results in November: “The Company’s continued operations are dependent on its ability to raise additional funding and generate operating cash flows from Abecma sales and the commercialization of its product candidates, if approved,” 2seventy stated in its Form 10-Q quarterly report for Q3.
During the firth nine months of 2023, according to the filing, 2seventy reported a net loss of $160.7 million and used $103.3 million of cash in operations. “The Company expects to continue to generate operating losses and negative operating cash flows for the foreseeable future.”
Upon completion of the deal with Regeneron, 2seventy’s board will consist of Leschly and Baird as well as Denice Torres, lead independent director and a former Johnson & Johnson executive; Sarah Glickman, chief financial officer of Criteo; Wei Lin, MD, CMO of Erasca; Dan Lynch, Google Ventures; and Marcela Maus, Mass General Cancer Center. A current member of 2seventy’s board, Dan Lynch will step down in June after 13 years of service on the boards of 2seventy and predecessor Bluebird Bio, and will continue in an advisory role for 2seventy.