NEW YORK – 2seventy Bio on Tuesday said it will restructure its business and reduce its workforce by about 40 percent.
As part of the corporate restructuring, the Cambridge, Massachusetts-based firm said it is cutting 176 staff positions, which will save $130 million during 2024 and 2025, with additional savings possible if 2seventy further reduces expenses related to facilities and other costs. It will also pause research on several early-stage targeted therapeutic programs and new technologies, while transferring two programs — one in solid tumors and one in autoimmunity — into an expanded partnership with Shanghai-based JW Therapeutics.
The one-time restructuring will cost the company $9 million, which will be primarily incurred in Q3. 2seventy expects these changes to extend its cash runway into at least 2026.
Going forward, 2seventy will focus on increasing use of Abecma (idecabtagene vicleucel), the CAR T-cell therapy it markets with Bristol Myers Squibb as a fifth-line treatment for relapsed or refractory multiple myeloma. 2seventy had projected 2023 revenues for Abecma in the range of $470 million to $570 million, but the company is now expecting Q3 sales to decline and is anticipating lower-than-expected full-year revenues.
BMS reported $147 million in Q1 2023 revenues for the product, more than double the $67 million the drug recorded in Q1 2022. However, revenue growth began to level off in Q2 when BMS had to shut down one of its manufacturing facilities for planned maintenance and prepare for the drug's anticipated approval as a third-line multiple myeloma treatment this coming December based on results from the Phase III KarMMA-3 trial. That label expansion could increase the addressable market for Abecma from 4,000 patients currently to 16,000 patients in 2024, 2seventy CFO Chip Baird said in a conference call on Tuesday.
Nick Leschly, who announced he will transition from CEO to chair of 2seventy's board of directors upon identification of a successor, acknowledged on the call that Abecma has faced challenges this year, including competition from new T-cell engager therapies and Janssen's multiple myeloma CAR T-cell drug Carvykti (ciltacabtagene autoleucel), as well as a "misinterpretation" in the market about Abecma's potential during the manufacturing downtime. Leschly gave Janssen credit for quickly increasing its Carvykti supplies, but he still felt the market has "exaggerated" the advantage Carvykti has over Abecma.
Within 2seventy's leaner portfolio, it is continuing a MAGE-A4 T-cell receptor therapy program with JW Therapeutics and is still developing a MUC16-targeted CAR T-cell therapy in ovarian cancer with Regeneron. 2seventy Chief Medical Officer Steven Bernstein said on the call that by year-end, the MUC16 program is on track for an investigational new drug application submission and for an investigator-initiated study of the MAGE-A4 candidate to begin in China.
2seventy will also continue a Phase I trial of bbT369, an autologous CAR T-cell therapy under development in B-cell non-Hodgkin lymphoma, after seeing encouraging safety and clinical data, including complete responses in some patients. However, 2seventy will decide whether to advance bbT369 beyond Phase I after seeing the final efficacy results.
The company is also working with the US Food and Drug Administration to restart a Phase I trial of another autologous T-cell therapy, SC-DARIC33, in patients with CD33-positive acute myeloid leukemia. The FDA placed a clinical hold on that program after a patient in that study had a grade 5 serious adverse event.