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2seventy, Bristol Myers Squibb Improving Manufacturing Capacity for Abecma

NEW YORK – 2seventy Bio on Monday said it has increased manufacturing capacity for the autologous CAR T-cell therapy Abecma (idecabtagene vicleucel), which it sells with partner Bristol Myers Squibb, and provided an update on its next-generation cell therapy pipeline.

According to 2seventy, it and BMS are delivering the CAR T-cell therapy at an average in-spec rate of 85 percent to 90 percent with an approximately 30-day turnaround time from apheresis to treatment delivery. During its Q3 2022 earnings call, BMS reported strong demand for Abecma but said that manufacturing capacity limitations were weighing down the ability to quickly produce treatments.

2seventy believes Abecma, a BCMA-directed CAR T-cell therapy approved in the US as a fifth-line treatment for relapsed or refractory multiple myeloma patients, has the potential to generate between $2 billion and $3 billion in peak sales. The Cambridge, Massachusetts-based firm said it is expecting 2022 US revenues from the drug, which it splits with BMS, to be between $250 million and $300 million, and it is hoping to hit the upper end of that range. Having increased manufacturing capacity, however, 2seventy projected US revenues of between $470 million and $570 million in 2023 and said it expects the drug to generate between $200 million and $300 million in operating income for the 2024 to 2025 period.

2seventy and BMS are attempting to move Abecma into earlier lines of therapy and, toward that end, last year reported data from the KarMMa-3 and KarMMa-2 trials. The companies will file a supplemental Biologics Licensing Application in Q1 with the US Food and Drug Administration containing KarMMa-3 data on Abecma's activity in multiple myeloma patients who have relapsed or become refractory after two to four lines of therapy and are refractory to the last regimen. Based on data from the KarMMa-2 trial, the companies will launch the KarMMa-9 study this year and evaluate Abecma in newly diagnosed multiple myeloma patients.

Other than Abecma, 2seventy is developing bbT369, a CD79a/CD20-targeting CBLB gene-edited CAR T-cell therapy, in relapsed or refractory B-cell non-Hodgkin lymphoma; SC-DARIC33, a CAR T-cell therapy in patients with acute myeloid leukemia; a CAR T-cell therapy targeting MUC16 in patients with relapsed or refractory ovarian cancer; and a potency enhanced MAGE-A4 TCR program.

The company is continuing to enroll B-NHL patients into an ongoing Phase I study of bbT369, which has completed the first dose-escalation phase and is moving on to the second dose level. There have been no dose-limiting toxicities observed to date in this trial, data from which the company said it would share later this year. A Phase I trial of SC-DARIC33 in AML is underway in collaboration with Seattle Children's Research Institute, and 2seventy is expecting to present initial clinical data this year. 2seventy and collaborator Regeneron plan to file an investigational new drug application for the MUC16-targeted CAR T-cell therapy. Finally, 2seventy is planning to launch an investigator-initiated trial in China with JW Therapeutics for the MAGE-A4 program initially focused on esophageal cancer in 2023.

2seventy entered 2023 with approximately $268 million in cash, cash equivalents, and marketable securities.