Cell therapy weekly: US$286 million acquisition expands CAR-T manufacturing and commercialization
This week: Bristol Myers Squibb (NY, USA) will acquire 2seventy bio (MA, USA) for US$286 million under a definitive merger agreement, while RoslinCT (Edinburgh, Scotland) and Ayrmid Pharma (London, UK) plan to collaborate on the commercial production of Omisirge®, an FDA-approved cell therapy. Plus, AskBio (NC, USA) has advanced its Phase I/II trial for AB-1003, a gene therapy for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), by dosing the first patient in its second cohort.
The news highlights:
- US$286M acquisition expands CAR-T manufacturing and commercialization
- Partnership advances production of cell therapy for hematologic malignancies
- Limb-girdle muscular dystrophy gene therapy trial moves forward
US$286 million acquisition furthers manufacturing and commercialization of CAR-T cell therapy
Bristol Myers Squibb will acquire 2seventy bio for US$286 million under a definitive merger agreement and will attain sole responsibility for manufacturing and commercializing Abecma® outside the US.
Abecma, a BCMA-targeting CAR-T cell therapy, is approved for adults with relapsed or refractory multiple myeloma after at least two prior treatments, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
The acquisition follows over a decade of collaboration between the two companies in developing CAR-T therapies. Previously, Abecma was jointly developed and commercialized in the US under a co-development, co-promotion and profit-sharing agreement. The companies’ clinical development program for Abecma includes ongoing KarMMa-2 and KarMMa-3 studies, evaluating its use in earlier lines of treatment for multiple myeloma.
“We believe that Abecma will continue to benefit from [Bristol Myer Squibbs’] experience and resources to ensure this important therapy is delivered to patients who need it,” reflected 2seventy bio’s CEO, Chip Baird. “I would like to express my deep gratitude for current and past 2seventy team members and more broadly the dedicated community of patients, scientists, providers and partners that helped take cell and gene therapy from a complicated idea to reality for patients.”
Partnership towards production of hematologic malignancies cell therapy
Cell and gene therapy CDMO RoslinCT and Ayrmid Pharma plan to collaborate on the production of Omisirge, an FDA-approved modified allogeneic hematopoietic progenitor cell therapy for hematological malignancies, developed by Ayrmid’s subsidiary, Gamida Cell (FL, USA).
RosilnCT and Ayrmid intend to conduct the technology transfer and commercial manufacturing at RoslinCT’s GMP facility in Hopkinton (MA, USA).
“This key strategic move will allow Gamida Cell to source Omisirge for our patients from both our internal manufacturing capability and RoslinCT,” commented Joe Wiley, CEO of Ayrmid.
Limb-girdle muscular dystrophy gene therapy trial progress
AskBio has dosed the first patient in the second cohort of its Phase I/II LION-CS101 trial for AB-1003, a gene therapy for LGMD2I/R9. This follows a Data Safety Monitoring Board review of trial recruitment and safety data from the first cohort.
Launched in 2023, the trial will enroll up to 14 participants across six US sites, with the first-cohort participants remaining in the study until completion.
“The burden of LGMD2I/R9 on patients and their families is profound,” said Nicholas Johnson, Principal Investigator and Vice Chair of Research at the Department of Neurology, Virginia Commonwealth University School of Medicine (VA, USA). “Dosing the first participant in the second cohort of the trial is positive news for people living with LGMD2I/R9. This is a rare and debilitating type of muscular dystrophy, and this advancement brings the LION-CS101 trial another step closer to completion.”
