Cell therapy weekly: CARVYKTI gets FDA approval for second-line treatment of multiple myeloma
This week: Ascend Advanced Therapies (London, UK) acquired GMP manufacturing capacity in Florida, Charles River Laboratories International (MA, USA) and Axovia Therapeutics (London, UK) announced a collaboration to develop and manufacture gene therapies for ciliopathies and The US FDA has expanded the use of CARVYKTI® as an earlier treatment for multiple myeloma.
The news highlights:
- Ascend expands expertise and GMP capabilities
- Collaboration to advance gene therapies for ciliopathies
- CARVYKTI gets US FDA approval for second-line treatment of multiple myeloma
Ascend expands expertise and GMP capabilities
Ascend Advanced Therapies has acquired Beacon Therapeutics’ (FL, USA) Contract, Manufacturing and Controls team and Florida-based GMP manufacturing site. Additionally, the transaction includes a long-term partnership with Beacon, ensuring ongoing production of its products, which include three AAV-based gene therapies for ocular diseases.
Ascend’s CEO, Mike Stellas, explained: “This acquisition allows us to now support customers from research through to commercialization and adds to one of the most experienced gene therapy teams in the market. Every day we are working together to grow the company with a long-term mindset of quality first to appropriately balance quality and yield for the life of each product.”
Collaboration to advance gene therapies for ciliopathies
Charles River Laboratories International and Axovia Therapeutics have announced a contract development manufacturing organization collaboration to support the development of gene therapies for ciliopathies. Axovia will utilize Charles River’s plasmid platform, eXpDNA™, and expertise in plasmid DNA production to expedite the journey to clinical trials.
“We are committed to supporting Axovia in the pursuit of creating treatment options for patients living with ciliopathies. The Charles River team brings decades of expertise in HQ plasmid development, and we look forward to using these capabilities to make a difference for patients,” state Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River.
CARVYKTI gets US FDA approval for second-line treatment of multiple myeloma
Following positive results from the Phase III CARTITUDE-4 study, the US FDA has expanded the approval of CARVYKTI (ciltacabtagene autoleucel; cilta-cel), making it the first and only B-cell maturation antigen-targeted therapy approved as a second-line therapy for patients with relapsed or refractory multiple myeloma. Patients must have received at least one prior line of therapy, including a proteasone inhibitor and an immunomodulatory agent and be refreactory to lenalidomide.
“The expanded label of CARVYKTI has the potential to transform the treatment paradigm for multiple myeloma by providing patients and physicians with a personalized immunotherapy that can be used earlier in the treatment regimen. Multiple myeloma is an incurable and progressive hematologic cancer that causes patients to relapse and become refractory to treatment, so new, innovative options are desperately needed,” said Ying Huang, CEO of Legend Biotech (NJ, USA). “We are committed to improving the lives of patients battling blood cancer and will continue to work towards developing cellular therapies that bring us closer to a cure.”
