Cell therapy weekly: Priority review for encapsulated cell therapy
This week: Neurotech Pharmaceuticals (RI, USA) receives priority review of its Biologics License Application for an encapsulated cell therapy to treat Macular Telangiectasia, Charles River Laboratories International (MA, USA) and Captain T Cell (Berlin, Germany) collaborate to manufacture plasmid DNA and retrovirus vectors and C3i Center (Québec, Canada) becomes the first contract development and manufacturing organization (CDMO) in Canada to receive approval to commercially produce cell therapies.
The news highlights:
- Priority review for encapsulated cell therapy
- Partnership for plasmid DNA and viral vector manufacturing
- First Canadian CDMO receives regulatory approval to manufacture cell therapies
Priority review for encapsulated cell therapy
The US FDA has granted priority review of Neurotech Pharmaceuticals’ Biologics License Application for NT-501, an investigational encapsulated cell therapy designed to treat a progressive, neurodegenerative disease of the retina called Macular Telangiectasia. NTC-501 is an ocular implant that continuously delivers therapeutic doses of ciliary neurotrophic factor to the retina to slow disease progression. The implant is made of a semi-permeable capsule containing allogeneic retinal pigment epithelium cells that have been genetically engineered to produce ciliary neurotrophic factor.
“This is a significant achievement for Neurotech,” said CEO, Richard Small. “I would like to express my gratitude to our employees for reaching this important milestone.”
Partnership for plasmid DNA and viral vector manufacturing
Charles River Laboratories International and Captain T Cell, a spinoff from the Max Delbrück Center (Berlin, Germany), have announced a collaboration to produce plasmid DNA and retrovirus vectors. Under Charles River’s Cell and Gene Therapy Accelerator Program, Captain T Cell will gain access to Charles River’s established CDMO expertise and advisory services. This partnership will support Captain T Cell’s preparation to manufacture a TCR-T cell therapy for solid tumor patients in an upcoming Phase I clinical trial.
“We are thrilled to work with the Captain T Cell team to support the manufacture of its TCR-T cell cancer immunotherapy. Charles River has decades of success reliably manufacturing plasmid DNA, viral vectors, and cell therapies, helping to safeguard our customer programs and bring potential therapies to patients with limited options.” stated Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River.
First Canadian CDMO receives regulatory approval to manufacture cell therapies
C3i Center has become the first CDMO in Canada to gain regulatory approval to produce cell therapies after securing a Drug Establishment License. This milestone was reached following an inspection by Health Canada’s cell and gene therapy specialists.
“The C3i team worked hard to meet the requirements of a [Drug Establishment License] and are proud that we received approval from Health Canada to commercially manufacture cell therapies.” said C3i CEO, Louisa Petropoulos. “We are excited to be the first CDMO in Canada to reach this milestone, and there is more to come. Our goal is to manufacture cell and gene therapies for the global market. We expect to have the European Medicines Agency (EMA) conduct their inspection later this fall.”
