CRISPR Therapeutics AG, a leader in gene-editing based therapeutics, and MaSTherCell SA, a full service contract development and manufacturing organisation (CDMO) and wholly owned subsidiary of Orgenesis Inc., have announced the signing of an agreement to develop and manufacture allogeneic CAR-T therapies.

MaSTherCell will be responsible for the development and cGMP manufacturing of CTX101 for use in clinical studies.

CTX101 is an allogeneic CAR T-cell therapy currently in development by CRISPR Therapeutics for the treatment of CD19 positive malignancies.

The programme utilises CRIPSR’s proprietary gene-editing technology to make targeted modifications to the T-cell, thereby enabling an allogeneic, or off-the-shelf, product that is applicable to a broader patient population and addresses the industrialization challenges of the current generation of autologous therapies.

“The signing of this agreement represents an important milestone for CRISPR Therapeutics as it not only demonstrates our progress with CTX101, but also lays the foundation for our broader activities and emerging pipeline in the allogeneic cell therapy field,” said Jon Terrett, Head of Immuno-Oncology Research and Translation at CRISPR Therapeutics.

“We’re really excited to have initiated work with MaSTherCell. Their market-leading capabilities and deeply relevant experience stood out as we looked for a partner to help accelerate our preclinical programmes towards the clinic in both the US and Europe,” added Samarth Kulkarni, President and Chief Business Officer at CRISPR Therapeutics.

MaSTherCell provides process optimisation and manufacturing services to cell therapy organisations. It has quickly built the most extensive experience in the field and is focused on developing solutions to the industrialisation challenges facing the cell therapy sector.

“We are looking forward to working with CRISPR Therapeutics. They have made significant progress to date with multiplexed gene editing and this provides a solid platform upon which we can bring to bear MaSTherCell’s significant experience in the manufacturing of allogeneic cell therapies,” said Denis Bedoret, General Manager at MaSTherCell.