Dive Brief:
- CRISPR Therapeutics and MaSTherCell have signed an agreement to develop and manufacture allogeneic CAR-T therapies.
- CRISPR is a leader in gene-based therapeutics and MaSTherCell is a contract development and manufacturing organization (CDMO). Their agreement will help develop the CRISPR’s CAR T-cell therapy, CTX101.
- As well as developing and manufacturing CTX101 for clinical studies, the two companies will collaborate to accelerate research on products in CRISPR’s pipeline.
Dive Insight:
CTX101 is an allogeneic CAR T-cell therapy currently being developed to treat CD19-positive malignancies. MaSTherCell will develop and use cGMP manufacturing to prepare CTX101 for clinical studies. CTX101 is an allogeneic, or off-the-shelf, cell product and addresses the challenges inherent in developing the current generation of autologous therapies, said CRISPR.
MaSTherCell provides manufacturing and process optimization for cell therapy organizations.
CAR-T treatments such as CTX101 are considered complex, personalized treatments, and manufacturing of these products has faced hurdles in the past.
Dendreon’s prostate cancer vaccine, Provenge, for instance, was once thought to be a significant advance for prostate cancer treatment that would help revolutionize the field. However, Dendreon was forced to file for bankruptcy after the biotech ran into trouble financing Provenge’s expensive and complicated manufacturing processes.
Since CAR-T cell therapies are personalized, patient-specific therapies, they can be logistically challenging to manufacture. Manufacturing of products such as CTX101 often requires a complex multi-step process that has stringent quality controls. Before a CAR-T cell product is developed and manufactured, T-cells must be extracted from each patient, and then shipped to a central manufacturing facility.
CRISPR has been one of the leading companies in the CRISPR/Cas9 gene editing space, along with Editas Medicine and Intellia Therapeutics.
MaSTherCell aims to develop optimized process industrialization for cell therapies, and is a subsidiary of Orgenesis. Orgenesis is a cell therapy and regenerative medicine company with the stated goal of developing a cure for Type 1 diabetes.