MaSTherCell and Iovance Form Mfg. Agreement

Iovance Biotherapeutics has partnered with cell therapy contract development and manufacturing organization (CDMO) MaSTherCell S.A., a subsidiary of Orgenesis Inc. through Masthercell Global Inc. According to the new three-year Manufacturing Services Agreement, MaSTherCell will manufacture TIL for Iovance’s European late-stage clinical trials in its commercial-ready cGMP manufacturing suites.
 
“We are pleased to be expanding our clinical and manufacturing capacity in Europe through this new collaboration with MaSTherCell. We have been dosing patients with lifileucel in Europe for the treatment of metastatic melanoma and LN-145 for the treatment of cervical cancers. As part of our global development plan for our TIL product, we are initiating the IOV-COM-202 trial in Europe as well and have received approval from the Medicines and Healthcare products Regulatory Agency (MHRA). This newly established relationship with MaSTherCell will add additional commercial-ready capacity to support our ongoing and upcoming trials,” said Maria Fardis, president and chief executive officer, Iovance Biotherapeutics. “MaSTherCell specializes in clinical and commercial manufacturing of cell therapy as well as process development which brings valuable expertise and capabilities to our development program. We look forward to working with them to deliver our TIL product to patients with solid tumors across Europe.”
 
Denis Bedoret, general manager, MaSTherCell, said, “We are glad that Iovance called on our expertise to accelerate the development of their TIL products. By addressing the unmet needs for solid tumor treatment, the outcome of this project could represent an enormous hope for a considerable number of patients. MaSTherCell is really pleased to welcome Iovance in its new commercial plant for advanced cell therapy manufacturing.”