– Biologics Licensing Application (BLA) submission planned for late 2020 –
SAN CARLOS, Calif., Jan. 15, 2020 (GLOBE NEWSWIRE) — Iovance Biotherapeutics, Inc. (IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that the company has completed dosing the last patient in the registration-enabling Cohort 4 of the C-144-01 study of lifileucel in the treatment of patients with advanced melanoma. Cohort 4 has the primary endpoint of objective response rate (ORR) to be read out by an Independent Review Committee.
“We are quite pleased to complete patient dosing of this pivotal cohort in our study of lifileucel ahead of schedule due to increased demand, bringing this potential therapy one step closer to patients,” said Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive Officer. “We remain on track to submit a Biologics License Application (BLA) subsequent to discussions with FDA, for regulatory approval of lifileucel in late 2020. Lifileucel could be the first approved cell therapy product for solid tumors.”
Iovance Tumor Infiltrating Lymphocytes (TIL) for melanoma, lifileucel, is an investigational, patient-derived cell therapy that involves a 22-day manufacturing process at a centralized facility. Cohort 4 in the C-144-01 study includes post-PD-1 patients with Stage IIIC/IV unresectable melanoma who also have received BRAF/MEK therapy if clinically indicated. Lifileucel has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track and Orphan Drug designations in advanced melanoma.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient’s own immune cells to attack cancer. TIL cells are extracted from a patient’s own tumor tissue, expanded through a proprietary process, and infused back into the patient. After infusion, TIL reach tumor tissue, where they attack tumor cells. The company has completed dosing in the pivotal study in patients with metastatic melanoma and is currently conducting a pivotal study in patients with advanced cervical cancer. In addition, the company’s TIL therapy is being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. A clinical study to investigate Iovance T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is open to enrollment. For more information, please visit www.iovance.com.