FDA granted IND clearance for C-TIL051, CBMG's novel autologous TIL therapy, for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC)
Rockville, MD /PRNewswire/ - Cellular Biomedicine Group Inc. (CBMG or the "Company"), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced that the Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application to proceed with Phase 1 clinical development of its novel Tumor Infiltrating Lymphocyte (TIL) product C-TIL051 for late-stage Non-Small Cell Lung Cancer (NSCLC) patients that are relapsed or refractory to anti-PD1 therapy.
C-TIL051 is an autologous adoptive cell therapy comprised of a patient's ex vivo expanded lymphocytes using CBMG's proprietary manufacturing process.
"This is outstanding news for NSCLC patients who are faced with limited treatment options. C-TIL051 could potentially offer an alternative treatment and our preclinical data show that C-TIL051 might have the potential to be superior. We are working closely with clinical sites and plan to initiate the C-TIL051 Phase 1 trial soon," said Tony (Bizuo) Liu, Chairman and CEO of CBMG. "FDA clearance of the C-TIL051 IND is a significant milestone for CBMG. We plan to start manufacture of clinical batches of C-TIL051 in our GMP facility at Rockville Maryland in the near future."
C-TIL051 is manufactured and released at CBMG's state-of-the-art GMP facility in Rockville Maryland using a proprietary process that can achieve clinical doses more rapidly and more efficiently than traditional TIL manufacturing methods. The process involves ex vivo expansion of tumor infiltrating lymphocytes in a two-step process. C-TIL051 has not been previously studied in human clinical trials however the rationale for developing C-TIL051 was based on initial NSCLC TIL studies demonstrating encouraging safety and efficacy results (NCT03215810, NCT03645928).
Cellular Biomedicine Group Inc. (CBMG) develops proprietary cell therapies for the treatment of cancerous diseases. CBMG operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the United States. CBMG currently conducts ongoing studies in Chimeric antigen receptor (CAR) T-cell therapies, including C-CAR039, an anti-CD19&CD20 bi-specific CAR (BiCAR) Phase 1b trial targeting treatment for non-Hodgkin lymphoma (NHL), and is conducting studies in tumor-infiltrating lymphocytes (TIL) therapies targeting solid tumors.