Dr. Reddy’s arm Aurigene Oncology gets DCGI nod for Phase 2 trial for CAR-T cell therapy for multiple myeloma 

Dr. Reddy’s Laboratories subsidiary Aurigene Oncology has received the Drugs Controller General of India’s (DCGI) nod to commence Phase 2 trial for Ribrecabtagene autoleucel (DRL-1801), its novel autologous CAR-T cell therapy for multiple myeloma.

The approval comes on the back of Phase 1 results for DRL-1801, which the clinical stage biotech firm said, was India’s first trial for a novel autologous B cell maturation antigen (BCMA) directed Chimeric antigen receptor T (CAR-T) cell therapy in patients with relapsed / refractory multiple myeloma.

After reviewing Phase 1 data, DCGI has given nod to commence Phase 2 part of the trial. The results of Phase 1 were presented at the 21st annual meeting of the International Myeloma Society at Rio De Janeiro, Brazil, held recently, Aurigene Oncology said in a release on Tuesday. DRL-1801 for the clinical trials is manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology, Bengaluru.

“The results from the [Phase I] trial in heavily pre-treated relapsed refractory myeloma patients are very exciting for us in India. We are thrilled with the data, as the drug could be transformative for Indian patients with myeloma,” Aurigene Oncology CEO Murali Ramachandra said.

Published - October 08, 2024 11:38 pm IST