HYDERABAD: Dr Reddy’s Laboratories’ wholly-owned subsidiary, Aurigene Oncology Limited, has received Drugs Controller General of India (DCGI) approval for conducting a phase-2 trial for India’s first novel autologous BCMA (B-cell maturation antigen) directed CAR-T (chimeric antigen receptor) cell therapy called Ribrecabtagene autoleucel.
The DCGI nod comes after Aurigene Oncology, a clinical stage biotech, successfully conducted phase-1 trials for Ribrecabtagene autoleucel in patients suffering from relapsed or refractory multiple myeloma and is codenamed DRL-1801.
Ribrecabtagene autoleucel utilises a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. Dr Reddy’s said DRL-1801 for the clinical trials is being manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology Limited in Bengaluru.
The phase-1 trial involved eight patients that were heavily pre-treated with a median of 5.5 previous lines of treatment. Most of these patients had also received transplant in the past and had disease progression post-transplant.
“All eight patients (100%) achieved clinical response, with five out of eight (62.5%) having achieved stringent complete response. With respect to safety, there were no high-grade events of Cytokine Release Syndrome (CRS) or neurotoxicity, in any of the patients,” Dr Reddy’s said in a regulatory filing with the bourses.
The results of the phase-1 study were also presented at the 21st annual meeting of the International Myeloma Society at Rio De Janeiro, Brazil, held recently, the company said.
“The results from the 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 Ltd CEO Dr Murali Ramachandra said.
