HYDERABAD: Dr Reddy’s Laboratories’ wholly-owned subsidiary, Aurigene Oncology Limited, has obtained 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 referred to as Ribrecabtagene autoleucel.
The DCGI nod comes after Aurigene Oncology, a scientific stage biotech, efficiently carried out phase-1 trials for Ribrecabtagene autoleucel in sufferers affected by relapsed or refractory a number of myeloma and is codenamed DRL-1801.
Ribrecabtagene autoleucel utilises a humanized single-domain antibody because the antigen binding area and lentivirus as a vector. Dr Reddy’s stated DRL-1801 for the scientific trials is being manufactured on the CAR-T GMP manufacturing facility at Aurigene Oncology Limited in Bengaluru.
The phase-1 trial concerned eight sufferers that had been closely pre-treated with a median of 5.5 earlier traces of remedy. Most of these sufferers had additionally obtained transplant previously and had illness development 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 stated in a regulatory submitting with the bourses.
The outcomes of the phase-1 research had been additionally introduced on the 21st annual assembly of the International Myeloma Society at Rio De Janeiro, Brazil, held not too long ago, the corporate stated.
“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 stated.
