Aurigene Announces Phase 1 Study for India’s Novel Autologous CAR-T Cell Therapy Trial

Aurigene announces phase 1 study for India’s first trial for novel autologous CAR-T cell therapy for multiple myeloma

Overview

Aurigene Oncology Limited, a wholly-owned subsidiary of Dr Reddy’s Laboratories Limited and a clinical stage biotech committed to bringing in novel and effective therapeutics for the treatment of cancer, has announced the phase 1 results for ribrecabtagene autoleucel (DRL-1801) from the SWASTH study – India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed/refractory multiple myeloma.

The Results 

• The study reported initial results from the first 8 patients. All patients were heavily pre-treated with median of 5.5 previous lines of treatment. 
• Most patients had also received transplant in the past and had disease progression post-transplant. 
• All 8 patients achieved clinical response, with 5/8 (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.

Commencing Phase II by DGCI Approval

• After reviewing the phase 1 data, the Indian Regulatory Agency i.e., Drugs Controller General of India (DCGI), has given the nod to commence phase 2 part of the trial. 
• These results of phase 1 were presented at the 21st annual meeting of the International Myeloma Society at Rio De Janeiro, Brazil, held recently.

Words from CEO: Aurigene Oncology

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” commented Dr. Murali Ramachandra, CEO, Aurigene Oncology.

About Ribrecabtagene Autoleucel

• • Ribrecabtagene autoleucel is an autologous anti-BCMA CAR-T therapy that utilizes a humanized single-domain antibody as the antigen binding domain and lentivirus as a vector. 
• • DRL-1801 for the clinical trials is manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology in Bangaluru.

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