Aurigene Oncology Reports Positive Phase 1 Results for India’s First CAR-T Therapy in Multiple Myeloma

Aurigene Oncology Limited, a subsidiary of Dr. Reddy’s Laboratories Limited, has published the Phase 1 results for Ribrecabtagene autoleucel (DRL-1801) from the SWASTH study. This represents India’s inaugural trial for a novel autologous BCMA-directed CAR-T cell therapy aimed at treating patients with relapsed or refractory multiple myeloma.

The initial study involved eight patients who had previously undergone extensive treatments, with a median of 5.5 prior lines of therapy. Many of these patients had also experienced disease progression post-transplant. The results were promising, with all eight patients (100%) exhibiting a clinical response. Notably, five out of the eight patients (62.5%) achieved a stringent complete response. In terms of safety, no high-grade events of Cytokine Release Syndrome (CRS) or neurotoxicity were observed in any of the patients.

Upon review of the Phase 1 data, the Drugs Controller General of India (DCGI) has approved the commencement of the Phase 2 part of the trial. The Phase 1 results were recently presented at the 21st annual meeting of the International Myeloma Society in Rio De Janeiro, Brazil. Dr. Murali Ramachandra, CEO of Aurigene Oncology Limited, expressed excitement about the initial results, emphasizing that the drug has the potential to be transformative for Indian myeloma patients.

Ribrecabtagene autoleucel is a specialized autologous anti-BCMA CAR-T therapy. It employs a humanized single-domain antibody as its antigen-binding domain and uses lentivirus as the vector. The DRL-1801 for clinical trials is produced at Aurigene Oncology’s CAR-T GMP manufacturing facility in Bangalore.

Aurigene Oncology Limited, established in 2002, is committed to developing innovative and effective cancer therapeutics. The company has been instrumental in discovering 20 novel chemical entities for clinical development, some in collaboration with global pharmaceutical and biotech companies, and others independently. Aurigene has out-licensed several assets and is currently involved in the clinical development of 10 assets.

The clinical pipeline of Aurigene includes first-in-class oral inhibitors of the immune checkpoint protein CD47, the first-in-class inhibitor of fatty-acid binding protein FABP5, and best-in-class inhibitors of acetyl transferases CBP and p300. Aurigene also has a robust pre-clinical pipeline, featuring advanced programs focused on the selective degradation of SMRACA2, first-in-class CBP, p300, and pan-KRAS degraders.

The approval of Phase 2 trials marks a significant milestone for Aurigene Oncology Limited and the future of cancer treatment in India. With these promising results, the company is poised to make substantial strides in the treatment of multiple myeloma and potentially other cancer types.