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Please find enclosed a Press Release on "Aurigene
Oncology Limited announces promising results of Phase 1 study for India's first trial for novel autologous CAR-T cell therapy for
This is for your information and record.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer & Head-CSR
Limited announces promising results of Phase 1 study for India's first trial for novel autologous CAR-T cell therapy for multiple
Bengaluru & Hyderabad, India; October 8, 2024:
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 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 (100%) 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.
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.
"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 Limited.
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 Limited, Bangalore.
About Aurigene Oncology Limited:
Aurigene Oncology Limited, a wholly owned subsidiary
of Dr. Reddy's Laboratories, is a clinical stage biotech committed to bringing in novel and effective therapeutics for the treatment
of cancer. Founded in 2002, Aurigene has contributed to the discovery of 20 novel chemical entities for clinical development. Some of
these molecules were in collaboration with global Pharma and biotech companies while remaining were developed on its own. Aurigene has
out-licensed several assets and is now engaged in clinical development of 10 assets. Aurigene's clinical pipeline includes first-
in-class oral inhibitor of immune checkpoint protein CD47, first-in-class inhibitor fatty-acid binding protein FABP5 and best-in-class
inhibitor of acetyl transferases CBP and p300. Aurigene also has a strong pre-clinical pipeline, including advanced programs based on
selective degradation of SMRACA2, first-in class CBP, p300 and pan-KRAS degraders.