Aurigene Oncology Limited Announces Promising Results of Phase 1 Study for India’s First Trial for Novel Autologous CAR-T Cell Therapy for Multiple Myeloma

Rhea-AI Summary

Aurigene Oncology , a subsidiary of Dr. Reddy's Laboratories, has announced promising 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:

• 100% clinical response in 8 heavily pre-treated patients
• 62.5% achieved stringent complete response
• No high-grade events of Cytokine Release Syndrome or neurotoxicity

The Indian Regulatory Agency (DCGI) has approved the commencement of the Phase 2 trial. These results were presented at the 21st annual meeting of the International Myeloma Society in Brazil. Ribrecabtagene autoleucel is manufactured at Aurigene Oncology's CAR-T GMP facility in Bangalore.

Positive

• 100% clinical response rate in Phase 1 trial for multiple myeloma treatment
• 62.5% of patients achieved stringent complete response
• No high-grade adverse events reported in the trial
• Approval from DCGI to commence Phase 2 trial
• Potential for transformative treatment for Indian myeloma patients

Negative

• None.

Insights

Medical Research Analyst

The Phase 1 results for Ribrecabtagene autoleucel (DRL-1801) in relapsed/refractory multiple myeloma patients are highly encouraging. The 100% clinical response rate and 62.5% stringent complete response rate in heavily pre-treated patients are impressive outcomes. Notably, the absence of high-grade Cytokine Release Syndrome or neurotoxicity events is a significant safety advantage over some existing CAR-T therapies.

The approval to proceed to Phase 2 by the DCGI indicates regulatory confidence in the therapy's potential. As India's first autologous BCMA-directed CAR-T cell therapy, this represents a major advancement in domestic cancer treatment capabilities. The ability to manufacture the therapy locally at Aurigene Oncology's facility in Bangalore could potentially lead to improved accessibility and reduced costs for Indian patients.

While these early results are promising, investors should note that larger studies are needed to confirm efficacy and safety. The potential market impact could be substantial if the therapy maintains its performance in later-stage trials, potentially positioning Dr. Reddy's as a key player in the growing CAR-T therapy market.

Financial Analyst

This development could have significant positive implications for Dr. Reddy's Laboratories (RDY) and its subsidiary Aurigene Oncology. The CAR-T therapy market is projected to grow rapidly, with some estimates suggesting a 30% CAGR over the next decade. If Ribrecabtagene autoleucel continues to show strong results and gains approval, it could become a major revenue driver for RDY.

The local manufacturing capability is a strategic advantage, potentially leading to higher profit margins and better market penetration in India and possibly other emerging markets. This could differentiate RDY from global competitors who may face higher costs and logistical challenges in these regions.

Investors should monitor the progress of Phase 2 trials closely, as positive results could significantly impact RDY's stock price. However, it's important to note that the CAR-T market is becoming increasingly competitive and the therapy's success will depend on its efficacy, safety and cost-effectiveness compared to other treatments. The $12.9 billion market cap of RDY suggests that success in this area could move the needle for the company's valuation.

BENGALURU, India & HYDERABAD, India--(BUSINESS WIRE)-- 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 (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY), 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241008755325/en/

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Aurigene Oncology Limited

FAQ

What are the Phase 1 results of Aurigene Oncology's CAR-T cell therapy for multiple myeloma (RDY)?

The Phase 1 results showed 100% clinical response in 8 heavily pre-treated patients, with 62.5% achieving stringent complete response. No high-grade events of Cytokine Release Syndrome or neurotoxicity were reported.

Has Aurigene Oncology's CAR-T therapy (RDY) received approval for Phase 2 trials?

Yes, after reviewing the Phase 1 data, the Drugs Controller General of India (DCGI) has approved the commencement of the Phase 2 trial for Ribrecabtagene autoleucel (DRL-1801).

Where is Aurigene Oncology's CAR-T therapy (RDY) manufactured?

Ribrecabtagene autoleucel (DRL-1801) for clinical trials is manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology in Bangalore, India.

What type of cancer does Aurigene Oncology's CAR-T therapy (RDY) target?

Aurigene Oncology's CAR-T therapy targets relapsed/refractory multiple myeloma, a type of blood cancer affecting plasma cells.