Dr. Reddy's Laboratories Ltd. and Shenzhen Pregene Biopharma Co., Ltd. today announced an agreement whereby Dr Reddy's will acquire an exclusive license in the Republic of India for PRG1801, Pregene's single domain antibody-based anti-BCMA chimeric antigen receptor T (CAR-T) cell therapy injection.

Dr. Reddy's acquires the exclusive rights to commercialize PRG1801 in India, and will be responsible for future development including clinical trials, in India. Pregene will be the exclusive supplier of the core material - lentiviral vectors for manufacturing PRG1801. Under the terms of the license agreement, Pregene will receive an upfront payment and future milestone payments of USD 5 million for first indication and up to USD 7.5 million of milestone payments for subsequent indications, and is eligible to receive a double-digit royalty, up to USD 150 million, on future sales of PRG1801 in the licensed territory.  

PRG1801 is an autologous anti-BCMA CAR-T therapy in development for the treatment of relapsed/refractory multiple myeloma, and has already demonstrated strong signs of efficacy and an excellent safety profile in 34 patients in an investigator initiated trial in China. In 2020, PRG1801 was granted NMPA IND clearance, and a Phase I clinical trial of the product candidate is ongoing in China.

This license agreement provides Pregene with a strong, experienced partner in the large Indian market, and expands Dr. Reddy's capacity in the field of immune cell therapy for cancers.

About PRG1801

PRG1801 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. The lentivirus vectors are produced by Pregene using a proprietary serum free suspension production system with gene-therapy-grade quality and a high transduction unit yield. This CAR-T therapy has already demonstrated strong signs of efficacy and an excellent safety profile in 34 patients in an investigator initiated trial in China.

Clinical trials of PRG1801 include:

• Phase I trial to evaluate the safety and tolerance of patients with relapsed/ refractory multiple myeloma after anti-BCMA CAR-T infusion, and to determine the maximum tolerated dose (MTD) and/or recommended dose (RD) of anti-BCMA CAR-T for relapsed/refractory multiple myeloma.

• Investigator initiated trial in China to evaluate the safety and efficacy of PRG1801 (NCT03661554). Among 34 patients treated, 30 (88.2%) patients achieved best objective response and 19 (55.8%) patients achieved complete response. No neurotoxicity was observed among treated patients. Grade 3 CRS occurred in only one patient (2.9%), and all the other patients had lower grade or no CRS.

About Pregene

Shenzhen Pregene Biopharma Co. Ltd is a biotechnology company developing innovative cell and gene therapy products based in Shenzhen, China, with laboratory and manufacturing operations in China. Pregene's management and R&D team have prior experience at institutions and companies including the US FDA, Hormel Institute University of Minnesota and the University of Toronto. PRG1801, the company's lead program for the treatment of multiple myeloma, has obtained NMPA IND clearance as the Class I new drug, and Phase I clinical trials in China are now ongoing. Pregene's product pipeline includes various cell therapy programs under development for the treatment of hematological malignancies, solid tumors and bone defects.

About Dr. Reddy's

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe.