Indian firm Dr. Reddy's Laboratories and Shenzhen Pregene Biopharma, based in China, have 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 $5 million for first indication and up to $7.5 million of milestone payments for subsequent indications, and is eligible to receive a double-digit royalty, up to $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.