Dr. Reddy's Laboratories has signed an agreement with Shenzhen Pregene Biopharma to acquire an exclusive license in India for PRG1801, Pregene's single domain antibody-based anti-BCMA chimeric antigen receptor T (CAR-T) cell therapy injection.
Besides acquiring the exclusive rights to commercialise PRG1801 in India, Dr. Reddy’s will be responsible for future development including clinical trials, in the country.
Pregene will be the sole supplier of the core material – lentiviral vectors for manufacturing PRG1801.
As per the terms of the license agreement, Pregene will get an upfront payment and future milestone payments of $5m for first indication and up to $7.5m of milestone payments for subsequent indications.
Pregene is eligible to secure a double-digit royalty, up to $150m on future sales of PRG1801 in the licensed territory.
PRG1801 is an autologous anti-BCMA CAR-T therapy in development intended to treat relapsed/refractory multiple myeloma.
It has demonstrated signs of efficacy and a safety profile in 34 patients in an investigator-initiated trial in China.
Last year, PRG1801 had secured NMPA IND clearance, and a Phase I clinical trial of the product candidate is ongoing in China.
This license agreement offers Pregene with an experienced partner in India, and bolsters Dr. Reddy’s capacity in immune cell therapy for cancers.