The CAR-T therapy, PRG1801, is in development as a treatment for relapsed or refractory multiple myeloma. D. Reddy’s said the candidate has shown “strong signs of efficacy and an excellent safety profile” in an investigator-initiated clinical trial in China.
Based on the early promise shown by PRG1801, Dr Reddy’s has agreed to an upfront payment and future milestone payments of US$5m (€4m) for the first indication and up to US$7.5m in milestones for subsequent indications. If PRG1801 comes to market in India, Pregene could receive up to US$150m in double-digit royalties.
The sums involved are small compared to global agreements for other anti-BCMA CAR-T therapies. Notably, Johnson & Johnson paid Legend Biotech US$350m upfront for an even split of the profits generated by anti-BCMA CAR-T therapy LCAR-B38M outside of China, plus 30% of the profits inside China.
Dr Reddy's deal covers a much smaller geographic area, India, that is yet to emerge as a commercial market for cell therapies. Equipped with PRG1801, Dr Reddy’s wants to be the company that brings CAR-T to India.
“Our objective in this is to make cell therapies available to Indian patients at affordable prices. There is no market today. We have to go overseas to get this done,” said GV Prasad, managing director, Dr Reddy’s, on a quarterly results conference call with investors on May 14.
Controlling the cost of manufacturing autologous CAR-T therapies such as PRG1801 is a challenge.
Production entails taking cells from a patient, processing them, and re-administering them back into the same individual, resulting in an expensive, logistically challenging manufacturing workflow.
Dr Reddy’s plans to establish a facility “which will take the cells, convert them into CAR-Ts and then administer them to patients,” said Prasad. Getting PRG1801 to the Indian market and establishing the capabilities needed to make and administer it will require investment, but Dr Reddy’s is downplaying the sales potential of the cell therapy.
“It's not going to be a big product. It's a niche therapy, but it is an area we want to explore because we have a strong presence in oncology, in small molecules as well as biologics,” said Prasad.
By using PRG1801 to explore the CAR-T space, Dr Reddy’s hopes to pick up cell therapy skills that it could apply to other products in the future while delivering an affordable treatment to Indian cancer patients.