Meet the Little-Known Chinese CAR-T Biotech Up More Than 500% Since June 2017
CAR-T therapies have been driving headlines for months since the U.S. Food and Drug Administration approved the first two gene-therapy treatments last year. While CAR-Ts have given new hope in the west for the treatment of blood cancers, in China the hope has yet to be realized.
But one company, GenScript Biotech Corp. is looking to break out and become the first company in China to move a CAR-T product into human trials. Its drive to be the first has pleased investors. According to a Bloomberg analysis, shares of GenScript, which is sold on the Hong Kong Stock Exchange, have risen more than 500 percent since June. What sparked that spike were positive results from early studies in 35 patients with a type of blood cancer, Bloomberg said. During the American Society of Clinical Oncology meeting in June 2017, GenScript, a gene synthesis specialist reported 33 of 35 patients with relapsed or treatment-resistant multiple myeloma experienced remission within two months of receiving the company’s CAR-T treatment, Bloomberg reported.
It’s likely the stock could continue to rise when it begins human testing. GenScript could initiate human trials in China by the second quarter, Bloomberg said. If all goes well, the company believes that it could be ready for commercialization by the end of 2020. Shares of GenScript Bio were up more than 3 percent today, trading at 22 KHD.
Laura Nelson Carney, an analyst at Sanford C. Bernstein told Bloomberg that GenScript is working in well-trod areas of CAR-T – the same areas that Novartis AG and Gilead Sciences (which acquired Kite Pharma) have explored with their approved CAR-T treatments.
“They are not working on anything that no one else in the world is working on,” Nelson Carney told Bloomberg. “They don’t have anything that’s totally new and unique.”
In December, the China Food and Drug Administration accepted GenScript’s application to begin human testing for LCAR-B38M for multiple myeloma. It also placed the study under priority review, Bloomberg reported.
At the same time, the Chinese FDA greenlit its CAR-T trials. Legend Biotech also forged an alliance with Janssen Pharmaceuticals. In December, the two companies struck a development deal for CAR-T drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen (BCMA), a protein that is highly expressed on myeloma cells. The companies have entered into a 50/50 percent cost-sharing/profit-split arrangement, except in Greater China, where Janssen and Legend have a 30/70 percent cost-sharing/profit-split arrangement, according to terms of the deal.
GenScript is not the only CAR-T game in China. Bloomberg said there are currently 153 ongoing CAR-T studies in China, which is second only to the 186 ongoing studies in the United States. Other companies developing CAR-T treatments in China include Cellular Biomedicine Group and Galaxy Biomedical Investment Co.