Legend Biotech has calculated one of its early-stage CAR-T treatments isn’t ready for showtime, scrapping phase 1 plans for a cell therapy that just six weeks ago was freed from a FDA hold.
The decision by Legend to ax LB1901, an autologous chimeric antigen receptor (CAR) T cell therapy to treat relapsed or refractory T-cell lymphoma, boiled down to two factors, according to a SEC filing. First, the company reports that a “similar Legend Biotech CAR-T product candidate” failed to show a clinical benefit in a trial in China. A company spokesperson did not respond to questions about the clinical data of this similar product by the time of publishing.
Additionally, Legend wants to spend money elsewhere in its pipeline. As a result, the company has canceled its phase 1 study for the drug.
The decision comes just six weeks after LB1901 was freed from a FDA clinical hold. The company had first voluntarily paused the trial after one patient reported low CD4+ T-cell counts, which was swiftly followed by an official hold placed on February 11. That was eventually lifted more than three months later on May 25, news the company snuck into its first quarter earnings report.
The CAR-T at play targets malignant CD4+ T cells and only one patient had been dosed in the trial at the time of the hold. It’s one of a number of cell therapies that Legend hopes can blossom into a follow-up to Carvykti, the company’s FDA-approved treatment for multiple myeloma in partnership with Johnson & Johnson.But Legend lacks a med in its pipeline outside of Carvykti that’s advanced to phase 2, placing a premium on patience and fiscal responsibility as it pours money into R&D. According to the company’s first-quarter report, R&D spending increased more than 14% compared to the first quarter of 2021. Luckily for Legend, it had nearly $800 million in cash and investments as of March 31, and at that point had yet to accrue revenue from Carvykti.