Johnson & Johnson’s Janssen Biotech subsidiary has just paid $245 million upfront for licensing prospects for B-cell tumors from Cellular Biomedicine, demonstrating that the company has no plans of slowing down in its pursuit of developing a new generation of CAR-T medicines for cancer.
Two CD20-directed CAR-Ts from the Chinese biotech, both in early-stage clinical development, will be covered by the agreement. These CAR-Ts have the possibility of being used to treat different types of non-Hodgkin’s lymphoma, such as diffuse large B-cell lymphoma (DLBCL).
The news comes just a few months after Johnson & Johnson withdrew from another CAR-T partnership with Fate Therapeutics, which was initially signed in 2020 and encompassed an upfront involvement of $100 million with a potential value of up to $3 billion covering CAR-T and CAR-NK therapies.
Carvykti (ciltacabtagene autoleucel) is J&J’s only CAR-T treatment that has been authorized so far. It is a BCMA-directed treatment for multiple myeloma and was developed in partnership with Legend Biotech, a Chinese pharmaceutical company.
With the Cellular Biomedicine candidates, big pharma will start to take over territory in NHL that has already been carved out by Gilead Sciences and Novartis with Yescarta and Kymriah. Bristol-Myers Squibb, with Breyanzi (lisocabtagene maraleucel), which is a newer drug, has also made its mark in this particular territory.
C-CAR066, an anti-CD20 CAR-T, and C-CAR039, a bispecific treatment that addresses both CD20 and CD19, are the two contenders that have been licensed. A phase 1b trial using the bispecific is now being conducted in the U.S. on patients with relapsed or refractory DLBCL, and a study of a similar nature including C-CAR066 is scheduled to begin before the conclusion of the year.
Cellular Biomedicine, headquartered in Shanghai, claims that the FDA has already designated C-CAR039 as an advanced treatment for regenerative medicine and as a candidate for the fast-track program. The CAR-Ts produced by the company are engineered with a “second-generation” CAR design that makes use of a lentiviral vector to change T cells. The goal of this design is to improve upon the effectiveness and safety of the initial wave of CAR-T treatments.
The full potential value of the licensing transaction has not been made public; nevertheless, in exchange for the upfront payment, Janssen has been granted a license to both CAR-Ts around the globe, with the exclusion of Greater China. In the event that the medicines make it through the approval stage, the pharmaceutical company does, however, have the option to purchase commercialization rights in Greater China.
A recent revelation of clinical data for Carvykti shows that J&J’s initial entry into the CAR-T category has the potential to be a huge success. J&J has suggested that sales of the therapy might ultimately peak at over $5 billion. In the first three months of this year, it generated $72 million on its sales of the CAR-T.
Before forming its partnership with J&J, Cellular had also worked with Novartis to distribute Kymriah, the first CAR-T cell treatment in China to be authorized in the U.S.