May 6, 2023 Source: drugdu 151
Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has entered into a worldwide collaboration and licensing agreement with Cellular Biomedicine Group (CBMG) for a pair of CAR T-cell therapy candidates.
Under the terms of the agreement, Janssen will pay CBMG an upfront fee of $245m, with the Chinese biotech also eligible for certain milestone payments, as well as tiered royalties.
In exchange, CBMG will grant Janssen a worldwide licence to develop and commercialise the CAR-T assets, except in Greater China, with the companies set to negotiate an option for the pharma to commercialise the products in the China territory.
The investigational CAR-Ts have shown promising early-stage results in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL), the companies said, with the majority of patients in the studies having diffuse large B-cell lymphoma (DLBCL).
DLBCL is the most common type of aggressive lymphoma, accounting for approximately one-third of B-cell lymphomas globally.
The disease is characterised by the uncontrolled rapid growth of a type of immune cell called lymphocytes, with CD20 and CD19 antigens commonly found on the surface of the cells.
One of CBMG’s therapies, C-CAR039, targets both CD19 and CD20 antigens and is being assessed in a phase 1b study in the US in relapsed or refractory DLBCL.
C-CAR039 has already received regenerative medicine advanced therapy and fast-track designations from the US Food and Drug Administration.
The second candidate, C-CAR066, targets CD20 and has a similar phase 1b study due to begin later this year.
Yusri Elsayed, vice president, disease area leader, haematologic malignancies, Janssen Research & Development LLC, said: “The CBMG team has discovered differentiated cell therapies with clinically validated CD20 CAR constructs, and we look forward to harnessing our expertise, capabilities and scale to lead the global development of these innovative CAR-T products.”
Also commenting on the agreement, Tony (Bizuo) Liu, chairman and chief executive officer of CBMG, said: “The updated clinical data for both C-CAR039 and C-CAR066 continues to support the view that both CAR-T assets have the potential to be best in disease and best in class in relapsed or refractory NHL to address significant unmet medical needs globally”.
“We are thrilled that through this collaboration we will be able to expand the potential of these promising NHL drug candidates in the hope of helping patients worldwide.”
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