Cellular Biomedicine’s investigational CD-20-directed autologous CAR-Ts are in Phase 1 trials (or anticipating the start of Phase 1 trials) for relapsed/refractory non-Hodgkin’s lymphoma (NHL).
Janssen – one of the Janssen Pharmaceutical Companies of J&J – says the collaboration will enhance its portfolio in B-cell malignancies and strengthen its position in hematology; while demonstrating its commitment to developing, manufacturing and commercializing cell therapies.
IND and fast track designations
Janssen will pay $245m upfront to develop and commercialize C-CAR039 and C-CAR066 in geographic territories outside of China (with undisclosed future milestone payments based on development, regulatory and sales milestones, as well as tiered royalty payments on worldwide net trade sales outside Greater China).
Furthermore, the two parties will negotiate an option for Janssen to commercialize the products in China.
Globally, it is estimated that more than 540,000 new cases of NHL occurred in 2020, and more than 259,000 people died from the disease. DLBCL is most common in the US and Western Europe, and the incidence has increased by more than 50% in 20 countries since the late 20th century.
Most B-cell lymphomas are NHL, and DLBCL is the most common.
Other types of B-cell malignancies include Burkitt lymphoma, mantle cell lymphoma (MCL), and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
The investigational CD20-directed autologous CAR-Ts have demonstrated promising overall and complete response rates in Phase 1 studies in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL) in China, with the majority of study participants having diffuse large B-cell lymphoma (DLBCL), the most common type of aggressive lymphoma accounting for approximately one-third of B-cell lymphomas globally.
DLBCL is characterized by the uncontrolled rapid growth of a type of immune cell called lymphocytes. CD20 and CD19 are antigens commonly found on the surface of the cells. As many as half of patients with DLBCL eventually become refractory to first-line treatment and require additional treatment options.
C-CAR039 is a novel bispecific CAR-T therapy targeting both CD19 and CD20 antigens and has received US Food and Drug Administration (FDA) Investigational New Drug (IND) clearance, and Regenerative Medicine Advanced Therapy and Fast Track designations for the treatment of patients with relapsed or refractory (R/R) DLBCL.
A Phase 1b study in the US evaluating C-CAR039 in the treatment of patients with R/R DLBCL is underway.
Meanwhile, C-CAR066 is an optimized novel CD20 targeted CAR-T therapy that has also received IND clearance, and a Phase 1b study in patients with R/R DLBCL is anticipated to begin in the second half of 2023.
“Our innovation strategy is agnostic to the source of breakthrough science, platforms, targets and medicines from the global life science ecosystem,” said Yusri Elsayed, M.D., M.HSc., Ph.D., Vice President, Disease Area Leader, Hematologic Malignancies, Janssen Research & Development, LLC.
“The Cellular Biomedicine Group 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.”
The transaction is expected to close in the second quarter of 2023.