Pharma Focus Asia

Abelzeta Announces a Modification to Its Worldwide Collaboration and Licensing Agreement With Janssen, Now Extending to Include China

Friday, December 15, 2023

AbelZeta Pharma, Inc. ("AbelZeta"), a global clinical-stage biopharmaceutical company specializing in the development of innovative cell-based therapeutic products, has recently made adjustments to its collaboration and license agreement with Janssen Biotech, Inc., a Johnson & Johnson subsidiary. This amendment provides Janssen with the option for exclusive commercialization rights in China for CD20-directed chimeric antigen receptor T (CAR-T) therapies, specifically C-CAR039 and C-CAR066, currently under investigation for the treatment of Non-Hodgkin Lymphoma (NHL).

Tony (Bizuo) Liu, Chairman and CEO of AbelZeta, emphasized the promising clinical data for C-CAR039 and C-CAR066, highlighting their potential as leading treatments for relapsed or refractory NHL. C-CAR039 has gained regulatory approval from the Centre for Drug Evaluation in China, and a Phase 1b study is currently underway. The collaboration aims to leverage AbelZeta's clinical and manufacturing capabilities with Janssen's global commercialization expertise to advance these therapies for patients in China and worldwide.

As part of the agreement, Janssen will pay AbelZeta an option exercise fee, and the latter stands to receive commercialization and sales milestones.

C-CAR039 is a bispecific CAR-T therapy targeting CD19 and CD20 antigens, with FDA clearance for Investigational New Drug (IND), and ongoing Phase 1b studies in the U.S. for relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
C-CAR066 is an optimized CD20 targeted CAR-T therapy, also with FDA IND clearance, currently undergoing a Phase 1b study in patients with relapsed/refractory DLBCL in the U.S.

Non-Hodgkin Lymphoma (NHL) is a prevalent hematological malignancy globally, ranking among the most common cancers. DLBCL, a particularly aggressive form of NHL, accounts for a significant portion of cases. Despite frontline treatments, many patients face relapse or refractory disease, necessitating new therapeutic options.

The critical need for innovative therapies is underscored by limited treatment options and high mortality risks for patients with relapsed or treatment-resistant DLBCL. AbelZeta Pharma and Janssen Biotech's collaboration seeks to address this unmet medical need and enhance the outlook for patients facing these challenges.




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