On December 14, 2023 AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, reported an amendment of its worldwide collaboration and license agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company (Press release, AbelZeta, DEC 14, 2023, View Source [SID1234638557]). Under the amended agreement, Janssen will have the option to obtain exclusive commercialization rights in China for CD20-directed chimeric antigen receptor T (CAR-T) C-CAR039 and C-CAR066, which are being studied for the treatment of Non-Hodgkin Lymphoma (NHL).
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"As presented recently at the 65th ASH (Free ASH Whitepaper) Annual Meeting, the clinical data for both C-CAR039 and C-CAR066 continue to support the potential of both assets to be best in disease in relapsed or refractory (r/r) NHL," said Tony (Bizuo) Liu, Chairman and CEO of the Company. "The Centre for Drug Evaluation in China has approved the Investigational New Drug (IND) application for C-CAR039, and we are currently conducting the Phase 1b study. We are excited to leverage AbelZeta’s clinical development and product manufacturing capabilities together with Janssen’s global commercialization expertise to maximize the potential of C-CAR039 and C-CAR066 to bring innovative and life-changing therapies to patients in China and worldwide."
Under the terms of the agreement, Janssen will pay AbelZeta Pharma an option exercise fee, and AbelZeta Pharma is eligible to receive commercialization and sales milestones.
About the Studies
C-CAR039 is a novel bispecific CAR-T therapy targeting both CD19 and CD20 antigens and has received U.S. 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/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). A Phase 1b study in the U.S. evaluating C-CAR039 in the treatment of patients with r/r DLBCL is underway.
C-CAR066 is an optimized, novel CD20 targeted CAR-T therapy that has also received U.S. FDA IND clearance, and a Phase 1b study in patients with r/r DLBCL, including r/r to CD19 CAR-T treatment, is underway in the U.S.
About NHL and DLBCL
Non-Hodgkin Lymphoma (NHL) is the most common hematological, or blood malignancy worldwide. NHL ranked as the 5th to 9th most common cancer in most countries globally, with an estimated 544,000 new cancer cases and 260,000 cancer deaths in 2020.1
Diffuse large B-cell lymphoma (DLBCL) is a common and aggressive form of non-Hodgkin lymphoma that accounts for one out of every three cases of NHL. Despite available frontline treatment, many patients will experience a relapse or have refractory (resistant to treatment) disease, for which there are limited treatment options and a high risk of mortality. For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.