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AbelZeta Pharma Reveals Long-Term Efficacy of C-CAR039 at EHA 2025

AbelZeta Pharma, Inc., a pioneering player in the biopharmaceutical industry focusing on innovative cell-based therapies, showcased promising long-term outcomes for its bispecific CAR-T product, C-CAR039, during the European Hematology Association (EHA) 2025 Congress held in Milan. The data pertains to patients suffering from relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL), marking a significant milestone in cancer therapy development.

Overview of C-CAR039

C-CAR039, also known as Prizloncabtagene Autoleucel, is a dual-targeting CAR-T therapy that addresses both CD19 and CD20 antigens. This innovative approach not only aims to improve therapeutic effectiveness but also seeks to diminish the likelihood of antigen escape, a prevalent issue in B-cell malignancies. By targeting multiple antigens, C-CAR039 is positioned as a promising next-generation treatment for patients with aggressive forms of lymphoma.

Key Findings from the Clinical Study

The clinical analysis presented at EHA 2025 reported the following key outcomes:

• - The overall response rate (ORR) among the examined patients reached an impressive 91.5%.
• - The complete response (CR) rate was recorded at 85.1% overall, with 90.7% ORR and 86.0% CR specifically noted in patients diagnosed with large B-cell lymphoma (LBCL).
• - Median follow-up lasted 45.5 months, and key metrics such as median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) rates were not yet reached at this time.
• - The Kaplan-Meier estimates of the 48-month PFS rate stood at 52.5% for all patients and 53.4% for LBCL patients, while the OS rates were 65.4% and 66.7%, respectively.

Safety Profile

The safety results were also noteworthy.

• - The incidence of cytokine release syndrome (CRS) of any grade was documented at 93.8%, with only 2.1% reporting grade ≥3 CRS.
• - The incidence of immune effector cell-associated neurotoxicity syndrome (ICANS) was 6.3%, with no severe cases reported.
• - Furthermore, no new safety signals were indicated following longer-term follow-up of the patients.

These findings present a strong argument for the continuing development of C-CAR039 as it emphasizes both its safety and its capacity to induce deep, durable responses in patients with R/R B-NHL, especially in the LBCL subset.

Statements from Leadership

Tony Liu, Chairman and CEO of AbelZeta, expressed his optimism regarding these long-term clinical outcomes, noting, "The data for C-CAR039 is deeply encouraging, further highlighting our commitment to creating transformative therapies that meet significant unmet medical needs within the realm of cancer."

Dr. Yihong Yao, Chief Scientific Officer at AbelZeta, added insights into the unique benefits of the dual targeting approach, emphasizing that C-CAR039's ability to simultaneously address CD20 alongside CD19 allows for more effective tissue penetration and overall B-cell depletion, ultimately leading to the promising durable responses observed in the study.

Future Directions

The results at EHA 2025 enhance support for the late-stage clinical development of C-CAR039 as a next-generation treatment form for patients facing unyielding B-cell malignancies. AbelZeta's previous presentations of data at both the 65th American Society of Hematology (ASH) Annual Meeting and EHA 2024 reveal a rigorous and ongoing commitment to advancing CAR-T therapies.

AbelZeta is forging ahead with clinical studies and collaborative efforts to address crucial areas in cancer treatments through further trial phases and potential partnerships, bolstering its role in leading-edge oncology therapeutics.