AbelZeta announces updated clinical results for C-CAR031 (AZD7003), a GPC3-targeted armored autologous CAR-T in advanced hepatocellular carcinoma at ESMO Congress 2026

• Updated Phase I results of C-CAR031 in 36 heavily pretreated HCC patients demonstrated a disease control rate of 91.7% across all dose levels, with deep tumor shrinkages translating into an encouraging survival signal and a manageable safety profile, supporting further clinical development.

ROCKVILLE, Md., Nov. 9, 2026 /PRNewswire/ -- AbelZeta Inc. ("AbelZeta" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, has announced updated clinical results from the first-in-human study investigating C-CAR031 (now known as AZD7003), a novel glypican-3 (GPC3)-targeted armored CAR-T in advanced hepatocellular carcinoma (HCC), presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

The presentation reported an encouraging survival signal and antitumor activity in 36 heavily pretreated patients with advanced HCC, who had received a median of four prior lines of systemic therapy. As of the August 15, 2026 data cutoff date, median follow-up was 14.9 months.

Presentation Details

• Abstract: 1680RO
• Title: Phase I study of C-CAR031 (AZD7003), a GPC3-targeted TGFβRIIDN armored autologous CAR-T, in advanced hepatocellular carcinoma: Updated results
• Session: Rapid Oral Presentation – Cell Therapy
• Date: October 26, 2026

Key Clinical Results

• Baseline Characteristics: The study enrolled advanced HCC patients with the majority (94.4%) of patients at Barcelona Clinic Liver Cancer (BCLC) Stage C, with extrahepatic lesions (83.3%). Patients were heavily pre-treated with a median of 4 lines of systemic therapies, with the majority (91.7%) of patients having received both immunotherapy and VEGF(R) inhibitors before enrollment.
• Safety: Most patients experienced mild (Grade 1 or 2) cytokine release syndrome (CRS), with two patients (5.6%) at the highest dose level experiencing Grade 3 CRS. No dose-limiting toxicities (DLTs), immune effector cell-associated neurotoxicity syndrome (ICANS), or immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) were observed. Two patients (5.6%) at the highest dose level had interstitial lung disease (ILD).
• Clinical activities: The confirmed overall response rate was 44.4% and the disease control rate (DCR) was 91.7% across all 4 dose levels. At the recommended phase 2 dose (RP2D) of 2.5x10^6 cells/kg, the DCR was 100% with a 12-month overall survival rate of 75.6%. Previously published data reported that tumor regression was observed in 32/36 patients (88.9%) across both intrahepatic and extrahepatic lesions.

"These updated results provide further encouraging clinical evidence of the potential of C-CAR031/AZD7003 to address significant unmet medical needs in advanced hepatocellular carcinoma, particularly among patients who have exhausted multiple lines of treatment," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "We are proud of the important role AbelZeta has played in advancing this program, combining AstraZeneca's innovative CAR-T design and armoring technology with our extensive cell therapy engineering, manufacturing, and clinical development capabilities. We are pleased to see the continued clinical progress of this program under AstraZeneca's global leadership and look forward to its further development for patients with HCC."

C-CAR031/AZD7003 is an autologous GPC3-targeting CAR-T therapy designed by AstraZeneca using its dominant-negative transforming growth factor-beta receptor II (dnTGFβRII) armoring platform, that is designed to overcome immunosuppression within the solid tumor microenvironment. The first-in-human clinical study was conducted by The First Affiliated Hospital, Zhejiang University School of Medicine, led by Professor Tingbo Liang and Dr. Qi Zhang.

In January 2026, AbelZeta announced an agreement under which AstraZeneca acquired AbelZeta's remaining development and commercialization rights to C-CAR031 in China. AstraZeneca now holds sole worldwide rights to develop, manufacture, and commercialize the investigational therapy, while AbelZeta remains eligible to receive development, regulatory, and commercial milestone payments, as well as royalties under the applicable agreements.

About AbelZeta Inc.
AbelZeta is a clinical-stage biopharmaceutical company based in Rockville, Maryland. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against oncology and inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence, with a pipeline comprised of multiple CAR-T therapies.

Forward-Looking Statements
Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to numerous factors. Forward-looking statements are based on the current beliefs and management's expectations and are subject to significant risks and uncertainties outside of AbelZeta Inc.'s ("AbelZeta" or the "Company") control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, AbelZeta does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:
Sarah Kelly
Director of Communications
AbelZeta Inc.
+1 (240) 552 5870
[email protected]
www.abelzeta.com

SOURCE AbelZeta Inc.