ASCO 2026 | Oricell's GPC3 CAR-T Ori-C101 Hits 66.7% ORR in Late-Line HCC, Signaling Best-in-Class Potential

Hepatocellular carcinoma (HCC) remains a critical global health challenge, particularly in China, which accounts for more than one-third of the world's over 800,000 annual deaths from the disease. While frontline treatments have evolved, options for patients failing second-line therapy are scarce, with historical ORRs typically below 13%.

Oricell's registrational Phase Ib BEACON study challenges this status quo. As of April 3, 2026, among 18 efficacy-evaluable patients with advanced, heavily pretreated HCC:

• Overall ORR reached 50%.
• At the Recommended Phase 2 Dose (RP2D), ORR surged to 66.7%, with a disease control rate (DCR) nearing 90%.
• Durability was profound: One patient achieved a complete response (CR) lasting 24 months.
• Safety was manageable: No immune effector cell-associated neurotoxicity syndrome (ICANS) or off-tumor toxicity was observed, with cytokine release syndrome (CRS) contained within controllable grades.

Long-Term Validation: From 2021 ASCO Poster to Registrational Data

Notably, as early as 2021, Oricell's investigator-initiated trial (IIT) data for Ori-C101 were selected for a poster presentation at ASCO. At that time, a striking response was observed in a late-line HCC patient following a single infusion: the first efficacy assessment showed a partial response (PR), with target lesions shrinking by 96.1% (from 155.45 mm to 6 mm) and alpha-fetoprotein (AFP) levels plummeting by 99.1% (from >80,000 ng/mL to 742 ng/mL). The patient achieved an overall survival (OS) of nearly three years.

The now-unveiled registrational clinical data further validate the clinical value of Ori-C101, reinforcing the consistency and reproducibility of Oricell's approach from early proof-of-concept to pivotal trials.

Technology Backbone: A "Three-in-One" Engine Addressing Solid Tumor Barriers

Ori-C101's exceptional performance stems from Oricell's proprietary technology platforms, systematically addressing major challenges in CAR-T therapy for solid tumors: antigen heterogeneity, immunosuppressive tumor microenvironment (TME), and manufacturing efficiency.

1. Ori®Ab (AI-Powered Antibody Discovery Platform）
The Ori®Ab platform features a massive library comprising up to 10¹¹ fully human scFv and nanobody sequences. Utilizing a live-cell-based high-throughput screening strategy, the platform specifically identifies native conformational antigens, including challenging targets such as GPCRs, thereby avoiding the false-positive risks associated with purified protein-based screening. Furthermore, AI-assisted algorithms have compressed the antibody discovery and screening cycle from a traditional 12 months to just 3 months, significantly enhancing both efficiency and quality. The resulting high-specificity, optimally affine GPC3 antibody sequence equips Ori-C101 with a robust safety profile, effectively minimizing the risk of off-tumor toxicity.

2. Ori®Armoring (Structure-Enhanced Cell Platform)
The Ori®Armoring platform incorporates customized "armoring" elements designed to modulate T cell metabolic pathways and signal transduction based on the specific tumor microenvironment (TME). This engineering strategy enriches young, stem-like memory T cell subsets (Tscm), significantly enhancing the in vivo persistence of Ori-C101. By remodeling the local immune microenvironment, the platform effectively reverses immunosuppression, converting "cold tumors" into "hot tumors," thereby promoting the infiltration and activation of effector T cells. This approach overcomes the dual bottlenecks of the immunosuppressive TME and T cell exhaustion in solid tumors, ensuring durable, long-term responses. Additionally, the platform integrates logic-gating strategies—including 'OR' gating to prevent antigen escape and 'AND' gating to improve targeting precision—which collectively optimize the therapeutic index of the product.

3. Ori®OnGo: Flexible Manufacturing Platform (Classic / Rapid / In Vivo)
Built on a "Quality by Design" (QbD) philosophy, this platform includes proprietary manufacturing technologies. The rapid manufacturing process reduces ex vivo culture time to just 3 days, significantly improving productivity and lowering cost of goods (COGS). It ensures final product cell viability consistently above 95%, and compresses the vein-to-vein time to within 15 days. Moreover, the platform's in vivo CAR-T product design and process capabilities open broader future applications for CAR-T therapy. This integrated manufacturing approach enables scalable, cost-effective production while maintaining product quality and patient access.

Executive Outlook

"Securing a third ASCO oral presentation validates our integrated platform strategy," said Dr. Helen Yang, Co-Founder and CEO of Oricell. "We are accelerating the pivotal Phase II development to bring this therapy to market. We are also actively seeking global partnerships to expand the reach of our technology and deliver hope to patients worldwide."

About Oricell Therapeutics

Oricell is a clinical-stage global biotechnology company dedicated to becoming a pioneer in tumor immunotherapy. Focused on solving unmet medical needs in oncology and immunology, by powering a proprietary technology triad: Ori®Ab (antibody discovery), Ori®Armoring (T-cell enhancement), and OnGo CMC (rapid manufacturing), Oricell has successfully established a robust pipeline targeting both solid and hematological tumors. The company's clinical translation capabilities have been recognized globally, with multiple data readouts selected for oral presentations at major international conferences including ASCO and EHA, and published in top-tier journals such as The Lancet Haematology. For more information, visit www.oricell.com.

Forward-Looking Statements

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SOURCE Oricell Therapeutics Holdings Limited