Ori-C101 / Oricell - LARVOL DELTA

Objective response rates with Ori-C101, an armored GPC3-directed CAR-T, in heavily pretreated advanced HCC: Updated results from the phase Ib BEACON study. (ASCO 2026) - P1/2 | "Ori-C101 demonstrates a manageable safety profile and compelling, durable anti-tumor activity in GPC3+ advanced HCC. The combination of high ORR and prolonged survival benefit distinguishes Ori-C101 as a potential paradigm-shifting therapy for patients who have failed standard-of-care treatments. A phase II/III study is currently underway to further confirm the efficacy and asses the safety of Ori-C101."

CAR T-Cell Therapy • Clinical • Metastases • P1 data • Hepatocellular Cancer • GPC3

Phase I data of Ori-C101: robust efficacy and manageable safety (PRNewswire) - "Results from the Phase I BEACON study were featured as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting....Objective response rate (ORR): 50% across the evaluable population; 66.7% in the recommended Phase II dose (RP2D) cohort; 100% in the highest dose cohort (DL4). Speed of response: 89% of responders had already achieved objective response by their first post-infusion assessment, with marked tumour shrinkage. Overall survival (OS): Median OS of 21.4 months in the overall population; 12-month survival rate of 69.3% - more than double the roughly 10.6-month historical median seen with available second-line agents, heralding a potential new era of long-term survival for patients with advanced HCC."

P1 data • Hepatocellular Cancer

OriCell's GPC3 CAR-T Receives NMPA Clearance for Confirmatory Phase II Trial in Late-Line Advanced Hepatocellular Carcinoma (PRNewswire) - "The study is designed as a prospective, randomised, open-label, multi-centre registration trial evaluating the efficacy and safety of Ori-C101 in patients who have failed two or more prior lines of therapy."

New P2 trial • Hepatocellular Cancer

Oricell Therapeutics Announces US$70M Initial Closing of Series C Financing, to Accelerate Global Development of Solid Tumor CAR-T Therapies (PRNewswire) - "Proceeds will accelerate Oricell's global expansion and clinical development, while strengthening its technological capabilities and paving ways to commercialization....Oricell has generated proof-of-concept (POC) clinical data across multiple pipeline CAR-T products. Its lead program, Ori-C101, is an autologous GPC3-targeted CAR-T therapy for advanced hepatocellular carcinoma (HCC)....The innovative secreting CAR-T, OriC902, has shown groundbreaking efficacy and durability in ultra-late-line and difficult-to-treat solid tumor patients."

Financing • Hepatocellular Cancer

Phase I study of Ori-C101, an armored GPC3-directed CAR-T, in patients with advanced hepatocellular carcinoma (HCC). (ASCO 2025) - P=N/A, P1/2 | "These preliminary data showed Ori-C101 has manageable safety profile and exciting efficacy with encouraging sign of good durability. Currently, more pts have been enrolled at dose expansion to confirm the DLs of RP2D. More information will be presented at coming ASCO conference."

Clinical • Metastases • P1 data • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

Yuanqi Bio was invited to attend the JP Morgan Global Healthcare Annual Conference for the second time to report the latest progress of OriCAR-017 and Ori-C101 [Google translation] (Oricell Press Release) - "In his speech, Tom Farrell, the new president of YuanQi Bio, gave a detailed introduction to the company's proprietary platform, the latest progress of its R&D pipeline, its global layout and future development plans...In the field of multiple myeloma, OriCAR-017, the core project of Yuanqi Bio, as a CAR-T therapy targeting GPRC5D, continues to demonstrate best-in-class clinical potential among similar targeted therapies in the world...At the same time, Yuanqi Bio has also made significant progress in the field of solid tumors. At the conference, it presented the best-in-class data of another core project, Ori-C101, which is expected to bring breakthrough efficacy and lasting treatment effects to hepatocellular carcinoma (HCC) patients around the world....The company will accelerate the clinical development of OriCAR-017 in the United States and plans to advance multiple next-generation CAR-T therapies to the clinical validation stage in China."

Pipeline update • Hepatocellular Cancer • Multiple Myeloma • Solid Tumor

Dual targeting liver cancer by GPC3 CAR-T cells secreting a bispecific T cell engager antibody for an intracellular tumor antigen AFP (SITC 2023) - "Methods In this study, we engineered GPC3 CAR-T cells (OriC101) to secrete a bispecific T cell engager (BiTE) composed of a TCR mimic antibody targeting AFP-MHC complex (OriA373). Conclusions Hence, by leveraging dual orthogonal cytotoxic modalities with distinct specificities targeting surface and intracellular tumor-associated antigens, we have developed a promising strategy to overcome resistance to CAR-T cell therapy not only in liver cancer but also in other cancer types. Our results, demonstrating the superior activation and memory phenotype of GPC3 CAR-T cells secreting AFP-BiTE (OriC633–05), as well as its significantly enhanced anti-tumor activity against liver cancer cells with low GPC3 expression, and the potential for improved efficacy against liver cancer with high GPC3 expression, highlight the promising potential of this approach (figure 5)."

CAR T-Cell Therapy • IO biomarker • Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor • HLA-A

Oricell Closes $45M Series B1 Financing to Expand Development of Key Products (PRNewswire) - "Oricell Therapeutics Co., Ltd...announced the close of a $45M Series B1 investment round after the completion of a $125M Series B fund-raise in July 2022....Since the debut of Oricell's first key product Ori-C101 at the 2021 American Society of Clinical Oncology ('ASCO') Annual Meeting, the Company has been overcoming many difficulties and made unremitting efforts to achieve all the expected milestones....With this new funding, the Company is now well-positioned to expand its products to the U.S., specifically OriCAR-017, a GPRC5D CAR-T therapeutic that treats relapsed and refractory multiple myeloma, which is a product currently on the stage of IND enabling both in the US and China."

Financing • Hematological Malignancies • Multiple Myeloma • Oncology

Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC (clinicaltrials.gov) - P1/2 | N=105 | Recruiting | Sponsor: OriCell Therapeutics Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC (clinicaltrials.gov) - P1/2 | N=105 | Not yet recruiting | Sponsor: OriCell Therapeutics Co., Ltd.

New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • GPC3

OriCell Therapeutics Raises Over $120 Million in Series B Financing Led by Qiming Venture Partners and Quan Capital to Advance Cell Therapies for Cancer Immunology (PRNewswire) - "OriCell Therapeutics...has announced the completion of Series B financing totaling over US$120 million....The new funding will go toward the development of OriCell's cell therapy pipeline, and Company's proprietary discovery platform, as well as the construction of a manufacturing plant for both clinical and commercial purposes....OriCell's Investigational New Drug (IND) submission for Ori-C101, Company's first internally developed CAR-T product targeting GPC3 for the treatment of advanced liver cancer, was accepted by the National Medical Products Administration (NMPA) of China in June of this year."

Commercial • Non-US regulatory • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

OriginCell Therapeutics Presents Positive Results of GPC3 CAR-T in HCC Trial at the 2021 ASCO Annual Meeting (PRNewswire) - P1, N=11; "On June 4, 2021 (EST), OriginCell Therapeutics...together with Lishui Central Hospital affiliated to Zhejiang University and Shanghai Changzheng Hospital, presented the updated data from the on-going trial of Ori-CAR-001, a GPC3 CAR-T cell therapy for the treatment of relapsed/refractory hepatocellular carcinoma (HCC), at the 2021 annual meeting of American Society of Clinical Oncology...Among the 9 evaluable subjects, 4 achieved partial response (PR), 3 achieved stable disease (SD), and 2 had disease progression (PD). The objective response rate was 44.4%, and the disease control rate reached 77.8%."

P1 data • Hepatocellular Cancer • Oncology

[VIRTUAL] An armored GPC3-directed CAR-T for refractory or relapsed hepatocellular carcinoma in China: A phase I trial. (ASCO 2021) - "Patients were pre-conditioned with fludarabine (25̃30 mg/m2) and cyclophosphamide (200̃300 mg/m2) daily for 3 days...Cytokine release syndrome (CRS) was observed in 8 patients, in which 6 at grade 1 or 2 and 2 at grade 4 notably infused with 3 x10e8 both via intravenous route and reversed within 7 days by administering high-dose steroids and tocilizumab... These initial data provide evidence that G3-CAR-ori2 is safe and holds promising antitumor potential, and supports its continuing development in the treatment of r/r GPC3+HCC."

IO biomarker • P1 data • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Inflammation • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • GPC3