Ori-C101 / Oricell - LARVOL DELTA

Phase I study of Ori-C101, an armored GPC3-directed CAR-T, in patients with advanced hepatocellular carcinoma (HCC). (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT05652920 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

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