On June 4, 2021 (EST), OriginCell Therapeutics (Shanghai) Co., Ltd., 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. Preliminary results from the study show promising safety and efficacy of Ori-CAR-001 in patients with GPC3-positive relapsed/refractory HCC.
A breakthrough Cell Therapy against Solid Tumors
As of March 10, 2021, a total of 11 patients were enrolled into this study. All subjects had advanced HCC and had failed prior lines of treatment including chemotherapy, TACE, and targeted therapies. All subjects had BCLC stage C (late stage) HCC except for one subject with stage B (mid stage). All subjects had multiple lesions, of which 6 (54%) had distant metastasis. Two subjects dropped out early and were not evaluable. 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%. A partial response lasting for more than 6 months was observed in Subject 007 at the time of data cutoff, whose tumor volume was reduced by more than 80% one month post cell therapy infusion. (As of June 2021, this subject had exceeded 8 months of disease control, follow-up is still ongoing). Good tumor response was also seen in Subject 012, who has advanced and diffuse massive HCC and joined the study after failing in radiotherapy, targeted drug and 12 times of TACE.
Barcelona Clinic Liver Cancer (BCLC) is a liver cancer staging system developed by the European Association for the Study of Liver, to help assess patients' conditions, select the right therapies for the right patients, and predict patients' prognosis. The BCLC system classifies HCC mainly as stages of 0, A, A1,A2,A3,A4, B, C,and D.
On day 28 post infusion with CAR-T cells, the target tumor lesion decreased from 133mm in diameter at baseline to 9mm, a reduction of more than 93%. Currently, the subject is being evaluated for month 3 post CAR-T cell infusion, MRI scan showed near complete tumor response. In addition, AFP level (alpha-fetoprotein, a specific tumor marker for primary liver cancer) decreased from a baseline value of >80,000/ng/ml to 1148.9 ng/ml on month 1, and to 746.7 ng/ml at month 3 post infusion (normal range <40ng/ml), demonstrating significant preliminary efficacy of Ori-CAR-001 in patients with advanced HCC.
Good Safety Profile
Ori-CAR-001 CAR-T infusion demonstrated good safety and tolerability in 11 patients. Cytokine release syndrome (CRS) was observed in 9 patients (7 cases grade 1-2 and 2 cases grade 4), which were resolved after treatment with steroids and tocilizumab. No neurotoxicity was observed.
Regarding the results from this exploratory study, Professor Ji Jiansong, principal investigator of Lishui Central hospital, who is also Chief scientist of the National Key R&D Program, director of Key Laboratory of Imaging Diagnosis and Minimally Invasive Intervention Research of Zhejiang China, said, "There is currently no effective treatment for relapsed/refractory hepatocellular carcinoma. Many challenges such as the tumor micro environment is difficult to overcome and have limited the therapeutic effects of cell therapy in solid tumors. However, Ori-CAR-001, developed by OriginCell Therapeutics, has managed to achieve an objective response rate of 44% and a disease control rate of 77% in patients with relapsed/refractory HCC, demonstrating a level of safety and anti-tumor activity that cannot be achieved by currently available drugs. Given its preliminary promising efficacy and safety data, we are confident in the future development prospects of Ori-CAR-001 and will continue our research studies. We take great pride and hope Ori-CAR-001 will one day become a new treatment option for patients with advanced HCC.
Dr. He Xiaowen, co-founder and chief scientific officer of OriginCell Therapeutics, said, " Although Immuno-cell therapies have produced remarkable clinical responses in hematological tumors, they have limited efficacy against...
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