OriCell Therapeutics Receives Implied License from NMPA for Ori-C101 IND Application


SHANGHAI, Sep. 21, 2022 -- OriCell Therapeutics (Shanghai) Co., Ltd. ("OriCell" or "the Company”) has formally received a license from China’s National Medical Products Administration (NMPA) for its Ori-C101 Investigational New Drug (IND) application according to information from NMPA. Obtaining the license signals that OriCell’s first proprietary CAR-T product targeting Glypican-3 (GPC3) for the treatment of advanced liver cancer is ready for domestic clinical trials.


GPC3, a heparan sulfate proteoglycan (HSPG) that attaches to the cell surface, is highly expressed in hepatocellular carcinoma (HCC) but is not expressed or rarely expressed in normal tissues, making it a highly-specific target in HCC. GPC3 regulates cell proliferation signals by combining several growth factors, including Wnt, fibroblast growth factors (FGFs) and insulin-like growth factors (IGFs), and plays an important role in the proliferation and differentiation of embryonic cells. These findings provide a key theoretical basis for GPC3's application in the diagnosis, clinical management, and molecular targeted therapies for HCC.

With the highly specific, high-affinity fully human anti-GPC3 antibody and the unique signal activation domain element, Ori, that has independent intellectual property rights filed, Ori-C101 is intended to treat adult patients with advanced HCC. Results from the investigator-sponsored Phase I study (ChiCTR1900028121) evaluating Ori-C101 in patients with advanced liver cancer, launched in China in August 2019, were publicly announced at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

"Receiving this implied license from NMPA signifies that OriCell, an innovative pharmaceutical company, has entered the clinical development stage. The firm has been committed to addressing unmet clinical treatment needs through the development of innovative drugs, especially cancer therapies,” said OriCell Therapeutics chairman and CEO Yang Huanfeng. “With the original mission in mind, we believe that we, by overcoming obstacles and challenges, can promote the clinical development and mass production of Ori-C101, a therapy for patients with advanced HCC. In addition, we plan to continue developing further innovative, safe, and effective CAR-T products that are expected to benefit a wider range of patients and their families."

OriCell hit several milestones since the beginning of this year. At the 2022 ASCO Annual Meeting held in June, the Company, in an oral presentation, reported positive results from the Phase I POLARIS study, an investigator-sponsored study evaluating OriCAR-017, an autologous GPRC5D-directed CAR-T cell, in patients with relapsed/refractory multiple myeloma (RRMM). This was the first time that clinical data for a GPRC5D-directed CAR-T therapy had been published in China. Subsequently, OriCell announced the completion of over US$120 million in Series B financing, demonstrating the firm’s high recognition among market players despite the challenges presented by both the weak capital market and the ongoing Covid-19 pandemic.

About Ori-CAR

OriCell Therapeutics' proprietary signal activation domain element, Ori, can exponentially enhance the expansion efficiency of memory immune cells, effectively breaking through the physical barriers of the extracellular matrix in TME (tumor microenvironment), resisting the immunosuppressive tumor microenvironment, significantly enhancing the anti-tumor activity and durability of CAR T-cells in vivo, and preventing recurrence. Data from the Phase I POLARIS clinical trial conducted by investigators of OriCAR-017 (autologous, GPRC5D-directed CAR T-cell therapy), another core product of OriCell Therapeutics for the treatment of relapsed refractory multiple myeloma (RRMM) demonstrated good safety and efficacy (with a 100% ORR and a 100% negative MRD 10-5 over 28 days). Oral presentations on the results of the study were given at both the 2022 ASCO and 2022 EHA Annual Meetings.