On August 1, 2022 OriCell Therapeutics (Shanghai) Co., Ltd. ("OriCell" or "the Company") reported the completion of Series B financing totaling over US$120 million (Press release, OriCell Therapeutics, AUG 1, 2022, View Source [SID1234617197]). This round of financing was jointly led by Qiming Venture Partners and Quan Capital with participation by several leading international and Chinese investment funds, as well as existing shareholder C&D Emerging Capital. 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.

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Helen Yang, Chairman and CEO of OriCell, stated, "We are grateful to our new and existing investors for their continued support in OriCell. We have achieved a number of significant milestones in terms of clinical development of our CAR-T and partnered bispecific antibody programs, as well as continued to strengthen our senior management team. We look forward to delivering more innovative discoveries and clinical milestones in the next three years. In today’s open, inclusive, and dynamic innovative pharmaceutical ecosystem in China, we endeavor to become a world leading cell therapy company with a broad vision that can integrate seamlessly into the global market."

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. In data published at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, Ori-C101 demonstrated superior safety and efficacy in patients with GPC3-positive advanced liver cancer with an objective response rate (ORR) of 44% and disease control rate (DCR) of 78%. The longest follow-up thus far is more than 22 months, with additional follow-ups ongoing.

OriCAR-017, China’s first GPRC5D CAR-T product developed by OriCell for the treatment of relapsed and refractory multiple myeloma (RRMM) confirmed the product’s potential with clinical results from the investigator-initiated phase I trial (POLARIS) was presented in an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper)2022 annual meetings, respectively. In all patients, the majority of adverse events (AE) were transient, manageable, and reversible. Only Grade 1/2 cytokine release syndrome (CRS) was observed with no dose limiting toxicity (DLT), neurotoxicity, or AE-related death. Responses were durable and deepened over time with 100% ORR and 100% MRD negative rate, including in 5 prior BCMA CAR-T relapsed patients. All patients were progression-free and followed up without additional therapy by the cutoff date of April 30, 2022. Presently, OriCell is accelerating its registration and clinical development in China and the United States.

An exclusive global license agreement for OriBs-001 (ATG101) was reached with Antengene in 2019. OriBs-001 (ATG101) is a PD-L/4-1BB bispecific antibody and has received the implied approval from the Center for Drug Evaluation (CDE) in China in March this year after receiving IND from the U.S. Food and Drug Administration (FDA) and Clinical Trials Notification (CTN) from the Australian Therapeutic Goods Administration (TGA).

In March this year, Dr. Weidong Cui joined the company as Chief Technology Officer. Dr. Cui has more than 20 years of experience in process development, GMP production and commercial operation of cell therapy drug products. As the former CTO at Fosun Kite, he has led the team to successfully complete the GMP production, IND registration, and NDA registration of the first CAR-T drug in China.