SHANGHAI, NEW JERSEY, Jan 29th, 2024 – Oricell Therapeutics (Oricell), a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for OriCAR-017 for patients with relapsed/refractory multiple myeloma (R/R MM). OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D. The therapy leverages Oricell's proprietary platforms including Ori®Ab antibodies, Ori®CAR construct and unique CMC know-how to achieve optimal binding and superior persistence and anti-tumor efficacy out of rejuvenated CAR-T cells. The IND enables Oricell to initiate the clinical development for OriCAR-017 in the US immediately.
Led by Co-founder & CEO, Helen Yang, and Co-founder & CSO, Dr. Peter He, the executive team represented Oricell and showcased our latest advancements. Peter specifically highlighted the positive strides made with our flagship asset, OriCAR-017, a GPRC5D-targeted CAR-T therapy. Concurrently, he elaborated on the company's significant progress in global development strategy, expressing unwavering confidence in our future path.
Oricell is set to make its presence felt at the 42nd Annual JP Morgan Healthcare Conference. Co-founder and Chief Executive Officer, Ms. Helen Yang, and co-founder and Chief Scientific Officer, Dr. Peter He, will jointly participate in the conference.
We are excited to announce that we have filed IND application of OriCAR-017 to the FDA on this day. Oricell continues to execute strategies and deliver progress on time. In 2023, we completed tech transfer from China to US and filed IND of OriCAR-017 in 7 months since preparation began.
Shanghai, China—August 10, 2023, in a groundbreaking development, Oricell Therapeutics Co., Ltd. ("Oricell") has received the green light for its Investigational New Drug (IND) application of OriCAR-017, a cutting-edge CAR-T cell therapy targeting GPRC5D to combat relapsed or refractory multiple myeloma (R/R MM). This remarkable milestone not only marks the world's first GPRC5D-targeting CAR-T therapy approved in China but also underlines Oricells prowess as a frontrunner in the biotech industry.
SHANGHAI, Feb. 28th, 2023 -- Oricell Therapeutics Co., Ltd (“Oricell” or “the Company”), a China-based innovative pharmaceutical company committed to the development of tumor cellular immunotherapeutics, today announced the close of a $45M Series B1 investment round after the completion of a $125M Series B fund-raise in July 2022.
SHANGHAI, Jan. 31, 2023 - Oricell Therapeutics Co., Ltd (Oricell), an innovative pharmaceutical company committed to the development of clinical-stage oncology cell therapies, today announced publication of data from a clinical study evaluating the efficacy of OriCAR-017, an autologous GPRC5D-directed CAR-T cell therapy, in the treatment of relapsed/refractory multiple myeloma (RRMM) in an article entitled “Phase 1 Open-Label Single-Centre Single Arm Study of GPRC5D CAR T Cells(OriCAR-017) in Patients with Relapsed/Refractory Multiple Myeloma (POLARIS)” in The Lancet Haematology (2022 impact factor: 30.153).
Shanghai, Oct. 25, 2022 -- Oricell Therapeutics (Shanghai) Co., Ltd. ("Oricell" or "the company”) announced that the United States (U.S) Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation (ODD) to Oricell's proprietary CAR-T cell therapy targeting GPRC5D (OriCar-017) for the treatment of Relapsed/Refractory Multiple Myeloma (R/R MM).
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.
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