We focus on hematology and oncology indications where cell therapies' benefits are promising and evident among patient
and physician communities around the world
·A GPRC5D targeting autologous CAR-T therapy for relapsed or refractory Multiple Myeloma
·Received FDA IND Approval in December 2023
·Received NMPA IND Approval in Aug 2023
·Received FDA Orphan Drug Designation in Oct 2022
·Follow-up clinical data published on The Lancet Haematology
·Initial clinical results presented at 2022 ASCO and EHA
·A GPC3 targeting autologous CAR-T therapy for advanced hepatocellular carcinoma or HCC
·NMPA IND Approved in Sep 2022
·Initial clinical results presented at 2021 ASCO
Our OriAb platform represents one of the largest and most diversified antibody libraries to screen and optimize antibodies for CAR-T programs. Our OriCAR platform generates CAR constructs that deliver a combination of enhanced infiltration, high memory T cells, anti-exhaustion and anti-tumor activities. On top of these, our solid CMC capabilities put the design to work.
·1011 human naïve phage-display library
·1011 synthetic nanobody library
·High memory T cells ratio
·Enhanced infiltration
·Resistant to exhaustion in TME
·Superior anti-tumor activities
·Led by seasoned CMC experts in cell therapies
·In-depth knowhow for product development and optimization
·Stemness-based innovations in CAR-T production
SHANGHAI, NEW JERSEY - July 15th, 2024 - Oricell Therapeutics, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation (FTD) for OriCAR-017, a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). This designation is expected to accelerate the progress of clinical trials and the New Drug Application (NDA/BLA) review process. Prior to this, the FDA has granted Orphan Drug Designation (ODD) and has cleared an Investigational New Drug Application (IND) for OriCAR-017.
New Jersey, USA, and Shanghai, China — June 5, 2024 — Oricell Therapeutics, a pioneering clinical-stage biopharmaceutical company, has presented the two-year long-term follow-up results of OriCAR-017, an open-label Phase I study evaluating GPRC5D-targeted CAR-T therapy in patients with relapsed/refractory multiple myeloma (RRMM), in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Shanghai, New Jersey - May 24, 2024 - Oricell Therapeutics has announced the full abstract (Abstract ID:7511) detailing the two-year long-term follow-up results of OriCAR-017, an open-label Phase I study evaluating GPRC5D targeting CAR-T therapy in patients with Relapsed/Refractory Multiple Myeloma (POLARIS), is now available on the 2024 American Society of Clinical Oncology (ASCO) official website.
SHANGHAI, NEW JERSEY — May 16th, 2024 — Oricell Therapeutics, a clinical-stage biotechnology company at the forefront of developing innovative therapies for life-threatening diseases, is pleased to announce its participation in the upcoming ASCO 2024 Annual Meeting（31th May-4th June). The Company will deliver an oral presentation and two poster presentations, highlighting updated clinical data from POLARIS study that evaluates OriCAR-017, a GPRC5D targeted CAR-T program, as well as showcasing other novel therapeutic approaches.
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.
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).
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