Oricell Publishes Data from POLARIS Clinical Study Evaluating OriCAR-017 in the Treatment of RRMM in The Lancet Haematology

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).

The POLARIS study,the first-in-human study of OriCAR-017,explores the safety,tolerability and preliminary anti-tumor efficacy for a single intravenous infusion of OriCAR-017 in patients with RRMM (NCT05016778). As of June 30,2022,the study had showed exciting clinical results for OriCAR-017 in the treatment of 10 patients with RRMM:

Median follow-up time: 238 days (range: 99-345 days)

Safety: Dose-limiting toxicities (DLTs),serious adverse events (SAEs),neurotoxicity and deaths were not observed. The common treatment-emergent AEs were Grade 3 or 4 hematologic toxicities,including neutropenia,leukopenia,thrombocytopenia and anemia. Cytokine release syndrome (CRS) was observed in all patients (9 patients in G1 and one patient in G2).

Preliminary clinical efficacy: the study revealed an impressive 100% overall response rate,with 60% stringent complete response and 40% very good partial response. All patients (100%) achieved MRD negative (10-5/ml). Additionally,of the 5 patients who relapsed after BCMA CAR T-cell therapy,2 achieved stringent complete response and 3 achieved very good partial response. At the date cut-off time,the mPFS (median progression-free survival) has not yet been reached; for the 2 patients who had disease progression,one with GPRC5D-positive while the other one with GPRC5D-negative.

"Advances in the treatment of R/RMM,including the introduction of immunomodulatory drugs,proteasome inhibitors and monoclonal antibodies as well as stem cell transplantation,have prolonged survival in R/RMM patients,the disease remains a clinically incurable plasma cell neoplasm," saidProf. He Huang,Bone Marrow Transplantation Center,The First Affiliated Hospital,School of Medicine,Zhejiang University. "Nevertheless,almost all R/RMM patients eventually experience one or more relapses,with poorer survival outcomes for those with high-risk cytogenetic characteristics or refractory diseases. Data from our study showed that with extraordinary clinical efficacy,OriCAR-017 has been proved to be a novel,safe and effective therapy for patients with R/RMM,especially for those who experienced a relapse after receiving BCMA-targeted therapy. We are looking forward to continuously conducting follow-up clinical studies of OriCAR-017 in concert with Oricell."

"OriCAR-017 has demonstrated 100% ORR and controllable safety in the POLARIS study,providing a solid foundation for Oricell's subsequent registration of clinical studies," stated Helen Yang,Chairman and CEO of Oricell. "The firm is in the process of submitting an application in the US and China for the registration of clinical studies of OriCAR-017 while advancing the therapy to critical phases of clinical research as soon as possible."

About OriCAR-017

OriCAR-017,one of the key therapies developed by Oricell based on the company's two proprietary technology platforms OriAband OriCAR,is a GPRC5D-targeted CAR T-Cell therapy used to treat relapsed/refractory multiple myeloma (RRMM).

In June 2022,Oricell announced data from Phase I POLARIS clinical trial conducted by investigators in Chinaat the American Society of Clinical Oncology (ASCO) annual meeting for 2022. As of April 30,all evaluable dataof the study had showed 100% ORR as well as 100% minimal residual disease (MRD) negative rate as measured by flow cytometry (10-5) at day 28 after infusion in all participators,including those who relapsed following the BCMA CAR-T therapy.

In October 2022,OriCAR-017 received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of RRMM.

Currently,the company is accelerating the registration of the therapy in both China and the US.

About Multiple Myeloma

Multiple myeloma (MM),one of the most common blood cancers,is a malignant disease of abnormal proliferation of clonal plasma cells. For newly treated MM patients,commonly used first-line treatment drugs include proteasome inhibitors,immunomodulatory drugs and alkylating agents. For most patients,the commonly used first-line treatments can stabilize the patient's condition for 3-5 years,but a small number of patients show primary drug resistance at initial treatment,and the disease cannot be effectively controlled. Most of the newly treated patients with effective treatment will inevitably enter the relapse and refractory stage after the stable disease period. Therefore,there is still an unmet clinical need for patients with relapsed/refractory multiple myeloma. In the United States,MM accounts for nearly 2% of all new cancer cases and more than 2% of cancer deaths. (For more information,see https://pubmed.ncbi.nlm.nih.gov/33498356/ )

About Oricell

Oricell Therapeutics was founded in 2015 as an innovative biopharmaceutical company in China. It is committed to developing tumor cellular immunotherapeutics through its own innovative technology platforms. Oricell has applied for 91 invention patents (including 6 PCT),with 10 already granted.

Oricell Therapeutics' mission is to develop affordable drugs for unmet clinical needs worldwide. It has built several proprietary technology platforms based on tumor cell immunotherapy,including Ori®Ab and Ori®CAR. Oricell Therapeutics has broken through several of the bottlenecks facing CAR-T for solid tumors in terms of antibody engineering construction technology,tumor immune microenvironment regulation,T cell infiltration and killing ability. Oricell has presented the clinical research data of its proprietary CAR-T cell therapy targeting GPRC5D (OriCar-017) for the treatment of Relapsed/Refractory Multiple Myeloma (R/R MM) reported in oral presentation at ASCO 2022 annual meeting and the product has received orphan drug designation by US FDA. The company developed the first CAR-T product targeting GPC-3 with positive data from an exploratory clinical study,which was presented at ASCO 2021. Its first independently-developed immune checkpoint (PD-L1/4-1BB) bispecific antibody drug YN051 (ATG101) was licensed to Antengene Corporation (B.6996) for a down payment + milestone of US$142 million for continued development. The program has received approvals in Australia,the U.S. and China for clinical trials,and completed the first patient dosing in Australia and China.

Currently,Oricell Therapeutics has over 10 cellular drug pipelines for solid tumor therapies. Oricell focuses on indications with a wide range of therapeutic needs,including liver,ovarian,gastric,cervical and non-small cell lung cancer,as well as multiple myeloma. With the corporate goal of becoming an innovation-driven global leader in the creation of new tumor immunotherapeutics,Oricell Therapeutics has established an international product development and operations management team,as well as GMP-compliant manufacturing facilities and quality testing and management systems,to continue to explore and develop therapeutically effective,differentiated and affordable drugs through its own innovative technology platforms. The company seeks to create new opportunities for the development of innovative China-made drugs. Oricell has raised over $120 million USD in series B financing this July.

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