Anbal-cel argeting DLBCL completes phase 2 trial

Anbal cel靶向DLBCL完成2期试验

Anticipation growing over Korea's first CAR-T therapy ahead of regulatory review

在监管审查之前，对韩国首个CAR-T疗法的预期不断增长

Commercial manufacturing scheduled in 2025 at Korea's only CAR-T GMP facility

商业制造计划于2025年在韩国唯一的CAR-T GMP设施

DAEJEON, South Korea, Nov. 1, 2023 /PRNewswire/ -- Curocell, South Korea based CAR-T specialized company (CEO: Gunsoo Kim), has completed Phase 2 clinical trial for its next-generation CD19 CAR-T therapy 'Anbal-cel' that targets relapsed or refractory DLBCL (Diffuse Large B-cell Lymphoma).

韩国大田，2023年11月1日/PRNewswire/-位于韩国的CAR-T专业公司Curocell（首席执行官：Gunsoo Kim）已完成其下一代CD19 CAR-T治疗的2期临床试验“Anbal-cel”，针对复发或难治性DLBCL（弥漫性大B细胞淋巴瘤）。

This announcement is a significant milestone and is paving the way towards the launch and approval of Korea's first CAR-T therapy. It has also provied typo new hope for the treatment of patients with DLBCL, an aggressive form of cancer that is growing in prevalence within Korea.

本公告是一个重要的里程碑，为韩国首个CAR-T疗法的推出和批准铺平了道路。它还为DLBCL患者的治疗提供了新的希望，DLBCL是一种在韩国流行的侵袭性癌症。

The Phase 2 clinical trial evaluated the safety, efficacy and tolerability of 'Anbal-cel' in patients with relapsed or refractory DLBCL. It was conducted over a period of 20 months starting in February 2022, enrolling a total of 80 patients from six hospitals across Korea, including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, National Cancer Center, Chonnma typo National University Hospital, and Pusan National University Hospital..

2期临床试验评估了复发或难治性DLBCL患者'Anbal-cel'的安全性，有效性和耐受性。这项研究从2022年2月开始，为期20个月，共招收了来自韩国六家医院的80名患者，其中包括三星医疗中心，牙山医疗中心，首尔国立大学医院，国立癌症中心，全马印刷国立大学医院和釜山国立大学医院。。

'Anbal-cel' is a next-generation CAR-T therapy based on Curocell's OVIS™ technology that significantly inhibits the expression of PD-1 and TIGIT, two types of immune checkpoint receptors, which are known to inhibit anti-tumor function/activity of CAR-T cells. This technology has substantially improved the therapeutic performance of CAR-T therapy in patients with relapsed or refractory DLBCL with a poor prognosis..

'Anbal-cel'是基于Curocell's OVIS的下一代CAR-T疗法™ 显着抑制PD-1和TIGIT（已知抑制CAR-T细胞的抗肿瘤功能/活性的两种免疫检查点受体）表达的技术。该技术大大提高了CAR-T治疗复发或难治性DLBCL患者预后不良的治疗效果。。

Curocell made international headlines during the company's oral presentation of its Phase 2 clinical trial interim results at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland back in June. The interim results analyzed the efficacy and safety of its CAR-T treatment in 41 patients participating in the Phase 2 trial.

Curocell在6月份在瑞士卢加诺举行的国际恶性淋巴瘤会议（ICML）上口头介绍其2期临床试验中期结果时，成为国际头条新闻。中期结果分析了其参与2期试验的41名患者的CAR-T治疗的有效性和安全性。

The complete response rate (CRR: Rate at which the cancer enters into full remission) observed in the interim results was 71%, showing an improved therpeutic effect compared to the 40 to 50% CRR range for three FDA-approved CAR-T therapies currently on the market..

在中期结果中观察到的完全缓解率（CRR：癌症进入完全缓解的比率）为71%，与目前FDA批准的三种CAR-T疗法的40%至50%CRR范围相比，显示出改善的治疗效果。市场。。

Curocell plans to officially announce the final results of its Phase 2 clinical trial for 'Anbal-cel' in the first half of next year and submit an BLA application to Korea's Ministry of Food and Drug Safety for approval next September. Starting from the expected year of approval in 2025, the company is planning to launch the supply of commercial products from Korea's only large-scale GMP facility dedicated to the production of CAR-T boasting state-of-the-art equipment..

Curocell计划在明年上半年正式公布其“Anbal-cel”2期临床试验的最终结果，并于9月向韩国食品药品安全部提交BLA申请以获得批准。从2025年批准的预期年份开始，该公司计划从韩国唯一的大型GMP设施开始供应商业产品，该设施致力于生产拥有最先进设备的CAR-T。。

CEO of Curocell, Gunsoo Kim said that, 'I am extremely proud that we were able to complete Korea's first clinical Trial or study for CAR-T therapy in such a short period of time, which I believe is one of the most remarkable achievement in the history of drug development in Korea.' He added, 'We will make every effort to obtain approval for Anbal-cel in 2025 and ensure sustained growth for the company through future expansion in our overseas business.'.

Gunsoo Kim的Curocell首席执行官说：“我非常自豪，我们能够在如此短的时间内完成韩国的第一次临床试验或CAR-T治疗研究，我相信这是最显着的成就之一在韩国的药物开发历史上“他补充说：“我们将尽一切努力在2025年获得Anbal cel的批准，并通过未来扩大海外业务确保公司的持续增长。”。

The clinical trial for 'Anbal-cel' was officially selected by the Korea Drug Development Fund (KDDF) in 2021 as the target of a government grant. It was conducted with the support of the National New Drug Development Project Team, funded by the Ministry of Science, ICT, and Future Planning, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare.

韩国药物开发基金（KDDF）于2021年正式选择“Anbal cel”临床试验作为政府资助的目标。它是在科学，信息通信技术和未来规划部，贸易，工业和能源部以及卫生福利部资助的国家新药开发项目组的支持下进行的。

(Project Number: HN21C0653).

（项目编号：HN21C0653）。

Corporate Overview

公司概况

'Fight Against Hopelessness: Curocell is spearheading the development of innovative cancer immunotherapies'Curocell is Korea's first company specialized in CAR-T treatment, developing CAR-T cell therapies that have become one of the world's most promising new drugs to emerge in recent years. Curocell's technology aims to overcome the limitations of existing cancer immunotherapies to treat a wide variety of different cancer types.

'抗击绝望：Curocell率先开发创新型癌症免疫疗法'Curocell是韩国第一家专门从事CAR-T治疗的公司，开发CAR-T细胞疗法，已成为近年来出现的世界上最有希望的新药之一。Curocell的技术旨在克服现有癌症免疫疗法的局限性，以治疗各种不同的癌症类型。

Curocell is working with top experts in various fields such as CAR-T technology development, biopharmaceutical development, production and GMP, while also collaboaring with major Korean hospitals for the systematic development of new CAR-T cell therapies. Curocell is Korea's first company to obtain regulatory approval to conduct CAR-T clinical trials, and is widely recognized as the country's leading company in the field of CAR-T cell therapy, possessing a large-scale commercial GMP facility with state-of-the-art equipment to manufacture its products..

Curocell与CAR-T技术开发，生物制药开发，生产和GMP等各个领域的顶尖专家合作，同时还与韩国主要医院合作，系统开发新的CAR-T细胞疗法。Curocell是韩国第一家获得CAR-T临床试验监管批准的公司，被广泛认可为该国CAR-T细胞治疗领域的领先公司，拥有大规模商业GMP设施和最先进的设备来制造其产品。。

'CAR-T cell therapy, a next generation cancer immunotherapy'CAR-T (Chimeric Antigen Receptor-T) cell therapy is a next generation cancer immunotherapy that involves genetically modifying a patient's immune T cells in vitro to express antigens that specifically target cancer cells, then reintroducing them into the patient to destroy the cancer.

CAR-T细胞疗法是下一代癌症免疫疗法CAR-T（嵌合抗原受体-T）细胞疗法是下一代癌症免疫疗法，其涉及在体外遗传修饰患者的免疫T细胞以表达特异性靶向癌细胞的抗原，然后将它们重新引入患者体内以摧毁癌症。

Through the process of separating the patient's immune cells, modifying their genes, and cultivating them en masse, it is possible to achieve complete remission in a terminal leukemia patient with just a single administration where no other treatment options are available..

通过分离患者的免疫细胞，修饰其基因并大量培养它们的过程，只需一次给药就可以在没有其他治疗选择的情况下，在终末期白血病患者中实现完全缓解。。

SOURCE Crucocell Inc.

来源Crucocell股份有限公司。