SHANGHAI, May 30, 2024 /PRNewswire/ -- JW (Cayman) Therapeutics Co. Ltd (the 'Company' or 'JW Therapeutics', together with its subsidiaries, the 'Group'), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, presented the preliminary clinical data on relmacabtagene autoleucel ('relma-cel') injection in adults with active systemic lupus erythematosus ('SLE') in China at the 2024 European Alliance of Associations for Rheumatology Congress ('EULAR 2024')..

上海，2024年5月30日/PRNewswire/--JW（Cayman）Therapeutics Co.Ltd（“公司”或“JW Therapeutics”，及其子公司，“集团”）是一家专注于开发，制造和商业化细胞免疫治疗产品的独立创新生物技术公司，在2024年欧洲风湿病协会联盟大会（“EULAR 2024”）上，介绍了中国活动性系统性红斑狼疮（SLE）成人注射雷马卡巴他因（relma-cel）的初步临床数据。。

Updates on safety and efficacy of relma-cel in adults with SLE in China (abstract number: 3246; Poster number: POS0054)

relma-cel在中国成人SLE患者中的安全性和有效性更新（摘要编号：3246；海报编号：POS0054）

SLE is a chronic autoimmune disease causing widespread inflammation and tissue damage in the affected organs. There are about one million SLE patients in China, ranking the first worldwide in total numbers and the second in incidence rate. Current conventional therapies include corticosteroids, antimalarial drugs, non-steroidal anti-inflammatory drugs (NSAIDs), cytotoxic drugs and immunosuppressive/modulatory agents.

SLE是一种慢性自身免疫性疾病，在受影响的器官中引起广泛的炎症和组织损伤。中国约有100万SLE患者，总人数居世界第一，发病率居世界第二。目前的常规疗法包括皮质类固醇，抗疟药物，非甾体抗炎药（NSAIDs），细胞毒性药物和免疫抑制剂/调节剂。

However, conventional treatments are poorly tolerated over time, which affects the clinical efficacy, thus leading to poor disease control with organ damage and further affecting prognosis and long-term survival, especially in patients with moderately to severely active SLE who require high doses of corticosteroids and immunosuppressants..

然而，随着时间的推移，常规治疗的耐受性较差，这会影响临床疗效，从而导致疾病控制不佳，器官受损，并进一步影响预后和长期生存，特别是对于需要高剂量皮质类固醇和免疫抑制剂的中度至重度活动性SLE患者。。

This is a single-arm, open-label, multi-center dose escalation study (NCT05765006) in China. Participants will receive an intravenous infusion of CAR-T cells at doses of 25×10^6(25M), 50×10^6(50M), 75×10^6(75M), or 100×10^6(100M), to evaluate the safety and efficacy of relma-cel in SLE patients.

这是一项在中国进行的单臂，开放标签，多中心剂量递增研究（NCT05765006）。参与者将接受25×10 ^ 6（25M），50×10 ^ 6（50M），75×10 ^ 6（75M）或100×10 ^ 6（100M）剂量的CAR-T细胞静脉输注，以评估relma-cel在SLE患者中的安全性和有效性。

As of April 8, 2024, a total of 12 patients enrolled and received the single infusion of relma-cel. Safety, pharmacokinetics and pharmacodynamics ('PK/PD') and efficacy assessments were conducted across low, medium, and high dosage groups, with the longest follow-up duration of more than 9 months. At EULAR 2024, we presented data from patients in the low-dose group with relatively longer follow-up period, up to the data cutoff date of December 18, 2023..

截至2024年4月8日，共有12名患者登记并接受了单次输注relma-cel。在低，中，高剂量组中进行安全性，药代动力学和药效学（“PK/PD”）和疗效评估，最长随访时间超过9个月。在EULAR 2024年，我们提供了低剂量组患者的数据，随访时间相对较长，截至2023年12月18日的数据截止日期。。

Three patients with active SLE received single intravenous infusion of relma-cel at the dose level of 25M and completed at least 4-months follow-up. All the three patients were female with multiorgan involvement and previously exposed to high-dose steroids and several immunosuppressive treatments. Two had a medical history of more than ten years, and two patients received biological agents.

三名活动性SLE患者接受单次静脉输注25M剂量的relma-cel，并完成至少4个月的随访。这三名患者均为女性，多器官受累，之前曾接受过大剂量类固醇和几种免疫抑制治疗。两名患者的病史超过十年，两名患者接受了生物制剂治疗。

After relma-cel administration, clinical signs and symptoms of SLE patients continued to be improved: SELENA-SLEDAI (Systemic Lupus Erythematosus Disease Activity Index) ('SRI-4') score dramatically decreased from 8~14 to 0/1, and all the three patients achieved SRI-4 while two patients reached the more stringent lupus low disease activity status (LLDAS).

服用relma-cel后，SLE患者的临床体征和症状持续改善：SELENA-SLEDAI（系统性红斑狼疮疾病活动指数）（'SRI-4'）评分从8〜14降至0/1，所有三名患者均达到SRI-4，而两名患者达到更严格的狼疮低疾病活动状态（LLDAS）。

As of the data cut-off, all the three patients no longer used corticosteroids nor immunosuppressants. PK/PD data once again confirmed the proliferation of relma-cel in vivo and complete depletion of peripheral blood B cells. In addition, relma-cel demonstrated manageable safety profile. Cytokine release syndrome ('CRS') occurred in two patients (one had Grade 1 and another had Grade 3).

截至数据截止，所有三名患者不再使用皮质类固醇或免疫抑制剂。PK/PD数据再次证实了relma细胞在体内的增殖和外周血B细胞的完全消耗。此外，relma cel表现出可控的安全性。两名患者发生细胞因子释放综合征（CRS）（一名为1级，另一名为3级）。

No neurotoxicity (NT) occurred. Cytopenia occurred in two patients. Infection, macrophage activation syndrome (MAS), and effusion were observed in one single patient. The patients completely recovered around Day 60 with appropriate treatments..

没有发生神经毒性（NT）。两名患者发生血细胞减少症。在一名患者中观察到感染，巨噬细胞活化综合征（MAS）和积液。通过适当的治疗，患者在第60天左右完全康复。。

The above three patients are still under study follow-up. Over the follow-up time exceeding 6-months, all three patients demonstrated ongoing improvements in both disease activity and clinical symptoms. Our preliminary data showed that relma-cel, even at a dosage significantly lower than that of hematological tumors, can effectively induce profound and lasting remissions in patients with moderate to severe SLE, while maintaining a favorable safety profile.

上述三名患者仍在研究随访中。在超过6个月的随访时间内，所有三名患者均表现出疾病活动和临床症状的持续改善。我们的初步数据显示，即使剂量显着低于血液肿瘤，relma-cel也可以有效诱导中重度SLE患者的深度和持久缓解，同时保持良好的安全性。

These encouraging results bolster JW Therapeutics' potentials for further clinical development in SLE and other autoimmune diseases..

这些令人鼓舞的结果增强了JW Therapeutics在SLE和其他自身免疫性疾病中进一步临床开发的潜力。。

Up to date, the investigator-initiated trial ('IIT') is actively ongoing to accumulate data from a larger cohort with longer follow-up periods. To summarize the efficacy data for nine patients at different dose levels (three cases in the 25M dosage group, three cases in the 50M dosage group, and three cases in the 75M dosage group), 100% patients achieved an SRI-4 response at 3-month after relma-cel infusion.

迄今为止，研究者发起的试验（“IIT”）正在积极进行，以积累更大队列的数据，随访时间更长。为了总结9例不同剂量水平患者的疗效数据（25M剂量组3例，50M剂量组3例，75M剂量组3例），100%患者在3个月时达到SRI-4反应。relma-cel输注后。

Notably, for those four patients (three cases from the 25M group and one from the 50M group) followed up for at least six months, still maintained a 100% SRI-4 response rate. Among all patients who received relma-cel infusion (three cases in the 25M group, three cases in the 50M group, and six cases in the 75M group), eleven patients (91.67%) stopped using traditional corticosteroids and immunosuppressants.

值得注意的是，对于这四名患者（25M组三名，50M组一名），随访至少六个月，仍然保持100%的SRI-4缓解率。在所有接受relma-cel输注的患者中（25M组3例，50M组3例，75M组6例），11例（91.67%）停止使用传统皮质类固醇和免疫抑制剂。

This has not only alleviated the medication burden on patients but also minimized potential side effects. Additionally, significant improvements in organ damage have been observed in most patients, with remarkable reductions in SLE disease activity and anti-double-stranded DNA (dsDNA) antibody levels, as well as a notable decrease in the 24-hour urinary protein levels post-infusion.

这不仅减轻了患者的药物负担，而且最大限度地减少了潜在的副作用。此外，在大多数患者中观察到器官损伤的显着改善，SLE疾病活性和抗双链DNA（dsDNA）抗体水平显着降低，输注后24小时尿蛋白水平显着降低。

And 100% patients achieved rapid complete peripheral B-cell depletion after the infusion, with a median time of four days to onset. Across all dosage groups, CAR-T cells rapidly expanded, reaching peak levels around Day 8, and a clear dose-response relationship was observed. Patients in the higher dosage groups exhibited higher peak pharmacokinetic (PK) values, and longer-lasting duration of B-cell depletion..

输注后100%的患者实现了快速完全的外周B细胞耗竭，中位发病时间为四天。在所有剂量组中，CAR-T细胞迅速扩增，在第8天左右达到峰值水平，并且观察到明显的剂量-反应关系。高剂量组的患者表现出更高的峰值药代动力学（PK）值，以及更长的B细胞耗竭持续时间。。

Patients in all dosage groups showed good safety and tolerability, with only one case of Grade 3 CRS and no instances of Grade 3 or above neurotoxicity. Additionally, only two patients experienced Grade 3 infections, and all adverse events resolved following appropriate treatment.

所有剂量组的患者均表现出良好的安全性和耐受性，只有1例3级CRS，没有3级或以上神经毒性的情况。此外，只有两名患者经历了3级感染，所有不良事件均在适当治疗后得到解决。

The preliminary data from this IIT indicated that relma-cel could achieve deep and durable disease remission in patients with moderate to severe SLE, with a favorable safety profile. Based on the available/published clinical trial data, this study stands out among all clinical studies of CAR-T therapy in SLE due to its largest number of patients enrolled and the longest follow-up period, offering us robust efficacy, PK/PD, and safety data.

该IIT的初步数据表明，relma-cel可以在中度至重度SLE患者中实现深度和持久的疾病缓解，具有良好的安全性。根据现有/已发表的临床试验数据，本研究在SLE CAR-T治疗的所有临床研究中脱颖而出，因为它登记的患者数量最多，随访时间最长，为我们提供了强大的疗效，PK/PD和安全性数据。

As the pioneering commercial CAR-T therapy to receive the first Investigational New Drug (IND) approval for SLE treatment, relma-cel shows promising prospects for swift progression to the Biologics License Application (BLA) stage. We anticipate further communications with regulatory authorities to hasten the commercialization of this groundbreaking treatment and offer a transformative therapeutic option to those living with SLE..

作为首家获得SLE治疗研究新药（IND）批准的开创性商业CAR-T疗法，relma cel显示出迅速进入生物制剂许可证申请（BLA）阶段的前景。我们预计将与监管机构进行进一步沟通，以加速这种开创性治疗的商业化，并为SLE患者提供变革性的治疗选择。。

Dr. Mark J. Gilbert, Chief Medical Officer of JW therapeutics, said, 'Despite the recent emergence of novel biologics and therapies for SLE, many SLE patients still do not respond to available treatments, and there is currently no reliable treatment strategy to achieve drug-free remissions or even to cure the disease.

JW therapeutics首席医疗官马克·吉尔伯特（Mark J.Gilbert）博士说，“尽管最近出现了针对SLE的新型生物制剂和疗法，但许多SLE患者仍然对现有的治疗方法没有反应，目前还没有可靠的治疗策略来实现无药缓解甚至治愈疾病。

The short-term follow-up data from this study have preliminarily shown that low-dose relma-cel injection has a favorable safety profile in SLE patients, and is able to bring about deep remission, especially enabling patients to achieve low disease activity or even drug-free remission, which makes its application in the treatment of SLE a promising prospect.'.

本研究的短期随访数据初步表明，低剂量relma-cel注射液在SLE患者中具有良好的安全性，能够带来深度缓解，特别是使患者达到低疾病活动性甚至无药物缓解，这使得其在SLE治疗中的应用前景广阔。

About Relmacabtagene Autoleucel Injection

关于Relmacabtagene Autoleucel注射液

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company).

Being the first product of JW Therapeutics, relma-cel has been approved by the China National Medical Products Administration (NMPA) for two indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBLC) after two or more lines of systemic therapy, and the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), making it the first CAR-T product approved as a Category 1 biologics product in China.

作为JW Therapeutics的首个产品，relma-cel已被中国国家医药管理局（NMPA）批准用于两种适应症，包括治疗两种或两种以上全身治疗后复发或难治性大B细胞淋巴瘤（r/r LBLC）的成年患者，以及治疗难治性滤泡性淋巴瘤或二线或以上全身治疗（r/r FL）24个月内复发的成年患者，使其成为中国首个被批准为1类生物制品的CAR-T产品。

Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations..

目前，它是中国唯一同时被纳入国家重大新药开发计划、优先审查和突破性治疗指定的CAR-T产品。。

About JW Therapeutics

关于JW Therapeutics

JW Therapeutics (Stock Code: 2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, and is committed to becoming an innovation leader in cell immunotherapy. Founded in 2016, JW Therapeutics has built a world-class platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases.

JW Therapeutics（股票代码：2126）是一家独立创新的生物技术公司，专注于开发，制造和商业化细胞免疫疗法产品，并致力于成为细胞免疫疗法的创新领导者。JW Therapeutics成立于2016年，为细胞免疫疗法的产品开发建立了世界一流的平台，并建立了涵盖血液恶性肿瘤，实体瘤和自身免疫性疾病的产品线。

JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and worldwide, and leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com..

JW Therapeutics致力于为中国和世界各地的患者带来突破性和优质的细胞免疫治疗产品以及治愈的希望，并引领中国细胞免疫治疗行业的健康和标准化发展。欲了解更多信息，请访问www.jwtherapeutics.com。。

Forward-Looking Statements

前瞻性声明

The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company.

前瞻性陈述基于管理层的期望和信念，并受到许多风险和不确定性的影响，这些风险和不确定性可能导致实际结果与所描述的结果存在重大差异。重大风险和不确定性，包括以下讨论的风险和不确定性，以及该公司提交的香港交易所（HKEx）报告中更详细描述的风险和不确定性。

Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/..

除非另有说明，本公司自公布之日起提供此信息，并明确表示不承担更新问题和相关信息中包含的信息或提供任何解释的义务。有关详细信息，请访问公司网站：www.jwtherapeutics.com/en/forward-looking-statements/。。

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SOURCE JW Therapeutics

来源JW Therapeutics

Company Codes: HongKong:2126

公司代码：香港：2126