Gracell is pioneering use of a CD19/BCMA dual-targeted CAR-T cell therapy in refractory systemic lupus erythematosus, aiming for deeper and wider depletion of disease-causing antibody secreting cells and B-cells

Gracell在难治性系统性红斑狼疮中开创性地使用CD19/BCMA双靶向CAR-T细胞疗法，旨在更深和更广泛地消耗致病性抗体分泌细胞和B细胞

FasTCAR-T GC012F has demonstrated deep responses and a favorable safety profile in clinical investigator-initiated trials (IIT) in 60 patients with multiple myeloma and B-cell non-Hodgkin lymphoma (B-NHL)

FasTCAR-tgc012f在60例多发性骨髓瘤和B细胞非霍奇金淋巴瘤（B-NHL）患者的临床研究者启动的试验（IIT）中显示了深刻的反应和良好的安全性

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the U.S.

2023年11月27日（GLOBE NEWSWIRE）-Gracell Biotechnologies Inc.（“Gracell”或“Company”，纳斯达克股票代码：GRCL），一家全球临床阶段生物制药公司致力于开发用于治疗癌症和自身免疫性疾病的创新和高效细胞疗法，今天宣布美国。

Food and Drug Administration (FDA) has cleared Gracell’s Investigational New Drug (IND) application, allowing the Company to initiate a Phase 1/2 clinical trial of FasTCAR-T GC012F in the United States for the treatment of refractory systemic lupus erythematosus (rSLE)..

美国食品和药物管理局（FDA）已批准Gracell的研究性新药（IND）申请，允许该公司在美国启动FasTCAR-T GC012F的1/2期临床试验，用于治疗难治性系统性红斑狼疮（rSLE）。。

“We are excited to expand the clinical development of our lead FasTCAR asset, GC012F, for treatment of rSLE in the United States,” said Dr. William Cao, founder, Chairman and Chief Executive Officer of Gracell. “This progress marks the second U.S. IND clearance for GC012F, a notable milestone. As a next-generation CAR-T therapy, GC012F combines the innovative CD19/BCMA dual-targeting approach and our breakthrough FasTCAR next-day manufacturing technology, both of which could potentially provide meaningful benefits to SLE patients.

Gracell总裁兼首席执行官William Cao博士说：“我们很高兴扩大我们领先的FasTCAR资产GC012F在美国治疗rSLE的临床开发。”。“这一进展标志着GC012F的第二次美国IND清除，这是一个值得注意的里程碑。作为下一代CAR-T疗法，GC012F结合了创新的CD19/BCMA双靶向方法和我们突破性的FasTCAR次日制造技术，两者都有可能为SLE患者提供有意义的益处。

Additionally, what sets GC012F apart is its consistently favorable safety profile demonstrated by the absence of neurotoxicity in 60 patients treated across three IIT studies. We look forward to developing GC012F as a transformative therapy for SLE patients, who are in urgent need of highly effective and safe treatment options.”.

此外，使GC012F与众不同的是其在三项IIT研究中治疗的60名患者中没有神经毒性证明其始终有利的安全性。我们期待开发GC012F作为SLE患者的变革性治疗，他们迫切需要高效和安全的治疗方案。

GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19 and utilizes Gracell’s proprietary FasTCAR next-day manufacturing platform. In addition to the upcoming rSLE IND study, GC012F is being evaluated in the Phase 1b/2 IND study for the treatment of relapsed/refractory multiple myeloma (RRMM) in the U.S., and in four IIT studies for the treatment of rSLE, RRMM, newly-diagnosed multiple myeloma (NDMM) and B-NHL.

GC012F是一种自体CAR-T治疗候选双靶向B细胞成熟抗原（BCMA）和CD19，利用Gracell专有的FasTCAR次日制造平台。除了即将进行的rSLE IND研究外，GC012F正在美国进行1b/2期IND研究，用于治疗复发/难治性多发性骨髓瘤（RRMM），以及四项IIT研究，用于治疗rSLE，RRMM，新诊断的多发性骨髓瘤（NDMM）和B-NHL。

Updated clinical results from the NDMM IIT, which will be presented at the 65ᵗʰ American Society of Hematology Annual Meeting & Exposition in December 2023, demonstrates an overall response rate (ORR) of 100% and minimal residual disease negative stringent complete response (MRD- sCR) rate of 95.5%..

最新的临床结果从NDMM IIT，这将在65ᵗʰAmerican Society of Hematology Annual Meeting＆Exposition于2023年12月展示，总体反应率（ORR）为100%，最小残留病阴性严格完全反应（MRD-sCR）率为95.5%。。

The Phase 1 portion of the Phase 1/2 clinical trial evaluating GC012F in rSLE will be initiated in 2024 and is designed to assess the safety and tolerability of GC012F, determine the recommended dose for Phase 2 study and characterize the pharmacokinetics of GC012F in this patient population.

评估rSLE中GC012F的1/2期临床试验的1期部分将于2024年启动，旨在评估GC012F的安全性和耐受性，确定2期研究的推荐剂量并表征GC012F在该患者中的药代动力学人口。

Systemic lupus erythematosus (SLE) is a B-cell-mediated autoimmune disease, in which autoantibodies produced by the immune system attack the patient’s own tissues, causing multi-organ damage. While immunosuppressants are used as the current standard of care, SLE remains a chronic condition that is difficult to manage, significantly impacts quality of life, and has no cure.

系统性红斑狼疮（SLE）是一种B细胞介导的自身免疫性疾病，其中免疫系统产生的自身抗体攻击患者自身组织，引起多器官损伤。虽然免疫抑制剂被用作当前的护理标准，但SLE仍然是一种难以控制的慢性病，显着影响生活质量并且无法治愈。

There is an urgent, high unmet medical need for more effective – and even curative – therapies, particularly to help manage rSLE..

迫切，高度未满足的医疗需求，需要更有效甚至治愈的疗法，尤其是帮助管理rSLE。。

Several patient case studies in academia have shown CD19 CAR-T cell therapy to be feasible, tolerable and highly effective in a number of autoimmune diseases, including SLE. By targeting both CD19 and BCMA, it is believed that GC012F could enable deeper and wider depletion of disease-causing B-cells and plasma cells, potentially offering a more effective and longer-lasting therapeutic approach for rSLE.

学术界的一些患者案例研究表明，CD19 CAR-T细胞疗法在包括SLE在内的许多自身免疫性疾病中是可行的，可耐受的和高效的。通过靶向CD19和BCMA，相信GC012F可以使致病B细胞和浆细胞更深入和更广泛地消耗，可能为rSLE提供更有效和更持久的治疗方法。

Further, in preclinical studies, GC012F has shown a more effective elimination of antibody secreting cells compared to CD19 single-targeted CAR-T therapy..

此外，在临床前研究中，与CD19单靶向CAR-T疗法相比，GC012F显示出更有效地消除抗体分泌细胞。。

About GC012F

关于GC012F

GC012F is Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer and autoimmune disease treatment by driving fast, deep and durable responses with an improved safety profile. GC012F is currently being evaluated in clinical studies in multiple hematological cancers as well as autoimmune diseases and has demonstrated a consistently strong efficacy and safety profile.

GC012F是Gracell推出的支持FasTCAR的BCMA/CD19双靶向自体CAR-T细胞疗法，旨在通过推动快速，深入和持久的反应以及改进的安全性来改变癌症和自身免疫性疾病治疗。GC012F目前正在多种血液学癌症以及自身免疫性疾病的临床研究中进行评估，并已证明其始终如一的强大功效和安全性。

Gracell has initiated a Phase 1b/2 trial evaluating GC012F for the treatment of RRMM in the United States and a Phase 1/2 clinical trial in China is to be commenced imminently. An IIT has also been launched to evaluate GC012F for the treatment of rSLE and the IND application to study GC012F in rSLE has been cleared by the U.S.

Gracell已启动一项评估GC012F在美国治疗RRMM的1b/2期试验，中国的1/2期临床试验即将开始。还推出了IIT来评估用于治疗rSLE的GC012F，并且美国已经批准了在rSLE中研究GC012F的IND申请。

FDA..

FDA。。

About FasTCAR

FasTCAR

Introduced in 2017, FasTCAR is Gracell’s revolutionary next-day autologous CAR-T cell manufacturing platform. FasTCAR is designed to lead the next generation of therapy for cancer and autoimmune diseases, and improve outcomes for patients by enhancing effect, reducing costs, and enabling more patients to access critical CAR-T treatment.

FasTCAR于2017年推出，第二天是Gracell革命性的自体CAR-T细胞制造平台。FasTCAR旨在引领下一代癌症和自身免疫性疾病治疗，并通过提高疗效，降低成本和使更多患者获得关键的CAR-T治疗来改善患者的预后。

FasTCAR drastically shortens cell production from weeks to overnight, potentially reducing patient wait times and probability for their disease to progress. Furthermore, FasTCAR T-cells appear younger than traditional CAR-T cells, making them more proliferative and effective at killing cancer cells.

FasTCAR将细胞产量从数周大幅缩短至过夜，可能会减少患者的等待时间和疾病进展的可能性。此外，FasTCAR T细胞看起来比传统的CAR-T细胞更年轻，使其更具增殖性并有效杀死癌细胞。

In 2022 and 2023, FasTCAR was named the winner of the Biotech Innovation category of the 2022 Fierce Life Sciences Innovation Awards and the Overall Immunology Solution of 2023 by BioTech Breakthrough Awards, for its ability to address major industry obstacles..

2022年和2023年，FasTCAR因其解决重大行业障碍的能力而被评为2022年激烈生命科学创新奖生物技术创新类别和2023年生物技术突破奖整体免疫学解决方案的获奖者。。

About Gracell

关于Gracell

Gracell Biotechnologies Inc. (“Gracell”) is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies for the treatment of cancers and autoimmune diseases. Leveraging its innovative FasTCAR and TruUCAR technology platforms and SMART CART™ technology module, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost, and lack of effective CAR-T therapies for solid tumors and autoimmune diseases.

Gracell Biotechnologies Inc.（“Gracell”）是一家全球临床阶段生物制药公司，致力于发现和开发用于治疗癌症和自身免疫性疾病的突破性细胞疗法。利用其创新的FasTCAR和TruUCAR技术平台以及智能车™ 技术模块，Gracell正在开发多种自体和同种异体候选产品的丰富临床阶段管道，有可能克服传统CAR-T疗法持续存在的主要行业挑战，包括制造时间长，细胞质量欠佳，治疗成本高，以及缺乏有效的CAR-T治疗实体瘤和自身免疫性疾病。

The lead candidate BCMA/CD19 dual-targeting FasTCAR-T GC012F is currently being evaluated in clinical studies for the treatment of multiple myeloma, B-NHL and SLE. For more information on Gracell, please visit www.gracellbio.com. Follow @GracellBio on LinkedIn..

主要候选BCMA/CD19双靶向FasTCAR-T GC012F目前正在临床研究中用于治疗多发性骨髓瘤，B-NHL和SLE。有关Gracell的更多信息，请访问LinkedIn上的www.gracellbio.com.Follow@gracellbio。。

Cautionary Noted Regarding Forward-Looking Statements

警惕注意有关前瞻性陈述

Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “look forward to,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

本新闻稿中有关未来期望，计划和前景的陈述，以及有关非历史事实事项的任何其他陈述，可能构成1995年“私人证券诉讼改革法”含义内的“前瞻性陈述”。“预期”，“期待”，“相信”，“继续”，“可以”，“估计”，“期望”，“意图”，“可能”，“计划”，“潜力”，“预测”，“项目”，“应该”，“目标”，“将会”等词语旨在确定前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled “Risk Factors” in Gracell’s most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in Gracell’s subsequent filings with the U.S.

由于各种重要因素，实际结果可能与这些前瞻性陈述所表明的结果有很大不同，包括Gracell最近关于20-F表格的年度报告中题为“风险因素”一节中讨论的因素，以及讨论Gracell随后向美国提交申请时的潜在风险，不确定性和其他重要因素。

Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof. Gracell specifically disclaims any obligation to update any forward-looking statement, whether due to new information, future events, or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date. .

证券交易委员会。本新闻稿中包含的任何前瞻性声明仅在本声明发布之日起发言。Gracell明确拒绝更新任何前瞻性声明的义务，无论是由于新信息，未来事件还是其他原因。读者不应在本页上的信息作为其发布日期后的最新或准确信息。 .

Media Contacts

媒体联系人

Marvin Tang

唐

marvin.tang@gracellbio.com

marvin.tang@gracellbio.com

Jessica Laub

杰西卡·劳布

jessica.laub@westwicke.com

jessica.laub@westwicke.com

Investor Contacts

投资者联系

Gracie Tong

唐

gracie.tong@gracellbio.com

gracie.tong@gracellbio.com

Stephanie Carrington

斯蒂芬妮·卡林顿

stephanie.carrington@westwicke.com

stephanie.carrington@westwicke.com