Smart Immune treats adult acute leukemia patient at final dose level in Phase I/II ReSET-02 trial

智能免疫在I/II期ReSET-02试验中以最终剂量水平治疗成人急性白血病患者

PARIS, France, May 2, 2024 – Smart Immune, a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T cell progenitor therapy platform to rapidly re-arm the immune system against cancers and infections, today announces the treatment of the first patient in the third and final dose cohort of the dose-escalation stage in its ReSET-02 trial.

2024年5月2日，法国巴黎–Smart Immune是一家临床阶段生物技术公司，开发ProTcell，一种胸腺增强的T细胞祖细胞治疗平台，可快速重新武装免疫系统对抗癌症和感染，今天宣布在ReSET-02试验中，治疗剂量递增阶段第三个也是最后一个剂量队列中的第一名患者。

This is an important milestone in the evaluation of SMART101 in post-transplant hematology..

这是SMART101在移植后血液学评估中的一个重要里程碑。。

The ReSET-02 trial (NCT05768035) is a Phase I/II multi-center, open-label, dose-escalation study to assess the safety and efficacy of Smart Immune’s lead asset, SMART101, an allogeneic T cell progenitor therapy, after allogeneic HSCT with post-transplant cyclophosphamide (PTCy), in adult patients with acute lymphoid leukemia.

ReSET-02试验（NCT05768035）是一项I/II期多中心，开放标签，剂量递增研究，用于评估Smart Immune的领先资产SMART101（一种同种异体T细胞祖细胞疗法）在同种异体HSCT与移植后环磷酰胺（PTCy）治疗成人急性淋巴细胞白血病患者后的安全性和有效性。

The trial has progressed to the final dose (9.0 x 106 CD7+ cells per kg of body weight) cohort after favorable safety profiles observed in patients treated with the first and second dose levels. The product candidate is designed to accelerate T cell reconstitution to fight relapse and infection and improve overall and disease-free survival post-transplant..

在用第一和第二剂量水平治疗的患者中观察到良好的安全性后，该试验已进展至最终剂量（每公斤体重9.0×106个CD7+细胞）队列。候选产品旨在加速T细胞重建，以抵抗复发和感染，并提高移植后的总体和无病生存率。。

Karine Rossignol, CEO and Co-founder, Smart Immune said: “We are thrilled to achieve this key milestone in our ReSET-02 trial after observing an excellent tolerability and safety profile with no dose limiting toxicities or safety issues with the first two dose levels. Reaching the final dose brings us a step closer in our efforts to quickly reset the immune system with a new fit T cell compartment, improving clinical outcomes in patients with high-risk cancers.

Smart Immune首席执行官兼联合创始人卡琳·罗西诺（Karine Rossignol）表示：“我们很高兴在ReSET-02试验中实现这一关键里程碑，因为在前两个剂量水平上，我们观察到了良好的耐受性和安全性，没有剂量限制性毒性或安全问题。达到最终剂量使我们在用新的fit T细胞区室快速重置免疫系统的努力中迈出了一步，从而改善了高危癌症患者的临床结果。

Encouragingly, all preliminary immune reconstitution data, even in patients aged 50-70 years, point in the right direction.” .

令人鼓舞的是，即使在50-70岁的患者中，所有初步的免疫重建数据都指向了正确的方向。”。

No related safety events have been reported to date in the ReSET-02 trial. This encouraging safety profile is further confirmed by the other Smart Immune-sponsored trial data in Europe and the US.

在ReSET-02试验中，迄今为止尚未报告相关的安全事件。欧洲和美国的其他Smart免疫赞助试验数据进一步证实了这一令人鼓舞的安全性。

SMART101 is an allogeneic cell therapy produced from healthy donor mobilized peripheral blood stem cells (CD34+) differentiated into T cell progenitors. It has been granted Orphan Drug Designation (ODD) by the European Medicines Agency and the US Food and Drug Administration (FDA), in addition to Fast Track Designation by the FDA, as a treatment to enhance clinical outcomes in patients receiving allo-HSCT..

SMART101是由分化为T细胞祖细胞的健康供体动员的外周血干细胞（CD34+）产生的同种异体细胞疗法。它已被欧洲药品管理局（European Medicines Agency）和美国食品和药物管理局（FDA）授予孤儿药指定（ODD），此外还被FDA快速指定为一种治疗方法，以提高接受异基因造血干细胞移植（allo-HSCT）的患者的临床疗效。。

About Smart Immune

关于智能免疫

Smart Immune is a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T cell progenitor platform to rapidly re-arm the immune system against cancer and infection. The company aims to radically improve outcomes for patients in hematology and immuno-oncology. SMART101 is in Phase I/II trials for patients with acute leukemia or severe combined immunodeficiencies (SCID), in the EU and the US.

Smart Immune是一家临床阶段的生物技术公司，开发ProTcell，这是一种胸腺增强的T细胞祖细胞平台，可快速重新武装免疫系统以抵抗癌症和感染。该公司旨在从根本上改善血液学和免疫肿瘤学患者的预后。SMART101正在欧盟和美国进行针对急性白血病或严重联合免疫缺陷（SCID）患者的I/II期试验。

Additional clinical applications are planned to be evaluated in combination with innovative cancer therapies..

计划结合创新的癌症疗法对其他临床应用进行评估。。

https://www.smart-immune.com/

https://www.smart-immune.com/

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About the ReSET-02 clinical trial

关于ReSET-02临床试验

SMART101 is being evaluated in the ReSET-02 Phase I/II multi-center, open-label, dose-escalation study (1.5 x 106 CD7+ cells per kg of body weight, 4.5 x 106 CD7+ cells and 9.0 x 106 CD7+ cells per kg of body weight) to evaluate the safety and activity of SMART101 after haploidentical peripheral blood stem cell transplantation with post-transplant cyclophosphamide, in patients with hematological malignancies.

SMART101正在ReSET-02 I/II期多中心开放标签剂量递增研究中进行评估（每公斤体重1.5×106个CD7+细胞，每公斤体重4.5×106个CD7+细胞和9.0×106个CD7+细胞），以评估移植后环磷酰胺单倍体相合外周血干细胞移植后SMART101在血液系统恶性肿瘤患者中的安全性和活性。

In the Phase II segment, patients are being enrolled in parallel into two cohorts according to the intensity of the conditioning chemotherapy and in two consecutive stages according to a Simon’s 2-stage design. The trial is currently conducted at multiple sites in France and Italy. For more information, visit www.clinicaltrials.gov, study identifier number NCT05768035..

在第二阶段，根据调理化疗的强度，患者被平行纳入两个队列，并根据西蒙的两阶段设计分为两个连续阶段。该试验目前在法国和意大利的多个地点进行。有关更多信息，请访问www.clinicaltrials.gov，研究标识符编号NCT05768035。。

About SMART101

关于SMART101

SMART101 is generated ex vivo in 7 days from allogeneic blood stem cells, using Smart Immune’s ProTcell T cell therapy platform. Once injected into the patient, the SMART101 human T cell progenitors travel to the thymus where they are educated to become fully functional and self-tolerant T cells. Preclinical data suggest that the ProTcell platform could reconstitute the immune system in 100 days instead of the 12 to 18 months observed in physiology, thereby protecting patients from infection and relapse..

SMART101使用Smart Immune的ProTcell T细胞治疗平台，在7天内从同种异体造血干细胞离体生成。一旦注射到患者体内，SMART101人类T细胞祖细胞就会进入胸腺，在那里它们会被教育成为功能齐全且具有自我耐受性的T细胞。临床前数据表明，ProTcell平台可以在100天内重建免疫系统，而不是在生理学上观察到的12至18个月，从而保护患者免受感染和复发。。

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媒体联系人：

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