Jasper Therapeutics宣布首个患者接受Briquilimab治疗慢性诱导性荨麻疹的1b/2a期聚光灯临床研究-动脉网

Jasper Therapeutics Announces First Patient Dosed in Phase 1b/2a SPOTLIGHT Clinical Study of Briquilimab in Chronic Inducible Urticaria

BioSpace 等信源发布 2024-03-19 22:34

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REDWOOD CITY, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper’s Phase 1b/2a (SPOTLIGHT) clinical study of subcutaneous briquilimab for the treatment of CIndU.

加利福尼亚州红木市，2024年3月19日（环球通讯社）--Jasper Therapeutics，Inc.（纳斯达克：JSPR）（Jasper），一家生物技术公司，专注于开发briquilimab，一种针对肥大细胞驱动的疾病（如慢性自发性荨麻疹（CSU）和慢性诱导性荨麻疹（CIndU））中c-Kit（CD117）的新型抗体疗法，今天宣布，第一名患者已在Jasper的皮下briquilimab治疗CIndU的1b/2a期（聚光灯）临床研究中服用。

The SPOTLIGHT study is evaluating a single administration, at two different dose levels, of subcutaneous briquilimab in adult patients with cold urticaria (ColdU) or symptomatic dermographism (SD)..

SPOTLIGHT研究正在评估两种不同剂量水平的皮下注射briquilimab治疗成人冷荨麻疹（ColdU）或症状性皮肤病（SD）患者。。

“We are excited to announce dosing of the first patient in the SPOTLIGHT study in patients with CIndU, our second clinical program evaluating briquilimab in a mast cell-mediated disease,” said Edwin Tucker, Chief Medical Officer of Jasper. “As with our BEACON study in CSU, we expect the SPOTLIGHT study to establish proof of concept for the depletion of mast cells by briquilimab in CIndU and help us to determine doses and dosing regimens for future registrational studies.

Jasper首席医疗官埃德温·塔克（EdwinTucker）说：“我们很高兴宣布聚光灯研究中第一位CIndU患者的剂量，这是我们评估briquilimab治疗肥大细胞介导疾病的第二个临床项目。”。“与我们在CSU进行的BEACON研究一样，我们希望SPOTLIGHT研究能够为briquilimab在CIndU消耗肥大细胞建立概念证明，并帮助我们确定未来注册研究的剂量和给药方案。

We plan to provide enrollment updates as we progress through the study and anticipate reporting preliminary data in the second half of 2024.”.

随着研究的进展，我们计划提供入学更新，并预计在2024年下半年报告初步数据。”。

The SPOTLIGHT study is expected to enroll approximately 15 patients across 2 dose cohorts. The primary endpoints are safety and tolerability of briquilimab with secondary endpoints focused on efficacy measures and pharmacokinetics. The study is being conducted at four sites in the EU. Jasper anticipates reporting preliminary data from the SPOTLIGHT study in the second half of 2024..

SPOTLIGHT研究预计将在2个剂量组中招募大约15名患者。主要终点是briquilimab的安全性和耐受性，次要终点集中在疗效测量和药代动力学上。这项研究正在欧盟的四个地点进行。贾斯珀预计将在2024年下半年报告聚光灯研究的初步数据。。

“c-Kit inhibitors are a promising class of monoclonal therapeutics with demonstrated efficacy in mast cell driven diseases,” said Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin. “As a potent and differentiated c-Kit inhibitor, I believe briquilimab has the potential to serve as an important treatment option for patients suffering from CIndU, and I look forward to enrolling patients into the SPOTLIGHT study and additionally into the BEACON study for CSU.”.

柏林Charité–Universitätsmedizin皮肤病学和过敏学教授Marcus Maurer医学博士说：“c-Kit抑制剂是一类很有前途的单克隆疗法，在肥大细胞驱动的疾病中具有明显的疗效。”。“作为一种有效且分化的c-Kit抑制剂，我相信briquilimab有可能成为CIndU患者的重要治疗选择，我期待着将患者纳入聚光灯研究，并加入CSU的BEACON研究。”。

About Briquilimab

关于Briquilimab

Briquilimab (formerly JSP191) is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor c-Kit, also known as CD117, thereby inhibiting signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via apoptosis which removes the underlying source of the inflammatory response in mast cell driven diseases such as chronic urticaria.

Briquilimab（以前称为JSP191）是一种靶向的非糖基化单克隆抗体，可阻断干细胞因子与细胞表面受体c-Kit（也称为CD117）的结合，从而抑制通过受体的信号传导。这种抑制作用破坏了关键的生存信号，导致肥大细胞通过细胞凋亡而耗尽，从而消除了肥大细胞驱动的疾病（如慢性荨麻疹）中炎症反应的潜在来源。

Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU or with CIndU. Briquilimab is also currently in clinical studies as a treatment for patients with LR-MDS and as a conditioning agent for cell therapies for rare diseases. To date, briquilimab has a demonstrated efficacy and safety profile in more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in severe combined immunodeficiency (SCID), AML, MDS, FA, and sickle cell disease (SCD)..

Jasper目前正在进行briquilimab作为CSU或CIndU患者治疗的临床研究。Briquilimab目前也在临床研究中，用于治疗LR-MDS患者，并作为罕见疾病细胞疗法的调理剂。迄今为止，briquilimab在超过145名服用剂量的参与者和健康志愿者中显示出有效性和安全性，临床结果可作为严重联合免疫缺陷（SCID），AML，MDS，FA和镰状细胞病（SCD）的调理剂。。

About Jasper

关于Jasper

Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic urticaria and lower to intermediate risk MDS and as a conditioning agent for stem cell transplants for rare diseases such as SCD, FA and SCID.

Jasper是一家临床阶段生物技术公司，开发briquilimab，一种靶向c-Kit（CD117）的单克隆抗体，用于治疗慢性肥大和干细胞疾病，如慢性荨麻疹和中低风险MDS，并作为干细胞移植的调理剂，用于罕见疾病，如SCD，FA和SCID。

To date, briquilimab has a demonstrated efficacy and safety profile in more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in SCID, AML, MDS, FA, and SCD. For more information, please visit us at www.jaspertherapeutics.com..

迄今为止，briquilimab在超过145名服用剂量的参与者和健康志愿者中具有良好的疗效和安全性，临床结果可作为SCID，AML，MDS，FA和SCD的调理剂。欲了解更多信息，请访问www.jaspertherapeutics.com。。

Forward-Looking Statements

前瞻性声明

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters.

根据1995年《美国私人证券诉讼改革法案》的安全港条款，本新闻稿中包含的某些非历史事实的声明是前瞻性声明。前瞻性陈述有时会伴有“相信”、“可能”、“会”、“估计”、“继续”、“预期”、“打算”、“预期”、“应该”、“会”、“计划”、“预测”、“潜力”、“看起来”、“寻求”、“未来”、“展望”等词以及预测或指示未来事件或趋势或不是历史事件陈述的类似表达。

These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, including with respect to its potential in mast cell driven diseases such as CSU and CIndU and its potential to serve as an important treatment option for patients suffering from CIndU; Jasper’s expectations regarding its Phase 1b/2a SPOTLIGHT study of subcutaneous briquilimab in CIndU, including the expected enrollment, cohorts and site locations, the expected timing for reporting preliminary data, the expectation that the SPOTLIGHT or BEACON studies will establish proof of concept or help Jasper determine doses and dosing regimens for future registrational studies; and Jasper’s expectations regarding its BEACON study in CSU, including the expectation that Jasper will enroll additional patients in the BEACON study for CSU.

这些前瞻性陈述包括但不限于关于briquilimab潜力的陈述，包括其在肥大细胞驱动的疾病（如CSU和CIndU）中的潜力及其作为CIndU患者重要治疗选择的潜力；Jasper对其在CIndU进行的皮下briquilimab 1b/2a期聚光灯研究的期望，包括预期的入学人数，队列和地点，报告初步数据的预期时间，聚光灯或信标研究将建立概念证明的期望或帮助Jasper确定未来注册研究的剂量和给药方案；以及Jasper对其在CSU的BEACON研究的期望，包括Jasper将在CSU的BEACON研究中招募更多患者的期望。

These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an a.

这些声明基于各种假设，无论是否在本新闻稿中确定，以及Jasper目前的期望，而不是对实际表现的预测。这些前瞻性声明仅用于说明目的，不打算作为担保，投资者也不得将其视为担保。

Contacts:

联系人：

Joyce Allaire (investors)

Joyce Allaire（投资者）

LifeSci Advisors

LifeSci顾问

617-435-6602

jallaire@lifesciadvisors.com

Alex Gray (investors)

亚历克斯·格雷（投资者）

Jasper Therapeutics