MoonLake Immunotherapeutics has received FDA Fast Track designation for the treatment of palmoplantar pustulosis with its novel IL-17 inhibitor, speeding up drug development. Meanwhile, Alys Pharmaceuticals and iOnctura both published high-impact papers confirming the potential of their lead assets..

MoonLake Immunotherapeutics公司已获得FDA快速通道资格，用于其新型IL-17抑制剂治疗掌跖脓疱病，加速了药物开发。同时，Alys Pharmaceuticals和iOnctura均发表了高影响力论文，证实了各自核心资产的潜力。

MoonLake Immunotherapeutics

月湖免疫治疗公司

, a clinical-stage biopharmaceutical company focused on developing advanced therapies for inflammatory diseases, announced that its lead asset, sonelokimab, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe palmoplantar pustulosis (PPP), a chronic inflammatory skin disease.

，一家专注于开发炎症性疾病先进疗法的临床阶段生物制药公司，宣布其主要资产 sonelokimab 已获得美国食品药品监督管理局（FDA）快速通道资格，用于治疗中度至重度掌跖脓疱病（PPP），一种慢性炎症性皮肤病。

The designation was granted following positive results from the Phase 2 LEDA trial. FDA Fast Track is intended to facilitate the development and expedite the review of new therapies for serious conditions where there is an unmet medical need..

该指定是在第二阶段LEDA试验取得积极结果后授予的。FDA快速通道旨在促进严重疾病新疗法的开发，并加速对未满足医疗需求的疗法的审查。

Sonelokimab (M1095) is an investigational 40 kDa humanized Nanobody® consisting of three heavy-chain-only antibodies covalently linked by flexible glycine-serine spacers, able to inhibit interleukin-17 (IL-17), a major inflammatory driver. Nanobodies® represent a new generation of antibody-derived targeted therapies.

Sonelokimab（M1095）是一种研究中的40 kDa人源化纳米抗体®，由三个仅含重链的抗体通过柔性的甘氨酸-丝氨酸间隔区共价连接而成，能够抑制白细胞介素-17（IL-17），这是一种主要的炎症驱动因子。纳米抗体®代表了新一代的抗体衍生靶向疗法。

They have several advantages over traditional antibodies, including their small size, enhanced tissue penetration, resistance to temperature changes, ease of manufacturing, and their ability to be designed into multivalent therapeutic molecules with bespoke target combinations..

它们相比传统抗体有几个优势，包括体积小、组织穿透力强、抗温度变化、易于制造，以及能够被设计成具有定制靶点组合的多价治疗分子。

Two high-impact papers published

两篇高影响力的论文发表

Alys Pharmaceuticals

艾丽斯制药公司

, which is focused on immuno-dermatology, has announced a recent publication in

，该公司专注于免疫皮肤病学，宣布了最近在某个刊物上的发表。

Nature Communications

自然通讯

featuring encouraging data from their lead asset ALY-101, a small interfering RNA (siRNA)-lipid conjugate. The paper demonstrates that the siRNA remains durable in the skin for over two months, highlighting its strong therapeutic potential. ALY-101 is currently in Phase 2a clinical trials for the treatment of patchy alopecia areata, a chronic autoimmune disease that causes hair to fall out..

主打产品ALY-101（一种小干扰RNA（siRNA）-脂质结合物）的鼓舞人心的数据。本文展示了该siRNA在皮肤中能持续两个月以上，突显了其强大的治疗潜力。ALY-101目前正处于治疗斑块型斑秃的2a期临床试验阶段，斑秃是一种导致脱发的慢性自身免疫性疾病。

Dedicated to combating neglected and hard-to-treat cancers,

致力于对抗被忽视和难以治疗的癌症，

iOnctura

离子肿瘤学

is developing new treatments with precision oral small molecules that target cancers in novel ways. The company recently published encouraging results on their lead asset roginolisib, a novel allosteric modulator of PI3Kδ in

正在开发以精确口腔小分子治疗癌症的新方法。该公司最近发布了其主要资产 roginolisib（一种新型的 PI3Kδ 别构调节剂）的鼓舞人心的结果。

Molecular Oncology

分子肿瘤学

. The paper provides an in‑depth look at the unique biology and differentiated mechanism of roginolisib, reinforcing its potential to deliver meaningful anti‑tumor activity without the immune‑related toxicities traditionally associated with PI3Kδ inhibition.

本文深入探讨了roginolisib的独特生物学特性及其差异化作用机制，进一步证实其在不产生与PI3Kδ抑制相关的免疫毒性的情况下，具有显著抗肿瘤活性的潜力。

Roginolisib is now being evaluated across a broad clinical program, including a randomized Phase II study in uveal melanoma (UM), randomized Phase I/II trials in non‑small cell lung cancer (NSCLC) and CLL, and additional Phase I/II studies in myelofibrosis and peripheral T‑cell lymphoma (PTCL). More than 170 patients have been treated so far..

Roginolisib 目前正在广泛的临床项目中进行评估，包括在葡萄膜黑色素瘤 (UM) 中的随机 II 期研究、在非小细胞肺癌 (NSCLC) 和慢性淋巴细胞白血病 (CLL) 中的随机 I/II 期试验，以及在骨髓纤维化和外周 T 细胞淋巴瘤 (PTCL) 中的其他 I/II 期研究。迄今为止，已有超过 170 名患者接受了治疗。

(Press release/AJ)

（新闻稿/AJ）

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