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康朴生物获FDA批准开展KPG-121联合阿比特龙一线治疗mCPRC的II/III期临床试验

FDA Approved Phase II/III Clinical Study of KPG-121 in Combination with Abiraterone as a First Line Treatment for mCRPC

BioSpace 等信源发布 2024-06-05 08:21

可切换为仅中文


HEFEI, China, June 5, 2024 /PRNewswire/ -- Kangpu Biopharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has recently approved a Phase II/III clinical trial of KPG-121 in combination with Abiraterone for a first-line treatment of metastatic castration resistant prostate cancer (mCRPC)..

中国合肥,2024年6月5日/新华社/--康普生物制药今天宣布,美国食品和药物管理局(FDA)最近批准了KPG-121联合阿比特龙用于转移性去势抵抗性前列腺癌(mCRPC)一线治疗的II/III期临床试验。。

Discovered by Kangpu Biopharmaceuticals, KPG-121 is a modulator of the Cereblon (CRBN) E3 ubiquitin ligase complex CRL4CRBN targeting rapid ubiquitination and degradation of casein kinase 1α (CK1α) and transcription factors Aiolos (IKZF3) and Ikaros (IKZF1). KPG-121 promotes anti-proliferation and anti-angiogenesis activities and enhances immunomodulatory properties.

由康普生物制药公司发现,KPG-121是小脑(CRBN)E3泛素连接酶复合物CRL4CRBN的调节剂,靶向酪蛋白激酶1α(CK1α)和转录因子Aiolos(IKZF3)和Ikaros(IKZF1)的快速泛素化和降解。KPG-121促进抗增殖和抗血管生成活性并增强免疫调节特性。

KPG-121 significantly improves anti-tumor efficacies when combined with androgen-receptor antagonists including enzalutamide, abiraterone acetate, apalutamide, or darolutamide in xenograft models when compared to the androgen-receptor antagonist therapy alone. A Phase I study to evaluate the safety, pharmacokinetics, and efficacy of KPG-121 when combined with enzalutamide, abiraterone, or apalutamide for the treatment of patients with metastatic or non-metastatic castration-resistant prostate cancer was completed in the US (NCT03569280).

与单独的雄激素受体拮抗剂治疗相比,KPG-121与雄激素受体拮抗剂(包括enzalutamide,醋酸阿比特龙,apalutamide或darolutamide)在异种移植模型中联合使用可显着提高抗肿瘤功效。美国完成了一项I期研究,以评估KPG-121与恩扎鲁胺,阿比特龙或阿帕鲁胺联合治疗转移性或非转移性去势抵抗性前列腺癌患者的安全性,药代动力学和疗效(NCT03569280)。

KPG-121 was generally well tolerated and demonstrated a favorable pharmacokinetic profile as well as promising efficacy..

KPG-121通常耐受性良好,并表现出良好的药代动力学特征和有希望的疗效。。

About Kangpu Biopharmaceuticals

康普生物制药简介

Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative small molecules for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions, including targeted protein ubiquitination and degradation.

康普生物制药有限公司是一家临床阶段公司,专注于通过新的解决方案(包括靶向蛋白质泛素化和降解)发现和开发用于治疗实体瘤,血液恶性肿瘤,自身免疫性疾病和炎症性疾病的创新小分子。

Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms, including NeoMIDES®, gDACs®, and X-SYNERGY®..

康普基于专有技术平台(包括NeoMIDES®、gDACs®和X-SYNERGY®)开发了一条强大的潜在一流和一流候选药物管道。。