Ascentage Pharma Announces Clinical Trial Collaboration Agreement with MSD to Evaluate APG-115 in Combination With KEYTRUDA® in Advanced Solid Tumors


2020-07-06 14:30:19 CISION


Ascentage Pharma , a global, clinical-stage biotechnology company developing novel therapies for cancers, chronic hepatitis B , and senesce diseases, today announced a clinical collaboration with MSD to evaluate the combination of APG-115, Ascentage's MDM2-p53 inhibitor, and KEYTRUDA®, MSD's anti-PD-1 therapy, for the treatment of patients with advanced solid tumors. Under the agreement, Ascentage will sponsor an open-label, multicenter, phase Ib/II study (NCT03611868) is designed to evaluate the safety and efficacy of APG-115 with KEYTRUDA® in multiple cohorts of solid tumors (i,e., NSCLC, melanoma, Urothelial cancer, Liposarcoma, MPNST and ATM mutated/p53 WT tumors resistant or relapsed to PD-1/PD-L1 treatment or without previous PD-1/PD-L1 treatment). The Phase II portion of the study has initiated and is expected to enroll 80 patients at multiple sites in the US.  MSD and Ascentage will use a joint development committee to exchange information about the study. Preclinical studies demonstrated that APG-115 promoted the production of proinflammatory cytokines in T cells, enhanced CD4+ T cell activation, and increased PD-L1 expression on various tumor cells. Enhanced antitumor activity was demonstrated in various tumor models after APG-115 was combined with PD-1 blockade. Results of the phase 1b portion of this trial was recently published at ASCO2020 and demonstrated that APG-115 in combination with pembrolizumab is well-tolerated, with encouraging anti-tumor effects in several tumor types. "We are excited to collaborate with MSD, a pharmaceutical industry leader. APG-115 is a key drug candidate in our development pipeline targeting apoptosis, with great potential in the treatment of advanced solid tumors," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Based on the promising Phase Ib data, we are looking forward to working closely with MSD to further study the combination of APG-115 with KEYTRUDA®, potentially offering more effective treatment options to patients with advanced solid tumors." KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. About APG-115 APG-115 is an orally administered, selective, small-molecule inhibitor of the MDM2-p53 PPI. APG-115 has strong binding affinity to MDM2 and is designed to activate p53 tumor suppression activity by blocking the MDM2-p53 PPI. Ascentage Pharma has previously commenced three clinical trials of APG-115 in the US, including a Phase I study as single agent, a Phase Ib/II study in combination with pembrolizumab for treatment of metastatic melanoma and other advanced solid tumors, and a Phase I/II study as a single agent or in combination with chemotherapy for treatment of salivary gland cancer. APG-115 is the first MDM2-p53 inhibitor to enter clinical studies in China. A Phase I study as a single agent, and a Phase Ib study as a single agent or in combination with chemotherapy for treatment of AML (acute myeloid leukemia) or MDS (myelodysplastic syndrome) are ongoing in China. About Ascentage Pharma Ascentage Pharma (6855.HK) is a globally, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and senesce diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 30 Phase I/II clinical trials in the US, Australia, and China. The company's core drug candidate HQP1351 was recently granted orphan drug and fast-track designations by the US Food and Drug Administration (FDA), and a New Drug Application for HQP1351 has been submitted in China. Forward-Looking Statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. SOURCE Ascentage Pharma Related Links
全球临床阶段生物技术公司 Ascentage Pharma 今天宣布与 MSD 进行临床合作,评估 APG-115、 Ascentage 的 MDM2-p53抑制剂以及 KEYTRUDA ®、默沙东(MSD)的抗 PD-1疗法的组合。用于治疗晚期实体瘤患者。 根据协议, Ascentage 将赞助一项开放标签、多中心、 Ib / II 期研究( NCT0361618),旨在评估 APG-115与 KEYTRUDA ®在多组实体肿瘤(即非小细胞肺癌(NSCLC)、黑色素瘤、 Urothelial 癌症、 Liposrcoma )中的安全性和有效性。MPNST 和 ATM 突变/ p53 WT 肿瘤对 PD-1/ PD-L1治疗或无 PD-1/ PD-L1治疗耐药或复发。该研究的第二阶段已经开始,预计将在美国多个地点招收80名患者。默沙东(MSD)和 Ascentage 将使用一个联合开发委员会来交换有关该研究的信息。 临床前研究表明, APG-115促进了 T 细胞中促炎症因子的产生,增强了 CD4+ T 细胞的活化,增加了各种肿瘤细胞上 PD-L1的表达。APG-115联合 PD-1阻断后,多种肿瘤模型均显示抗肿瘤活性增强。这项试验的1b 期部分的结果最近发表在 ASCO2020上,并证明 APG-115与 pembrolizumab 联合使用具有良好的耐受性,在几种肿瘤类型中具有令人鼓舞的抗肿瘤作用。 “我们很高兴能与医药行业的领导者默沙东(MSD)合作。APG-115是我们开发的针对细胞凋亡的药物候选药物,在治疗晚期实体肿瘤方面具有巨大的潜力。基于有希望的 Ib 期数据,我们期待着与默沙东(MSD)密切合作,进一步研究 APG-115与 KEYTRUDA ®的结合,为晚期实体瘤患者提供更有效的治疗方案。 KEYTRUDA ®是 Merck Sharp & Dohme Corp .的注册商标,默克(Merck) Sharp & Dohme Corp .是美国新泽西州 Kenilworth 的子公司。 关于 APG-115 APG-115是 MDM2-p53 PPI 的口服、选择性、小分子抑制剂。APG-115与 MDM2具有较强的结合亲和力,旨在通过阻断 MDM2-p53 PPI 激活 p53肿瘤抑制活性。Ascentage Pharma 此前已在美国开始了 APG-115的三项临床试验,包括一项作为单一药物的 I 期研究、一项与 pembrolizumab 联合用于治疗转移性黑色素瘤和其他晚期实体肿瘤的 Ib / II 期研究。以及 I / II 期作为单一药物或与化疗联合治疗唾液腺癌的研究。APG-115是国内首个进入临床研究的 MDM2-p53抑制剂。中国正在进行 I 期单药研究和 Ib 期单药研究或联合化疗治疗 AML (急性髓系白血病)或 MDS (骨髓增生异常综合征)。 关于 Ascentage Pharma Ascentage Pharma (6855.HK )是一家全球性的、处于临床阶段的生物技术公司,致力于开发治疗癌症、慢性乙型肝炎和老年痴呆症的新疗法。2019年10月28日, Ascentage Pharma 在香港联合交易所有限公司主板上市,股票代码:6855。香港。 Ascentage Pharma 专注于开发抑制蛋白-蛋白相互作用以恢复细胞凋亡或程序性细胞死亡的治疗药物。公司构建了包括新型、高效 Bcl-2、双 Bcl-2/ Bcl-xL 抑制剂在内的8个临床候选药物,以及针对 IAP 和 MDM2-p53通路的候选药物,以及下一代酪氨酸激酶抑制剂。Ascentage Pharma 也是世界上唯一一家以三种已知的关键细胞凋亡调节剂为目标的积极临床方案的公司。公司正在美国、澳大利亚、中国开展30多个 I / II 期临床试验。公司核心药品候选企业 HQP1351于近日被美国食品药品监督管理局( FDA )授予孤儿药和快速适应症,并已在中国提交了 HQP1351新药申请。 前瞻性陈述 本条所作的前瞻性陈述仅涉及截至本条所作陈述之日的事件或信息。除法律要求外,我们不承担任何义务,在作出报表之日之后或为了反映意外事件的发生而公开更新或修订任何前瞻性陈述,无论是由于新信息、未来事件或其他原因。您应该完整阅读本文,并理解我们的实际未来业绩或业绩可能与我们的预期存在重大差异。在本条中,我们或任何董事或本公司的意图或意图的陈述或提述乃于本条日期作出。任何这些意图都可能因未来的发展而改变。 SoURCE Ascentage Pharma 相关链接