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MIAMI--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic.
迈阿密--(商业新闻短讯)--Summit Therapeutics Inc.(纳斯达克:SMMT)(“Summit”,“we”或“公司”)今天宣布,其新型,潜在的一流研究性双特异性抗体ivonescimab的数据将在捷克共和国布拉格举行的2024年欧洲肺癌大会(ELCC 2024)上提交。
Two posters featuring updated ivonescimab data will be displayed on Friday, March 22 from 12:00 to 12:45pm Central European Time.
中欧时间3月22日(星期五)下午12:00至12:45,将展示两张以更新的ivonescimab数据为特色的海报。
The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline. These patients were enrolled in either AK112-202 (NCT04900363), in which ivonescimab is delivered as monotherapy, or AK112-201 (NCT04736823), in which ivonescimab is delivered in combination with platinum doublet chemotherapy, both of which are Phase II clinical trials for patients with advanced or metastatic NSCLC.
第一张海报“Ivonescimab单独或联合铂类双联化疗治疗晚期非小细胞肺癌(NSCLC)和脑转移患者的颅内活动”包括基线时无症状脑转移患者的数据。这些患者被纳入AK112-202(NCT04900363),其中ivonescimab作为单一疗法递送,或AK112-201(NCT04736823),其中ivonescimab与铂双联化疗联合递送,两者都是晚期或转移性NSCLC患者的II期临床试验。
The second poster titled, “Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Squamous Non-Small Cell Lung Cancer” includes updated data from the Phase II trial AK112-201 centered around the cohort of patients in which ivonescimab is combined with chemotherapy for first line treatment of advanced or metastatic NSCLC in patients without actionable genomic alterations (e.g., positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)).
第二张海报标题为“Ivonescimab的2期结果一种新型PD-1/VEGF双特异性联合化疗用于晚期/转移性鳞状非小细胞肺癌患者的一线治疗”包括来自II期临床试验AK112-201的最新数据,该试验围绕伊伐单抗联合化疗一线治疗晚期或转移性非小细胞肺癌的患者队列,这些患者没有可行的基因组改变(例如,内皮生长因子受体(EGFR)突变或间变性淋巴瘤激酶(ALK)阳性)。
The posters will be presented by, amongst others, Dr. Li Zhang, Sun Yat-Sen University Cancer Center, and Dr. H. Jack West, Vice President of Clinical Development at Summit with data generated and analyzed by our collaboration and licensing partner, Akeso Inc. (HKEX Code: 9926.HK), with contribution by Summit staff.
海报将由中山大学癌症中心的李章博士和Summit临床开发副总裁H.Jack West博士等提供,数据由我们的合作和许可合作伙伴Akeso Inc.(香港交易所代码:9926.HK)生成和分析,并由Summit员工贡献。
Summit continues its clinical development of ivonescimab in order to establish its efficacy and safety in two NSCLC indications:
Summit继续其ivonescimab的临床开发,以确定其在两种NSCLC适应症中的有效性和安全性:
HARMONi Phase III trial: ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI)
HARMONi III期临床试验:ivonescimab联合化疗治疗表皮生长因子受体(EGFR)突变、局部晚期或转移性非鳞状NSCLC患者,这些患者在接受第三代EGFR酪氨酸激酶抑制剂(TKI)治疗后取得进展
HARMONi-3 Phase III trial: ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients
HARMONi-3 III期临床试验:ivonescimab联合化疗治疗一线转移性鳞状NSCLC患者
About the ELCC 2024 Posters
关于ELCC 2024海报
Poster Title: Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
海报标题:新型PD-1/VEGF双特异性联合化疗治疗晚期/转移性鳞状非小细胞肺癌(NSCLC)患者的Ivonescimab的2期结果
ELCC Presentation No.: 68P
ELCC展示编号:68P
Session Date & Time: Friday, March 22, 12:00 to 12:45pm CET
会议日期:3月22日,星期五,欧洲中部时间中午12:00至12:45
Poster Title: Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer and Brain Metastases
海报标题:Ivonescimab单独或联合铂类双联化疗对晚期非小细胞肺癌和脑转移患者的颅内活性
ELCC Presentation No.: 174P
ELCC展示编号:174P
Session Date & Time: Friday, March 22, 12:00 to 12:45pm CET
会议日期:3月22日,星期五,欧洲中部时间中午12:00至12:45
About Ivonescimab
Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is an investigational, novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.
Ivonescimab在Summit的许可证地区,美国,加拿大,欧洲和日本被称为SMT112,在中国和澳大利亚被称为AK112,是一种研究性的,新颖的,潜在的一流双特异性抗体,结合了免疫治疗的作用通过阻断PD-1与阻断VEGF相关的抗血管生成作用形成单一分子。
Ivonescimab displays cooperative binding with each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.
当同时存在PD-1和VEGF时,Ivonescimab以更高的亲和力显示与其每个预期靶标的协同结合。
This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC, 2023).
这可以区分ivonescimab,因为与体内正常组织相比,肿瘤组织和肿瘤微环境(TME)中PD-1和VEGF的表达(存在)可能更高。Ivonescimab的四价结构(四个结合位点)能够在肿瘤微环境中实现更高的亲和力(多重结合相互作用的累积强度),在体外VEGF存在下对PD-1的结合亲和力增加了18倍以上,并且在体外PD-1存在下对VEGF的结合亲和力增加了4倍以上(Zhong等,SITC,2023)。
This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.
这种四价结构,分子的有意新颖设计,以及将这两个靶标引入具有协同结合特性的单一双特异性抗体中,有可能将ivonescimab导向肿瘤组织而不是健康组织。除了与这些目标相关的副作用和安全性外,该设计的目的是改进先前确定的功效阈值。
Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials.
Ivonescimab由Akeso Inc.(香港交易所代码:9926.HK)发现,目前正在进行多个III期临床试验。在全球临床研究中,已有1600多名患者接受了ivonescimab治疗。Summit已开始在非小细胞肺癌(NSCLC)中开发ivonescimab的临床开发,并于2023年开始进行两项III期临床试验。
Ivonescimab is an investigational therapy that is not approved by any regulatory authority.
Ivonescimab是一种未经任何监管机构批准的研究性疗法。
About Summit Therapeutics
关于Summit Therapeutics
Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.
Summit成立于2003年,我们的股票在纳斯达克全球市场上市。我们的总部位于佛罗里达州的迈阿密,在加利福尼亚州的门洛帕克和英国的牛津都设有办事处。
Summit’s mission, in part, is to develop patient, physician, caregiver, and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.
Summit的部分使命是开发患者,医生,护理人员和社会友好的药物疗法,旨在改善生活质量,延长潜在的寿命,并解决严重未满足的医疗需求。