Ligufalimab

Ivonescimab+AK117    近日，康方生物（9926.HK）宣布其自主研发的全球首创的PD-1/VEGF双特异性抗体依沃西联合新一代D47单抗莱法利（AK117）对比帕博利珠单抗一线治疗PD-L1阳性（CPS≥1）复发转移性头颈部鳞癌（R/M HNSCC）随机、对照、多中心、III期临床研究（AK117-302）完成首例患者入组。华中科技大学同济医学院附属协和医院杨坤禹教授和四川大学华西医院刘磊教授是该研究的共同主要研究者。 AK117-302研究是全球首个CD47单抗疗法治疗实体瘤的Ⅲ期临床研究。该研究是依沃西的第5项以PD-1/L1单抗疗法为阳性对照的Ⅲ期临床研究，也是依沃西第3项以帕博利珠单抗疗法为阳性对照III期临床研究。AK117-302研究体现了公司迭代当前肿瘤免疫治疗格局、建立全球更佳肿瘤标准治疗的决心和信心，也展现了康方生物通过科学的临床布局充分挖掘产品组合临床价值和商业价值的能力。 流行病学数据显示，2022年头颈部肿瘤全球新发病例为77万，中国新发病例为8.4万，其中HNSCC占头颈部肿瘤的90%以上。R/M HNSCC患者5年生存率仅有3.6%。靶向和免疫治疗的获批推动了HNSCC临床治疗的发展，但中位总生存期（OS）仍不足一年。其中，帕博利珠单抗疗法已成为R/M HNSCC的一线标准治疗，是CSCO和NCCN指南首选推荐疗法。PD-1疗法改善了HNSCC的生存获益，但整体生存获益仍有限，部分患者反应不佳。临床亟待更高效的全新疗法的诞生，助力HNSCC患者获得长期生存获益。 ESMO  2024 此前，康方生物已在2024年欧洲肿瘤内科学会（ESMO）年会上报道了该联合疗法的优异疗效。结果显示，对于快速缩瘤需求特别高的HNSCC，莱法利联合依沃西方案具有优异的缩瘤效果和生存获益，取得了高于已披露PD-1研究的初步疗效数据，该疗法有望为HNSCC患者提供全新高效的免疫治疗方案。 关于莱法利 （AK117，CD47单抗） 莱法利单抗是康方生物自主研发的新一代人源化lgG4 单克隆抗体，可与肿瘤细胞上表达的CD47结合，阻断CD47与其受体SIRPα的相互作用，增强吞噬细胞对肿瘤细胞的吞噬活性，从而抑制肿瘤生长。 目前莱法利联合阿扎胞苷治疗血液瘤，莱法利单药或联合依沃西和卡度尼利治疗多种实体瘤的II期临床研究正在高效开展，初步研究疗效数据优异，未观察到剂量限制性毒性事件，表现出优越的安全性。莱法利联合依沃西对比帕博利珠单抗一线治疗PD-L1阳性头颈鳞癌的III期临床研究（AK117-302）完成首例患者入组，联合维奈克拉和阿扎胞苷一线治疗unfit AML的中国II期临床研究、莱法利治疗MDS的国际多中心II期临床研究均在入组中。 关于依达方® （PD-1/VEGF双抗，依沃西） 依达方®（依沃西单抗注射液）是康方生物自主研发的、全球首创PD-1/VEGF双特异性肿瘤免疫治疗药物。依达方®于2024年5月获得中国国家药品监督管理局批准上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，成为全球首个获批上市的“肿瘤免疫+抗血管生成“协同抗肿瘤机制的双特异性抗体新药。 目前，依达方®单药对比帕博利珠单抗单药一线治疗PD-L1表达阳性的晚期NSCLC的III期研究在期中分析中达到了无进展生存期的主要研究终点，获得决定性胜出阳性结果。基于此项研究，依达方®单药一线治疗PD-L1表达阳性的晚期NSCLC已提交sNDA，并获优先审评。同时，依达方®联合化疗对比替雷利珠单抗联合化疗一线治疗sq-NSCLC的III期临床研究，由合作伙伴Summit主导开展的依达方®联合化疗联合化疗用于经第三代EGFR-TKI治疗进展的EGFR突变、局晚期或转移性nsq-NSCLC的国际多中心III期临床研究（HARMONi研究）和依达方®联合化疗对比帕博利珠单抗联合化疗一线治疗sq-NSCLC的国际多中心III期研究正在进行中。 此外，依沃西新启动3项III期临床研究，包括依沃西联合AK117（CD47）联合方案一线治疗PD-L1阳性头颈鳞癌（vs帕博利珠单抗），依沃西联合方案一线治疗胆道癌（vs度伐利尤单抗联合方案），以及依沃西联合方案一线治疗胰腺癌。总体上，依达方®正通过单药和联合用药在包括肺癌、胰腺癌、乳腺癌、肝细胞癌、结直肠癌等17个适应症领域开展了25+项的临床试验。 关于康方生物 康方生物（9926.HK）是一家集研究、开发、生产及商业化全球首创或同类最佳创新生物新药于一体的领先企业。自2012年成立以来，公司打造了独有的端对端康方全方位新药研究开发平台（ACE Platform），建立了以Tetrabody双特异性抗体开发技术、抗体偶联（ADC）技术、mRNA技术及细胞治疗技术为核心的研发创新体系，国际化标准的GMP生产体系和运作模式先进的商业化体系，成为了在全球范围内具有竞争力的生物医药创新公司。 公司已开发了50个以上用于治疗肿瘤、自身免疫、炎症、代谢疾病等重大疾病的创新候选药物，22个候选药已进入临床（包括11个双抗/多抗/双抗ADC），5个新药已在商业化销售，4个新药5个适应症的上市申请处于审评审批阶段。 2021年8月，公司自主研发的差异化PD-1单抗安尼可®获批上市；2022年6月，公司全球首创的PD-1/CTLA-4双抗开坦尼®获批上市，成为全球首个获批的肿瘤免疫治疗双抗新药，也是中国第一个双特异性抗体新药。2024年上半年，开坦尼®一线治疗晚期宫颈癌的新药上市许可申请（sNDA）已受理，开坦尼®联合方案一线治疗晚期胃癌适应症于同年9月获批上市。2024年5月，公司另一全球首创双抗新药依达方®获得中国国家药品监督管理局批准上市，用于EGFR-TKI治疗进展的局部晚期或转移性nsq-NSCLC，依达方®成为全球首个获批的“肿瘤免疫+抗血管生成”机制双抗新药。同期，依沃西对比帕博利珠单抗一线治疗PD-L1阳性NSCLC获显著阳性结果，同适应症的sNDA获CDE受理，并获优先审评。依沃西成为全球迄今唯一在头对头III期临床研究中证明疗效显著优于“药王”帕博利珠单抗的药物，将有望成为一线肺癌治疗新的标准治疗方案，为患者提供全新更优的“去化疗”选择。此前，2022年12月，公司对外许可了依达方®部分海外权益，并以50亿美金+销售提成的合作方案创下了彼时中国单药对外许可的最高交易金额纪录。2024年9月，公司自主研发的伊喜宁®（伊努西单抗，PCSK9）治疗高胆固醇血症两项适应症获批，成为非肿瘤领域的首个获批产品。 康方生物期望通过高效及突破性的研发创新，开发国际首创及同类药物最佳疗法的新药，成为全球领先的生物制药企业。 往期推荐 产品动态 康方生物非肿领域首个新药伊喜宁®（伊努西单抗，PCSK9）治疗高胆固醇血症两项适应症获批上市 产品动态 一线胃癌全人群获批！康方生物卡度尼利获批第二个适应症 数据发布 全球首个对比帕博利珠单抗取得显著阳性结果的随机对照大III期研究——依沃西HARMONi-2重磅研究成果在WCLC发表 临床 进展 康方生物卡度尼利联合方案治疗uHCC的III期临床研究完成首例患者入组 临床 进展 康方AK117（CD47）联合方案治疗MDS国际多中心Ⅱ期临床首例患者入组 临床 进展 针对PD-1/L1治疗进展晚期胃癌，卡度尼利+普络西（VEGFR-2）联合疗法Ⅲ期临床完成首例入组 产品动态 依沃西1L治疗PD-L1阳性NSCLC的sNDA获NMPA受理，肺癌一线将迎“去化疗”新标准方案！ 数据发布 ASCO Oral & JAMA主刊丨Ⅲ期HARMONi-A研究重磅公布，依沃西疗法有望改变EGFR-TKI进展肺癌全球治疗标准 临床 进展 史无前例！康方依沃西单药对比帕博利珠1L治疗PD-L1阳性NSCLC的III期临床获决定性胜出阳性结果 产品动态 依达方®首批发货成功！全国晚期肺癌患者迎来全球最新解决方案 产品动态 康方生物双抗卡度尼利一线治疗晚期宫颈癌全人群的sNDA获CDE受理 企业运营 康方生物上海全球研发中心启动建设 创新全球化战略再提速 产品动态 首个国产新药IL-12/IL-23单抗报产！康方生物依若奇单抗NDA获NMPA受理 临床 进展 国际多中心注册性III期研究HARMONi-3中国启动：依沃西单抗联合化疗对比帕博利珠单抗联合化疗1L治疗sq-NSCLC 临床 进展 依沃西联合化疗对比替雷利珠联合化疗一线治疗sq-NSCLC III期临床试验完成首例给药 产品动态 高达50亿美金！康方生物与Summit就PD-1/VEGF双抗依沃西达成合作和许可协议 产品动态 全球首个肿瘤免疫治疗双抗——开坦尼®（PD-1/CTLA-4双抗，卡度尼利）获批上市

HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso's next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The AK117-302 study represents a significant milestone as the first Phase III clinical trial globally to investigate a CD47 monoclonal antibody therapy for solid tumors. This trial is the fifth Phase III study for ivonescimab, utilizing PD-1/L1 monoclonal antibody therapy as a positive control, and the third Phase III study comparing ivonescimab with pembrolizumab. The AK117-302 trial underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights our capability to maximize the number of cancer patients globally that can benefit from our product portfolio through a strategic approach to clinical development. In 2022, there were 770,000 new cases of head and neck cancer globally, with 84,000 cases reported in China. Squamous cell carcinoma of the head and neck (HNSCC) accounts for over 90% of these cancers. Unfortunately, the five-year survival rate for patients with recurrent/metastatic HNSCC (R/M HNSCC) is just 3.6%. While targeted therapies and immunotherapies have improved treatment options, the median overall survival (OS) remains below one year. Pembrolizumab has emerged as the first-line standard treatment for R/M HNSCC and is recommended in both CSCO and NCCN guidelines. However, many patients do not respond adequately, and the overall survival benefit remains limited. There is a critical unmet need for more effective therapies to help HNSCC patients achieve long-term survival. At the 2024 European Society for Medical Oncology (ESMO) Congress, Akeso reported initial positive data on its combination therapy of ivonescimab and ligufalimab. This combination demonstrated significant tumor reduction and survival benefits, particularly for HNSCC patients, who require rapid tumor shrinkage. The preliminary efficacy data from this therapy surpassed that of previously disclosed PD-1 studies, positioning it as a potentially new immunotherapy option for HNSCC patients. About Ligufalimab (AK117) AK117, independently developed by Akeso, is a next-generation humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors. Currently, several phase II clinical trials are underway to investigate the potential of AK117 in combination with azacitidine for hematological tumors, as well as AK117 alone or in combination with ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles, with no observed dose-limiting toxicity events. Additionally, the Chinese Phase II clinical study of the first-line treatment for unfit AML using AK117 in combination with venetoclax and zzacitidine, as well as the international multicenter Phase II clinical study of AK117 for treating MDS, are both ongoing with patient enrollment. About Ivonescimab (AK112/SMT112) Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them , 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED