IBI363

SAN FRANCISCO and SUZHOU, China, June 18, 2024 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, provided updates on its oncology pipeline at an investor meeting. At several major international oncology annual meetings this year, Innovent presented clinical data on multiple cancer drug candidates, including 10 oral reports and over 15 posters. In a conference call with investors on June 17, Innovent interpreted the clinical data for these drugs in detail. The company also outlined its current R&D strategy centered on global innovation, as well as the early research mechanisms, development strategies and future directions for multiple mid- and early-stage molecular candidates in its pipeline. Innovent's Chief Financial Officer Rachel You, Senior Vice President of Oncology Development Dr. Hui Zhou, and Vice President of Oncology Biology and ADC Drug Research Dr. Kaijie He attended the meeting and made reports. Oncology pipeline development strategy: extensively deploy "IO + ADC" to solve unmet clinical needs worldwide Scientific and technological advancements have steadily increased cancer patient survival rates and quality of life. However, many unmet clinical needs persist in cancer treatment. These include the limited response rates to immunotherapies like PD-1, with most responses resulting in relapse or resistance. Additionally, the effectiveness of current mainstream treatment, such as anti-angiogenic drugs, remains limited. Significant unmet needs continue to drive further innovation in oncology drug development. Innovent has built a product pipeline of 36 new drug candidates, including 22 in oncology. Utilizing a world-leading antibody technology platform, differentiated linker-payloads and deep scientific expertise in oncology, Innovent has extensively deployed a combination of immune-oncology (IO) and antibody-drug conjugates (ADCs). This comprehensive "IO + ADC" approach aims to drive global innovation and enhance the brand positioning for the Company's oncology pipeline, which strives to "further life's possibilities." Key product milestones: PoC + MRCT driving the globalization of innovative therapies The Company is progressing its innovative oncology pipeline through clinical proof-of-concept (PoC) studies and global multi-regional clinical trials (MRCT). Several high-potential molecules have now entered clinical development, including the three novel candidates IBI363, IBI343 and IBI389, which were discussed in detail on the call. Innovent also has additional bispecific antibody and ADC candidates advancing in early global clinical development. IBI363: First-in-class PD-1/IL-2 α-bias bispecific antibody fusion protein shows promising anti-tumor efficacy across multiple cancer types, including in immunotherapy-treated and 'cold' tumors, signaling the emergence of a potential next-generation IO therapy IBI363 represents Innovent's continuous research and innovation in immuno-oncology. At this meeting, Innovent reported for the first time on IBI363's novel mechanical of action and provided updates on its clinical development progress. Regarding its molecular design, ICI363 creatively employs an α-biased approach while weakening β and γ signaling, significantly improving the therapeutic window of IL-2. Through specific binding to PD-1, it can selectively stimulate and amplify tumor-specific T cells that co-express PD-1 and CD25, thereby exerting an anti-tumor effect. The novel design leverages the cytokine's activating potential while mitigating systemic toxicity. IBI363 exhibits excellent drug-like properties, demonstrating antibody-like pharmacokinetics (IgG-like PK) and low immunogenicity. This allows for unprecedented dosing levels of IBI363 while maintaining a favorable safety profile, overcoming the toxicity concerns typically associated with IL-2 therapy. In the Phase 1 clinical trials involving over 300 subjects, IBI363 demonstrated encouraging anti-tumor efficacy across multiple representative cancer types, including immunotherapy-treated driver gene wild-type non-small cell lung cancer, immunotherapy-treated melanoma, immunotherapy treatment-naïve mucosal melanoma, and the immunologically 'cold' colorectal cancer. These results highlight IBI363's broad-spectrum anti-tumor potential across diverse tumor types and treatment settings. Building on the encouraging clinical data, Innovent is further expanding IBI363's clinical development, including continued evaluation of the 3mg/kg high dose cohort to determine the optimal dose for subsequent studies, initiating Phase 2 trials in the United States, and exploring additional combination therapy opportunities to broaden IBI363's potential applications. Two CLDN18.2-target based innovative technology modalities, IBI343 and IBI389, showed initial breakthrough efficacy IBI343: Innovative TOPO1i CLDN18.2 ADC, the world's first ADC drug to show initial breakthrough efficacy in pancreatic cancer IBI343 is a world-leading innovative TOPO1-inhibitor CLDN18.2 ADC that features an excellent molecular design utilizing world-class specific glycoconjugate technology for high in vivo stability. IBI343 binds to the Claudin 18.2-expressing tumor cells, which causes Claudin 18.2-dependent ADC internalization to occur. Meanwhile, the high potency payload (exatecan) is used with strong bystander killing effect. Notably, its Fc-silenced design mitigates ADCC-mediated gastrointestinal toxicity, ensuring a high safety profile. This integrated design positions IBI343 at the forefront of innovative CLDN18.2-targeted ADCs. The world's first ADC single agent to show breakthrough efficacy in pancreatic cancer: Preliminary Phase 1 data of IBI343 in pancreatic cancer patients who had received at least one line of treatment showed that the objective response rate (ORR) was 40% in CLDN18.2 IHC1/2/3+≥60% pancreatic cancer patients (n=10) who received 6 mg/kg IBI343. In addition to pancreatic ductal adenocarcinoma (PDAC), IBI343 has shown strong anti-tumor effects in the treatment of late-line gastric cancer, and its Phase 3 MRCT clinical trial is under preparation. IBI389 (anti-CLDN18.2/CD3 bispecific antibody): First-in-class T-cell engager with anti-tumor activity observed in pancreatic cancer IBI389 is an anti-CLDN18.2 T cell-engaging bispecific antibody developed by Innovent. It induces immune synapse formations by linking CD3 molecules in T-cell receptor complexes and CLDN18.2 antigens on the surfaces of tumor cells. IBI389 stimulates T-cell activation, resulting in cytolytic protein production, inflammatory cytokine release and further T-cell proliferation, which eventually leads to durable anti-tumor effects. Preclinical results show that even in cell lines with low expression of CLDN18.2, IBI389 can still bind to tumor cells and show significant anti-tumor efficacy. IBI389 has shown promising efficacy signals in advanced gastric and pancreatic cancers, including cases with low to medium CLDN18.2 expression. Notably, as the world's first bispecific antibody targeting CLDN18.2/CD3 to publish clinical data, IBI389 has shown significant initial anti-tumor effects in pancreatic cancer, marking a breakthrough for this innovative drug form in the field of difficult-to-treat cancers. ASCO clinical data showed that among 27 pancreatic cancer subjects who received 600μg/kg IBI389 and underwent at least one post-baseline tumor assessment, the objective response rate (ORR) was 29.6%, the confirmed objective response rate (cORR) was 25.9%, and the disease control rate (DCR) was 70.4%. Among the 18 subjects with CLDN18.2 IHC 2/3+≥40%, the cORR reached 38.9%. Based on the unique advantages of IBI343 and IBI389 demonstrated in early clinical trials, Innovent is advancing the development of IBI343 for the MRCT Phase 3 clinical trial in gastric cancer. Additionally, the Company is moving forward with proof-of-concept clinical studies of both IBI343 and IBI389 in the difficulty-to-treat pancreatic cancer. Looking ahead, Innovent will continue to advance the high-quality clinical development of its oncology product line, address unmet medical needs in cancer treatment and promote global innovation guided by its "IO + ADC" strategy. Dr. Hui Zhou, Senior Vice President of Oncology Development at Innovent Biologics, said: "As one of the few biopharmaceutical companies with leading R&D capabilities in both IO and ADC, we possess a unique competitive advantage in next-generation oncology treatment innovations. We will adhere to our mission of empowering patients worldwide with affordable, high-quality biopharmaceuticals, aiming to benefit even more patients and support the Healthy China 2030 initiative." Detailed sharing materials can be downloaded from the company's official website, link: About Innovent Biologics: Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. View original content: SOURCE Innovent Biologics Company Codes: HongKong:1801, OTC-PINK:IVBIY

在今年多个国际肿瘤学年会上，信达生物以10项口头报告和15项壁报形式，展示了多款肿瘤候选药物的临床数据。6月17日，信达生物召开投资者电话会，详细解读产品临床数据，同时介绍了公司目前聚焦全球创新的研发策略，以及重点推进的多款中早期分子差异化的早研机制、开发策略和开发方向。信达生物首席财务官由飞女士、肿瘤开发高级副总裁周辉博士、肿瘤生物学与ADC药物研究副总裁何开杰博士参加会议并进行汇报。 （详细分享材料可在公司官网进行下载，链接：https://investor.innoventbio.com/cn/investors/webcasts-and-presentations/） 肿瘤开发策略：深度布局IO+ADC，解决全球未满足的临床需求 科学技术的进步，让肿瘤患者的生存率和生命质量不断提升。但肿瘤治疗还存在很多未被满足的临床需求，如以PD-1为代表的免疫疗法响应率有限，且绝大多数疾病响应最终都会进展；当前主要治疗手段（如抗血管生成药物）的疗效有限等。 信达生物已经建立了一条包含36个新药品种的产品管线，肿瘤产品管线有22款候选药物。通过发挥全球领先的抗体技术平台、开发差异化的连接体-有效载荷（linker-payload）和对肿瘤科学的深度理解，信达生物深度布局 “肿瘤免疫 (IO) + 抗体药物偶联物(ADC)”，以实现全球创新的战略目标和肿瘤管线“为生命，创无止境”的品牌定位。 重磅产品进展：PoC+MRCT，稳步推进创新产品全球化进程 公司肿瘤产品线通过临床验证（Proof of Concept, PoC）和全球多中心临床试验（MRCT）来推进创新药物开发，目前已有多个高潜力分子进入到临床研究阶段，包括本次进行详细解读的三款全球新分子IBI363，IBI343和IBI389，并拥有更多双特异性抗体和ADC创新分子处于早期全球临床开发过程当中。 IBI363: 全球首创PD-1/IL-2α-bias展现出令人鼓舞的对免疫经治及冷肿瘤的跨肿瘤疗效，新一代IO疗法潜力初现 IBI363作为信达生物自主研发的全球首创药物，代表了公司在IO领域持续不断的研发和创新，本次公司首次报告了其全球新的作用机理和临床开发进展。 分子设计方面，创造性采用α偏向及减弱β、γ的独特思路，极大提升了IL-2的治疗窗口；通过PD-1的特异性牵引，可以选择性刺激和扩增肿瘤内同时表达PD-1和CD25的T细胞，从而发挥抗肿瘤作用。 IBI363展现出了极佳的成药性，具有抗体类似的药代动力学（IgG-like PK）和低免疫原性。这使得IBI363的给药剂量达到史无前例的水平，展现出良好的安全性，突破IL-2疗法的安全性顾虑。 在共入组超过300受试者的临床1期中，IBI363在各项代表性的瘤种中均看到令人鼓舞的疗效，包括既往接受过免疫治疗的驱动基因野生型非小细胞肺癌、接受过免疫治疗的黑色素、未接受过免疫治疗的黏膜型黑色素瘤和冷肿瘤肠癌, 显示了IBI363的广谱抗瘤作用。 基于令人鼓舞的临床数据，信达生物正进一步拓展IBI363的临床开发，包括进一步跟进高剂量3mg/kg的临床结果以决定后续开发剂量、开展美国2期临床、以及探索更多的联合用药机会。 两款基于CLDN18.2靶点的创新技术形态IBI343和IBI389展现出突破疗效 IBI343：创新型TOPO1i CLDN18.2 ADC，全球首个在胰腺癌上展现突破疗效的ADC 药物 全球领先的创新型TOPO1i CLDN18.2 ADC：IBI343采用优异的分子设计，基于世界领先的糖基化定点偶联技术，体内稳定性高；使用强力的有效载荷（伊喜替康）并具有强大的旁观者杀伤作用；Fc沉默效应确保无ADCC介导的胃肠道毒性以保证高体内安全性；以及全人源和高内吞性的CLDN18.2抗体带来的强大靶向效果。 全球首个在胰腺癌上展现疗效突破的ADC药物：IBI343用于至少接受过1线治疗的胰腺癌患者的I期初步数据显示，在接受6 mg/kg IBI343治疗的CLDN18.2 IHC1/2/3+≥60%胰腺癌受试者（n=10）中，客观缓解率（ORR）为 40%。 除PDAC外，IBI343在后线胃癌治疗展现出明确的治疗效果，其MRCT临床3期正在筹备中。 IBI389：全球首创抗CLDN18.2/CD3双特异性抗体，首个胰腺癌中观察到明显获益信号的T细胞连接器 IBI389是信达生物自主研发的全球首创分子，通过同时结合肿瘤细胞上表达的CLDN18.2和T细胞上的CD3，将T细胞重定向到肿瘤细胞，诱导T细胞对肿瘤细胞的杀伤。临床前结果表明，即使在CLDN18.2低表达的细胞系中，IBI389仍能与肿瘤细胞结合，表现出明显的抗肿瘤效力。 IBI389在包括CLDN18.2中低表达人群在内的晚期胃癌和胰腺癌均展现出有潜力的疗效信号。特别是，作为全球首个公布临床数据的靶向CLDN18.2/CD3双抗，IBI389在胰腺癌中观察到明显获益信号，实现了该创新药物形式在难治癌种领域的突破。 ASCO临床数据显示，在27例接受了600μg/kg IBI389治疗并至少进行了一次基线后肿瘤评估的胰腺癌受试者中，客观缓解率（ORR）为29.6%，确认的客观缓解率（cORR）为25.9%，疾病控制率（DCR）达70.4%。在CLDN18.2 IHC 2/3+≥40%的18例受试者中， cORR达38.9%（95%CI：17.3-64.3）。 基于IBI343与IBI389在早期临床及临床开发中展现出来的独特优势，信达生物正推进开发IBI343用于胃癌治疗的MRCT 3期临床，并推进探索IBI343和IBI389于难治肿瘤胰腺癌的验证性临床。 展望未来，信达生物将继续高质量推进肿瘤产品线的临床开发，在 “IO + ADC”战略指引下，探索癌症治疗领域未被满足的医疗需求，并推动全球创新。信达生物制药集团肿瘤开发高级副总裁周辉博士表示：“作为少数兼具IO和ADC领域领先研发能力的生物制药公司，我们将在肿瘤治疗的下一代创新方面具备独特的竞争优势，坚守秉承开发出老百姓用得起的高质量生物药这一使命，惠及更多患者，助力健康中国2030战略落地。” 关于信达生物 - 滑动查看更多介绍 - “始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的使命和目标。信达生物成立于2011年，致力于研发、生产和销售肿瘤、自身免疫、代谢、眼科等重大疾病领域的创新药物，让我们的工作惠及更多的生命。公司已有10个产品获得批准上市，它们分别是信迪利单抗注射液（达伯舒®），贝伐珠单抗注射液（达攸同®），阿达木单抗注射液（苏立信®），利妥昔单抗注射液（达伯华®），佩米替尼片（达伯坦®），奥雷巴替尼片（耐立克®）， 雷莫西尤单抗注射液（希冉择®）*，塞普替尼胶囊（睿妥®）*，伊基奥仑赛注射液（福可苏®）和托莱西单抗注射液（信必乐®）。目前，同时还有4个品种在NMPA审评中，4个新药分子进入III期或关键性临床研究，另外还有18个新药品种已进入临床研究。 公司已与礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson 癌症中心等国际合作方达成30多项战略合作。信达生物在不断自研创新药物、谋求自身发展的同时，秉承经济建设以人民为中心的发展思想。多年来，始终心怀科学善念，坚守“以患者为中心”，心系患者并关注患者家庭，积极履行社会责任。公司陆续发起、参与了多项药品公益援助项目，让越来越多的患者能够得益于生命科学的进步，买得到、用得起高质量的生物药。截至目前，信达生物患者援助项目已惠及17余万普通患者，药物捐赠总价值34亿元人民币。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。 详情请访问公司网站：www.innoventbio.com或公司领英账号Innovent Biologics。 声明：信达生物不推荐未获批的药品/适应症的使用。 *雷莫西尤单抗注射液（希冉择）和塞普替尼胶囊（睿妥）由礼来公司研发。 前瞻性声明 本新闻稿所发布的信息中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。 这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。 本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。