Innovent Reports Oncology Pipeline Updates at Investor Meeting
Innovent Reports Oncology Pipeline Updates at Investor Meeting
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.
中國舊金山和蘇州，2024年6月18日 /PRNewswire/--信達生物製藥有限公司（信達生物）（香港交易所：01801）是一家開發、製造和商業化用於治療腫瘤、代謝、自身免疫、眼科和其他主要疾病的高質量藥物的世界級生物製藥公司，在投資者會議上介紹了其腫瘤產品線的最新情況。在今年的幾次大型國際腫瘤學年會上，信達生物展示了多種抗癌候選藥物的臨床數據，包括10份口頭報告和超過15份海報。在6月17日與投資者的電話會議上，信達詳細解釋了這些藥物的臨床數據。該公司還概述了其當前以全球創新爲中心的研發戰略，以及其正在研發的多種中期和早期候選分子的早期研究機制、開發戰略和未來方向。信達生物學和ADC藥物研究副總裁Rachel You、腫瘤學開發高級副總裁周輝博士以及腫瘤生物學和ADC藥物研究副總裁何凱傑博士出席了會議並作了報告。
Oncology pipeline development strategy: extensively deploy "IO + ADC" to solve unmet clinical needs worldwide
腫瘤學管道開發戰略：廣泛部署 “IO + ADC” 以解決全球未滿足的臨床需求
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.
科學和技術進步穩步提高了癌症患者的存活率和生活質量。但是，癌症治療中仍然存在許多未滿足的臨床需求。其中包括對PD-1等免疫療法的反應率有限，大多數反應會導致復發或產生耐藥性。此外，當前主流療法（例如抗血管生成藥物）的有效性仍然有限。未滿足的重大需求繼續推動腫瘤藥物開發的進一步創新。
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."
信達已建立了36種新候選藥物的產品管線，其中包括22種腫瘤學候選藥物。Innovent利用世界領先的抗體技術平台、差異化的連接器有效載荷和深厚的腫瘤學科學專業知識，廣泛部署了免疫腫瘤學（IO）和抗體藥物偶聯物（ADC）的組合。這種全面的 “IO + ADC” 方法旨在推動全球創新，增強公司腫瘤產品線的品牌定位，該產品線致力於 “進一步拓展生活的可能性”。
Key product milestones: PoC + MRCT driving the globalization of innovative therapies
關鍵產品里程碑：PoC + MRCT 推動創新療法全球化
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.
該公司正在通過臨床概念驗證 (PoC) 研究和全球多區域臨床試驗 (MRCT) 推進其創新腫瘤學產品線。幾種高潛能分子現已進入臨床開發階段，包括三種新型候選藥物 IBI363、IBI343 和 IBI389，電話會議對此進行了詳細討論。Innovent還有其他雙特異性抗體和ADC候選藥物正在全球早期臨床開發中取得進展。
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：同類首創 PD-1/IL-2 α-偏見 雙特異性抗體融合蛋白對多種癌症類型顯示出良好的抗腫瘤功效，包括免疫療法治療和 “感冒” 腫瘤，這表明潛在的下一代IO療法的出現
- 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.
- IBI363 代表了信達在免疫腫瘤學領域的持續研究和創新。在這次會議上，Innovent首次報告了 IBI363 的新型作用機制，並提供了其臨床開發進展的最新情況。
- 關於其分子設計，ICI363 創造性地採用了偏向α的方法，同時削弱了β和γ信號，顯著改善了IL-2的治療窗口。通過與PD-1的特異性結合，它可以選擇性地刺激和擴增共表達 PD-1 和 CD25 的腫瘤特異性 T 細胞，從而發揮抗腫瘤作用。這種新穎的設計利用了細胞因子的激活潛力，同時減輕了全身毒性。
- IBI363 表現出優異的類藥物特性，表現出抗體樣藥代動力學（類IgG PK）和低免疫原性。這使得 IBI363 的劑量達到前所未有的劑量水平，同時保持良好的安全性，克服了通常與 IL-2 治療相關的毒性問題。
- 在涉及 300 多名受試者的 1 期臨床試驗中，IBI363 在多種代表性癌症類型中顯示出令人鼓舞的抗腫瘤療效，包括免疫療法治療的驅動基因野生型非小細胞肺癌、免疫療法治療的純淨粘膜黑色素瘤和免疫學的 “冷” 結直腸癌。這些結果突顯了 IBI363 在不同腫瘤類型和治療環境中的廣譜抗腫瘤潛力。
- 在令人鼓舞的臨床數據基礎上，Innovent正在進一步擴大 IBI363 的臨床開發，包括繼續評估3mg/kg的高劑量隊列以確定後續研究的最佳劑量，在美國啓動2期試驗，以及探索其他聯合療法機會以擴大 IBI363 的潛在應用。
Two CLDN18.2-target based innovative technology modalities, IBI343 and IBI389, showed initial breakthrough efficacy
兩種基於 CLDN18.2 靶標的創新技術模式 IBI343 和 IBI389 顯示出初步的突破性療效
IBI343: Innovative TOPO1i CLDN18.2 ADC, the world's first ADC drug to show initial breakthrough efficacy in pancreatic cancer
IBI343：創新的Topo1i CLDN18.2 ADC，世界上第一個在胰腺癌中顯示出初步突破性療效的ADC藥物
- 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.
- IBI343 是世界領先的創新 TOPO1 抑制劑 CLDN18.2 ADC，其卓越的分子設計採用世界一流的特異性糖聚合物技術，具有很高的體內穩定性。IBI343 與表達 Claudin 18.2 的腫瘤細胞結合，從而導致依賴於 Claudin 18.2 的 ADC 內化。同時，使用高效載荷（exatecan）具有強烈的旁觀者殺死效果。值得注意的是，其 FC 靜音設計減輕了 ADCC 介導的胃腸道毒性，確保了較高的安全性。這種集成設計使 IBI343 處於創新型 CLDN18.2 靶向 ADC 的最前沿。
- 世界上第一個在胰腺癌中顯示出突破性療效的ADC單一藥物：接受過至少一線治療的胰腺癌患者 IBI343 的初步 1 期數據顯示，接受了 6 mg/kg IBI343 的 CLDN18.2 IHC1/2/3+≥ 60% 胰腺癌患者（n=10）的客觀緩解率（ORR）爲 40%。
- 除此之外 胰腺導管腺癌 (PDAC)，IBI343 在晚期胃癌的治療中顯示出強大的抗腫瘤作用，其3期MRCT臨床試驗正在準備中。
IBI389 (anti-CLDN18.2/CD3 bispecific antibody): First-in-class T-cell engager with anti-tumor activity observed in pancreatic cancer
IBI389（抗 CLDN18.2/CD3 雙特異性抗體）：在胰腺癌中觀察到的具有抗腫瘤活性的同類首創 T 細胞參與者
- 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.
- IBI389 是由信達生物開發的一種具有抗 CLDN18.2 T 細胞結合的雙特異性抗體。它通過連接T細胞受體複合物中的CD3分子和腫瘤細胞表面的CLDN18.2抗原來誘導免疫突觸的形成。IBI389 刺激 T 細胞激活，導致細胞溶解蛋白的產生、炎性細胞因子釋放和進一步的 T 細胞增殖，最終產生持久的抗腫瘤作用。臨床前結果表明，即使在 CLDN18.2 表達較低的細胞系中，IBI389 仍能與腫瘤細胞結合並顯示出顯著的抗腫瘤功效。
- IBI389 在晚期胃癌和胰腺癌（包括低至中等 CLDN18.2 表達的病例）中顯示出令人鼓舞的療效信號。值得注意的是，作爲世界上第一個發佈臨床數據的靶向 CLDN18.2/CD3 的雙特異性抗體，IBI389 在胰腺癌中顯示出顯著的初始抗腫瘤作用，這標誌着這種創新藥物在難以治療的癌症領域取得了突破。
- ASCO臨床數據顯示，在接受600微克/千克 IBI389 治療並接受至少一次基線後腫瘤評估的27名胰腺癌受試者中，客觀緩解率（ORR）爲29.6％，確診的客觀緩解率（CorR）爲25.9％，疾病控制率（DCR）爲70.4％。在CLDN18.2 IHC 2/3+≥40％的18名受試者中，CorR達到38.9％。
- 基於早期臨床試驗中證明的 IBI343 和 IBI389 的獨特優勢，信達生物正在推進胃癌 MRCT 3 期臨床試驗的 IBI343 的開發。此外，該公司正在推進針對難以治療的胰腺癌中 IBI343 和 IBI389 的概念驗證臨床研究。
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.
展望未來，信達生物將繼續推進其腫瘤學產品線的高質量臨床開發，解決癌症治療中未得到滿足的醫療需求，並在其 “IO + ADC” 戰略的指導下促進全球創新。
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."
信達生物製藥腫瘤學開發高級副總裁周輝博士， 說：“作爲爲數不多的在IO和ADC方面具有領先研發能力的生物製藥公司之一，我們在下一代腫瘤治療創新方面擁有獨特的競爭優勢。我們將堅持我們的使命，爲全球患者提供價格合理、高質量的生物藥物，旨在使更多患者受益，並支持 “健康中國2030” 倡議。”
Detailed sharing materials can be downloaded from the company's official website, link:
詳細的分享材料可以從公司的官方網站下載，鏈接：
About Innovent Biologics:
關於信達生物製劑：
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.
Innovent是一家領先的生物製藥公司，成立於2011年，其使命是爲全球患者提供價格合理、高質量的生物製藥。該公司發現、開發、製造和商業化針對一些最棘手疾病的創新藥物。其開創性療法治療癌症、心血管和代謝、自身免疫和眼部疾病。信達已在市場上推出了10種產品。它有4項新藥申請正在接受監管審查，4項資產處於III期或關鍵臨床試驗，還有18種分子處於早期臨床階段。信達與30多家全球醫療保健公司合作，包括禮來、賽諾菲、Incyte、Adimab、LG Chem和MD 安德森癌症中心。
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.
在 “從誠信開始，通過行動取得成功” 的座右銘的指導下，Innovent保持最高的行業實踐標準，並共同努力推動生物製藥行業的發展，從而使一流的藥物能夠廣泛獲得。欲了解更多信息，請在臉書和領英上訪問或關注信達生物。
Forward-Looking Statements
前瞻性陳述
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.
本新聞稿可能包含某些前瞻性陳述，這些陳述就其性質而言，存在重大風險和不確定性。與信達生物製藥公司（“信達” 或 “公司”）有關的 “預期”、“相信”、“估計”、“期望”、“打算” 等詞語和類似表述旨在識別某些此類前瞻性陳述。公司不打算定期更新這些前瞻性陳述。
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這些前瞻性陳述基於公司管理層在發表這些陳述時對未來事件的現有信念、假設、預期、估計、預測和理解。這些陳述並不能保證未來的發展，並且受風險、不確定性和其他因素的影響，其中一些因素是公司無法控制的，難以預測。因此，由於我們業務的未來變化或發展、公司的競爭環境以及政治、經濟、法律和社會狀況，實際業績可能與前瞻性陳述中包含的信息存在重大差異。
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SOURCE Innovent Biologics
來源 Innovent Biologics
譯文內容由第三人軟體翻譯。