HanchorBio Reports Preliminary First-Line HER2+ Gastric Cancer Data for HCB101, Demonstrating 83.3% ORR
Early clinical observations show deep tumor reductions across dose levels, supporting continued development in combination settings
[Taipei, Shanghai, San Francisco | April 1, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today reported preliminary clinical observations from its ongoing Phase 1b/2a study evaluating HCB101-based combination therapy in first-line HER2-positive gastric cancer.
Among 6 efficacy-evaluable patients treated across multiple dose levels (5.12, 8, and 12 mg/kg), 5 achieved confirmed partial responses (PRs), yielding an objective response rate (ORR) of 83.3%. The disease control rate (DCR) was 100%. Tumor reductions were observed in all evaluable patients, with multiple cases demonstrating deep responses ranging from -30% to -65%. Responses have been observed across dose levels, with patient follow-up ongoing.
While the dataset remains early and limited in size, the observed ORR compares favorably with historical benchmarks for standard-of-care first-line HER2-positive gastric cancer regimens, including studies such as ToGA, JACOB, and KEYNOTE-811, where ORR have generally ranged from approximately 50% to 60%, depending on the regimen and patient population.
The inclusion of dual HER2-directed antibodies (trastuzumab and pertuzumab) in the combination regimen reflects a mechanism-based strategy. Both antibodies provide complementary HER2 epitope coverage and enhance tumor cell opsonization, increasing susceptibility to Fc-mediated effector functions. In the presence of CD47-SIRPα blockade, this dual-antibody configuration may further augment macrophage-mediated phagocytosis and antigen presentation, supporting both innate and downstream adaptive immune activation. This approach is consistent with the design objective of HCB101 to serve as an enabling agent in combination with antibody-based regimens.
Dr. Scott Liu, Founder and Chairman of HanchorBio, said:
“HCB101 was designed to enable innate immune activation in combination settings by selectively blocking the CD47-SIRPα axis while preserving hematologic tolerability. In HER2-positive gastric cancer, combining dual HER2-directed antibodies with CD47 blockade is a mechanism-based approach to increase tumor opsonization and enhance macrophage-mediated phagocytosis. The consistency of tumor reduction observed across patients and dose levels provides early support for this design strategy.”
Despite advances in first-line HER2-positive gastric cancer treatment, including antibody- and immunotherapy-based combinations, clinical benefit remains constrained by the depth and durability of response. Current regimens have improved response rates, but translating these responses into sustained disease control and survival benefit remains an ongoing challenge. The early activity observed with HCB101 in combination with dual HER2-targeted therapy suggests a potentially differentiated approach, where innate immune activation may further enhance the clinical impact of established antibody backbones. Continued enrollment and follow-up will be important to determine the magnitude and durability of the benefit.
HCB101 is a rationally engineered SIRPα-IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform to selectively block the CD47-SIRPα innate immune checkpoint while minimizing hematologic toxicity. By reducing red block cell binding while preserving macrophage-mediated phagocytosis, HCB101 is designed to enable combination use with established antibody- and chemotherapy-based regimens.
In preclinical studies, HCB101 demonstrated robust antitumor activity across multiple gastric cancer animal models, including HER2-positive models and patient-derived xenograft (PDX) models, with tumor growth inhibition (TGI) ranging from 83% to 110%. The current clinical observations provide early translational support for findings.
HanchorBio is currently advancing HCB101 in multiple combination studies across gastric cancer, colorectal cancer, head and neck cancer, and triple-negative breast cancer. Ongoing enrollment and follow-up are expected to further characterize safety, dose optimization, durability of response, and survival outcomes, and to define the potential role of HCB101 within combination paradigms.
About HCB101
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing red blood cell binding, a limitation that historically constrained development across the CD47 class. HCB101 is being evaluated across multiple clinical settings as both monotherapy and combination therapy.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TPEx) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The company’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics intended to modulate innate and adaptive immune pathways with structural control over safety, exposure, and manufacturability. HanchorBio is advancing a portfolio of differentiated biologics designed to address significant unmet medical needs through innovative molecular engineering and scalable CMC strategies.
漢康生技公布HCB101 HER2陽性胃癌一線治療初步數據 ORR達 83.3%
早期臨床觀察顯示，跨劑量層級皆見深度腫瘤縮減，支持其於聯合治療架構中的持續開發
漢康生技為一家全球臨床階段生技公司，致力於推進腫瘤與自體免疫疾病的次世代免疫療法。公司公布其正在進行中的 HCB101 聯合療法臨床 1b/2a 期試驗於 HER2陽性胃癌一線治療的初步臨床觀察結果。
在 6 位療效可評估、接受不同劑量層級（5.12、8 與 12 mg/kg）治療的患者中，有 5 位達到已確認之部分緩解（PR），客觀緩解率（ORR）為 83.3%；疾病控制率（DCR）為 100%。所有可評估患者皆觀察到腫瘤縮減，其中多位患者呈現深度反應，腫瘤縮減幅度介於 -30% 至 -65%。目前於不同劑量層級皆已觀察到療效反應，患者追蹤仍在持續進行中。
雖然目前資料仍屬早期，且樣本數有限，但此次觀察到的 ORR 與 HER2陽性胃癌一線標準療法的歷史參考數據相比，具備正向參考意義。包括 ToGA、JACOB 與 KEYNOTE-811 等研究在內，不同療法組合與病人族群的一線治療 ORR，大致介於約 50% 至 60% 之間。
此次聯合療法中納入兩種 HER2 導向抗體——曲妥珠單抗（trastuzumab）與帕妥珠單抗（pertuzumab）——反映出一項以作用機轉為基礎的設計策略。兩者可提供互補性的 HER2 表位覆蓋，並增強腫瘤細胞調理作用（opsonization），進而提升 Fc 介導效應功能的敏感性。在 CD47-SIRPα 阻斷存在下，這種雙抗體配置可能進一步增強巨噬細胞介導的吞噬作用與抗原呈遞，支持先天免疫及後續適應性免疫的活化。此一策略也與 HCB101 作為抗體聯合治療賦能分子的設計目標一致。
漢康生技創辦人暨董事長劉世高博士表示：「HCB101 的設計目的，是在聯合治療情境中，透過選擇性阻斷 CD47-SIRPα 軸線來啟動先天免疫，同時維持良好的血液學耐受性。在 HER2陽性胃癌中，將雙 HER2 導向抗體與 CD47 阻斷機制結合，是一項基於作用機轉的治療策略，可望增加腫瘤細胞調理作用，並增強巨噬細胞介導的吞噬活性。此次在不同患者與劑量層級中觀察到一致的腫瘤縮減，為這項設計策略提供了早期支持。」
儘管 HER2陽性胃癌一線治療近年已因抗體與免疫治療聯合方案而有所進展，但臨床效益仍受到反應深度與持續性的限制。現行療法雖已提升反應率，但如何將這些反應轉化為更持久的疾病控制與存活效益，仍是臨床上的持續挑戰。HCB101 聯合雙 HER2 標靶療法目前所呈現的早期活性，顯示其可能代表一種具有差異化潛力的治療途徑，即透過先天免疫活化，進一步提升既有抗體骨幹療法的臨床效益。後續持續收案與追蹤，將有助於進一步釐清其效益幅度與持續性。
在臨床前研究中，HCB101 已於多種胃癌動物模型中展現強勁的抗腫瘤活性，包括 HER2陽性胃癌模型與病人腫瘤移植動物模型（PDX）。其中，PDX 模型所觀察到的腫瘤生長抑制率（TGI）達 83% 至 110%，顯示 HCB101 在胃癌領域具有一致性的抗腫瘤訊號。本次臨床觀察結果，也為先前研究發現提供了初步的轉譯支持。
目前，漢康生技正於胃癌、結直腸癌、頭頸癌與三陰性乳癌等多個適應症中推進 HCB101 聯合療法研究。隨著持續收案與後續追蹤，公司預期將進一步探討其安全性、劑量最佳化、反應持續性與存活結果，並界定 HCB101 在聯合治療架構中的潛在角色。
關於HCB101
HCB101為漢康生技以FBDB™平台理性設計開發之SIRPα–IgG4Fc融合蛋白，旨在選擇性阻斷CD47–SIRPα先天免疫檢查點，同時降低血液學毒性。不同於早期的抗CD47，HCB101在保留巨噬細胞介導抗腫瘤活性的同時，降低對紅血球CD47的結合能力，以克服過去限制該療法發展的關鍵挑戰。
透過AI輔助結構建模，HCB101對腫瘤細胞上的CD47具差異化結合特性，並維持對紅血球CD47的低親和力。其安全性、受體佔有率與藥理特性，皆有利於與既有腫瘤治療方案整合。目前HCB101正於胃癌、大腸直腸癌及頭頸癌等適應症持續進行劑量遞增與臨床二期擴展研究。
綜合上述特質，HCB101已定位為具備差異化的先天免疫檢查點骨幹（Backbone），並具備橫跨實體腫瘤與血液腫瘤的廣泛潛力。
關於漢康生技
漢康生技（證券代碼：7827.TPEx）總部位於台北、上海與舊金山灣區，是一家全球臨床階段生技公司，專注於腫瘤免疫治療與免疫相關疾病新藥開發。公司由具備生物藥研發與全球開發實績的團隊領導，致力於透過創新分子設計重塑癌症治療格局。
漢康生技所開發的Fc-based designer biologics（FBDB™）平台可設計多功能生物藥，透過多元標的組合，同步激活先天與後天免疫路徑，並克服現有anti-PD1/L1免疫療法所面臨的挑戰。透過在多功能生物藥研發領域的突破，以及具備高擴展性的CMC（化學製造與管制）策略，漢康生技正加速推進創新藥物管線，以解決尚未被滿足的重大醫療需求。