HanchorBio to Present Encouraging Early Clinical Activity of HCB101 in Combination with Standard-of-Care Therapy for Second-Line Gastric Cancer at ASCO GI 2026
Early dose-dependent activity supports HCB101 as an innate-immune backbone therapy complementary to the standard second-line gastric cancer treatment
[Taipei, Shanghai, and San Francisco | January 5, 2026] HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that clinical data from its ongoing Phase Ib/IIa study of HCB101 in combination with standard-of-care (SoC) therapy, including ramucirumab and paclitaxel in second-line (2L) gastric cancer, have been accepted for poster presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) 2026, January 8–10, 2026, in San Francisco.
The accepted abstract (Abstract ID: 372) reports encouraging early, dose-dependent antitumor activity and a manageable safety profile in patients with advanced gastric adenocarcinoma that progressed after first-line therapy. Although derived from an early-phase study, the observed response rates and depth of tumor shrinkage exceed those reported in historical studies of standard second-line regimens, including ramucirumab plus paclitaxel evaluated in the global RAINBOW trial (NCT01170663) and the RAINBOW-Asia study (NCT01939899), supporting continued clinical development of this HCB101-based combination.
Second-line gastric cancer represents a globally accepted and operationally well-defined SoC setting, yet clinical outcomes remain limited. HCB101 was engineered to complement, rather than disrupt, this established treatment scheme by enabling innate immune engagement while preserving standard dosing schedules, safety expectations, and routine clinical workflows.
ASCO GI 2026 Presentation Details
- Poster Title: Dose-Dependent Antitumor Activity of HCB101 Plus Ramucirumab and Paclitaxel in Previously Treated Gastric Cancer
- Abstract ID: 372
- Presenter: Dr. Alvin Luk
- Date / Time: January 8, 2026 | 11:30 a.m. – 1:00 p.m. PDT
Additional clinical data and analyses from the ongoing Phase Ib/IIa study will be presented during the ASCO-GI 2026 poster session.
“For many years, the biology of the CD47–SIRPα axis in immune evasion has been well understood, but translating that biology into clinical therapies has been challenging,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “HCB101 was engineered from the outset using AI technologies to solve that problem. Specifically, an engineered SIRPα was designed with markedly enhanced binding affinity for CD47 on tumor cells, while avoiding the hematologic toxicities that limited earlier approaches. Dose-dependent anti-tumor activity was repeatedly observed when HCB101 was combined with the validated, commercially established SoC therapy for 2L GC. This observation provides a clear clinical illustration of how modulation of innate immunity can serve as a foundational, combination-ready immunotherapy backbone.”
Backbone-Centric Mechanistic Rationale
HCB101 is an engineered SIRPα–Fc fusion protein that selectively blocks the CD47–SIRPα innate immune checkpoint, thereby restoring macrophage-mediated tumor clearance while minimizing red blood cell binding. This mechanism is well-suited for combination with existing therapies. Ramucirumab, a cornerstone of second-line gastric cancer treatment, promotes vascular normalization and reduces VEGF-driven immunosuppression, whereas paclitaxel induces immunogenic tumor cell death and antigen release. Together, this regimen integrates innate immune activation into a validated standard-of-care therapy, providing a biologically coherent and clinically practical framework for the antitumor activity observed in 2L gastric cancer.
Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, “Second-line gastric cancer has well-defined clinical benchmarks and treatment regimens that are widely used in routine practice. What stands out in these early data is not only the depth and frequency of tumor responses observed with HCB101 plus ramucirumab and paclitaxel, but also the ability to achieve this activity without compromising the safety profile or real-world deliverability of standard treatment. I look forward to presenting these data at ASCO-GI and discussing their broader implications for the role of innate immune engagement across gastric cancer treatment settings, informed by the strong signals we are observing in second-line disease.”
About HCB101
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed on 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 minimizing red blood cell and platelet binding, which historically limited clinical utility.
Importantly, HCB101 was engineered for compatibility with combinations. Its safety profile, receptor occupancy, and pharmacologic characteristics support seamless integration with established oncology regimens, enabling innate immune engagement without disrupting standard dosing, safety expectations, or clinical workflows. Across clinical and translational studies, HCB101 has demonstrated consistent target engagement and early antitumor activity as monotherapy and in combination, including in tumor settings historically considered challenging for CD47-directed therapies. Together, these attributes position HCB101 as a differentiated macrophage checkpoint backbone for macrophage checkpoint combination strategies across validated treatment frameworks in solid tumors and hematologic malignancies.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TPEx: 7827) is a global biotechnology company specializing in immuno-oncology. It is led by an experienced team of pharmaceutical industry veterans with a proven track record in biologics discovery and international development, aiming to reshape the landscape of cancer therapies. Committed to reactivating the immune system to fight disease, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By advancing breakthroughs in multi-functional, innovative molecular configurations in R&D and improving CMC manufacturing processes, HanchorBio develops transformative medicines to address unmet medical needs.
漢康生技將於2026 ASCO消化道腫瘤大會發布 HCB101 聯合標準治療在二線胃癌中的早期臨床數據
HCB101的劑量依賴性與抗腫瘤活性，支持HCB101與二線胃癌標準治療協同應用的先天免疫“骨幹” 療法
漢康生技股份有限公司（股票代碼：7827），一家致力於開發次世代腫瘤與自體免疫疾病免疫療法的全球臨床階段生技公司，今日宣布其正在進行中的 HCB101 聯合標準治療 (SoC) 方案的 Phase 1b/2a 臨床試驗數據，獲選 2026 年美國臨床腫瘤學會──消化道腫瘤大會 (ASCO GI 2026) 壁報發表。該會議將於 2026 年 1 月 8–10 日 在美國舊金山舉行。
本次獲選之摘要 (Abstract ID：372) 報告顯示，在一線治療失敗後的晚期胃腺癌患者中，HCB101 聯合化療藥物ramucirumab 與 paclitaxel（紫杉醇）展現出明確的、具劑量依賴性的抗腫瘤活性，且整體具優異安全性。
在此早期臨床階段所觀察到的反應率與腫瘤縮小幅度，已大幅優於歷史上二線標準治療的結果，包括全球 RAINBOW 試驗 (NCT01170663) 及 RAINBOW-Asia 試驗 (NCT01939899) 中，ramucirumab 合併 paclitaxel 所展現的臨床療效，進一步支持以 HCB101 為核心的聯合療法持續推進臨床開發。
二線胃癌在全球臨床已為成熟執行的標準治療應用，但整體療效仍存在較大提升空間。HCB101 的設計理念並非改變既有治療框架，而是對其進行「補強而非顛覆」，在不影響標準給藥劑量、安全性預期與日常臨床作業流程的前提下，引入先天免疫調控機制，使其能夠順利融入既有治療體系。
ASCO GI 2026 發表資訊
- 發表標題：Dose-Dependent Antitumor Activity of HCB101 Plus Ramucirumab and Paclitaxel in Previously Treated Gastric Cancer
- 摘要編號：372
- 發表者：陸英明 博士
- 日期／時間：2026 年 1 月 8 日 上午 11:30 – 下午 1:00 (PDT)
更多 Phase 1b/2a 臨床試驗的分析結果與數據，將於 ASCO GI 2026 壁報交流期間同步公佈。
漢康生技創辦人、董事長暨執行長 劉世高 博士 表示：
「多年來，CD47–SIRPα通路在腫瘤免疫逃脫中的作用已被廣泛認知，但將這一生物學機制成功轉化為可行的臨床治療方案，一直面臨較大挑戰。HCB101 自設計之初即結合AI 技術，針對這一核心問題進行系統化優化。我們的工程化設計的 SIRPα 分子顯著提升了 CD47對腫瘤細胞的結合親和力，同時有效避開早期療法常見的血液學毒性限制。在與已被臨床和商業充分驗證的二線胃癌標準治療聯合使用時，反覆觀察到清晰具劑量依賴性的抗腫瘤活性，展示了『先天免疫調控作為具高度相容性的免疫治療骨幹』提供了潛在的臨床價值。」
以「骨幹 (backbone) 療法」為核心的機轉設計邏輯
HCB101 是一款工程化 SIRPα–IgG4 Fc 融合蛋白，可選擇性阻斷 CD47–SIRPα 先天免疫檢查點，恢復巨噬細胞對腫瘤細胞的吞噬作用，同時將紅血球結合風險降至最低，使其在聯合治療中具備良好的安全性基礎。
在二線胃癌標準治療中，ramucirumab 有助於改善腫瘤血管結構並緩解 VEGF介導的免疫抑制，而 paclitaxel 則可誘導免疫原性腫瘤細胞死亡並促進抗原釋放。三者聯用使先天免疫激活機制能夠自然嵌既有的標準治療體系，形成兼具生物學合理性與臨床可操作性的抗腫瘤策略。
漢康生技集團總裁暨醫療長、以及美國子公司執行長 陸英明 博士 補充表示：
「二線胃癌具備明確的臨床基準和廣泛應用的治療流程。本次早期研究中，最值得關注的不僅是 HCB101 聯合 ramucirumab 與 paclitaxel 所展現的腫瘤反應效用，更重要的是，這些療效是在不犧牲既有治療安全性和真實世界臨床可行性的前提下實現的。我期待在 ASCO GI 發表這些成果，並於臨床同行探討先天免疫機制在胃癌治療中的更廣泛應用前景。」
關於 HCB101
HCB101 是一款基於漢康生技自主開發 FBDB™ 平台 理性設計的 SIRPα–IgG4 Fc 融合蛋白，旨在選擇性阻斷 CD47–SIRPα 先天免疫檢查點的同時，最大程度降低將血液學毒性。與早期抗 CD47 療法不同，HCB101 的設計能在保留巨噬細胞抗腫瘤活性的同時，顯著減少對紅血球與血小板的非特異性結合，從而突破了該靶點過往臨床開發中的主要限制。
此外，HCB101 在設計之初即以聯合治療為核心目標。其安全性、受體佔據率 (RO) 及藥代動力學特性，支持其在不干擾標準劑量、安全性預期及臨床流程的前提下，與成熟腫瘤治療方案協應用。迄今為止，HCB101 已在單藥及聯合治療的臨床與轉譯研究中，展現出一致的靶點結合能力和早期抗腫瘤活性，包括在過去被認為對 CD47 靶向療法具挑戰性的腫瘤類型中。這些特性使 HCB101 成為一款具差異化潛力的巨噬細胞檢查點骨幹療法，可廣泛應用於實證成熟的實體瘤與血液腫瘤治療框架中。
關於漢康生技
漢康生技總部設於台北，並於上海與美國舊金山灣區設有據點，是一家專注於免疫腫瘤學的全球生技公司（TPEx：7827）。公司由具備豐富生物製劑研發與國際臨床開發經驗的專業團隊領導，致力於重塑癌症治療版圖。
漢康生技以重新活化免疫系統對抗疾病為使命，其專屬的FBDB™ (Fc-based Designer Biologics) 平台 可開發具多重靶點與多功能設計的創新生物藥，協同啟動先天與後天免疫反應，以突破現行抗 PD-1／PD-L1 治療的限制。FBDB™ 平台已在多項體內腫瘤動物模型中成功建立概念驗證 (PoC)。透過在創新分子設計與 CMC 製程上的持續突破，漢康生技致力於開發具轉化意義的創新藥物，以滿足未被滿足的重大醫療需求。