HanchorBio Highlights Next Generation Combination Backbone Potential, Platform Expansion Beyond Oncology, and Tri-specific Mechanistic Progress at TJCC 2026
Keynote lecture and company symposium highlight clinical validation of HCB101 as an innate-immune combination backbone and present a working mechanistic framework for the tri-specific HCB301 program.
[Taipei, Shanghai, San Francisco | May 04, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced presentations at the 30th Taiwan Joint Cancer Conference (TJCC 2026). Across a keynote lecture and the company symposium, HanchorBio highlighted clinical and translational data supporting HCB101 as a clinically versatile innate immune backbone and presented a working mechanism framework for its next-generation tri-specific program, HCB301.
The presentations emphasized HanchorBio’s broader strategy to address the historical “on-target, off tumor” hematologic liabilities of earlier CD47-targeting agents through a differentiated engineered SIRPα-IgG4 architecture and more clinically feasible combination-therapy design. A recurring theme across both presentations was that the future of the CD47-SIRPα field lies not simply in stronger blockade, but in smarter innate immune engineering and clinically usable combination architecture.
The presentations also prompted active discussion at TJCC around the future of the CD47-SIRPα field, including how next-generation designs may broaden combination utility and extend beyond oncology.
Presentation Details:
- Keynote Lecture: Beyond CD47 Blockade: Redefining the CD47-SIRPα Field for Next-Generation Innate Immunotherapy
- Company Symposium: Reprogramming the CD47-SIRPα Axis in Cancer Immunotherapy: Clinical Validation and Next-Generation Multi-Checkpoint
“Our message at TJCC was straightforward: the CD47-SIRPα biology remains solid and unambiguous, but clinically usable therapeutic design is what determines whether the biology can translate,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “We have cracked the code on the translational barriers that limited the clinical applicability of the first- and second-generation CD47 agents. What is now emerging with HCB101 is a more clinically usable innate immune backbone with activity across multiple treatment settings. With HCB301, we are extending that same engineering logic into complex multi-checkpoint immune reprogramming, while building a more disciplined mechanistic and mitigation framework around safety.”
HCB101: A differentiated innate immune backbone
HanchorBio emphasized that HCB101 has advanced beyond monotherapy validation into combination development across multiple clinically relevant architectures.
- Cracking the hematologic code: Using an AI-guided (AlphaFold) structurally engineered SIRPα-IgG4 architecture, HCB101 has achieved sustained receptor occupancy without reproducing the class-wide hematologic toxicities associated with earlier CD47-directed approaches.
- Second-line gastric cancer anchor: In combination with ramucirumab and paclitaxel, HCB101 has shown an 80% ORR in the mid-dose cohorts (5.12 and 8 mg/kg), with deep tumor shrinkage and early durability.
- Broad signal portability: Early activity was observed in HNSCC, including 1 CR, 1 PR, and 1 SR among 3 Taiwan IIT patients, as well as in 2L CRC, where early translational combination activity has also been observed in the 1b/2a study with a confirmed PR and 3 SDs.
- FDA validated: Recent U.S. FDA Orphan Drug Designation (ODD) in Gastric Cancer reinforces the program’s lead anchor indication. The Company also noted the completion of the U.S. FDA ODD submission for head and neck cancer.
HCB301: A mechanistic framework for multi-checkpoint engineering
The Company also presented an updated framework for understanding and managing the safety profile of HCB301, its tri-specific SIRPα/PD-L1/TGF-β fusion protein designed to address the “triple threat” of immune resistance—innate, adaptive, and stromal.
- The mechanistic breakthrough: HanchorBio described a distinct “V-Curve” platelet pattern in which HCB301-linked drops appear peripheral, transient, and reversible within 24-72 hours, kinetically distinct from classical bone marrow suppression.
- Targeted mitigation strategy: Measures presented included slower infusion rates, step-up dosing, and enhanced early monitoring.
- Preliminary clinical observations: The Company has begun observing preliminary mitigation-related cases with vasodilator support, with no decrease in platelet count seen in these initial cases; additional data collection is in progress.
“What TJCC allowed us to show is that the CD47 field is no longer just about target validity—it is about clinical applicability, combination architecture, and smarter design,” said Alvin Luk, Ph.D., M.B.A., C.C.R.A., President & Chief Medical Officer (Group) and CEO (USA) of HanchorBio. “Across both the keynote lecture and the company symposium, the consistent theme was that the next chapter of CD47 will not be defined by broader blockade alone, but by more usable innate immune engineering—how to preserve macrophage biology, reduce hematologic liability, widen the therapeutic window, and support clinically deployable combination backbones.”
Beyond oncology: platform extension
HanchorBio also framed the CD47 axis as a broader macrophage regulatory checkpoint with potential relevance beyond oncology.
- Autoimmune Disease: HCB206 was presented as a CD47/CD20 program for pathogenic B-cell biology, showing approximately 6-fold greater clearance of pathogenic B cells than competitors in translational models while remaining minimally active in healthy cells.
- CNS and cardiovascular disease: The platform is being extended into glioblastoma, where macrophage/TAM dysfunction may be relevant, and atherosclerosis, where defective efferocytosis may provide a biologic rationale for macrophage-directed intervention.
About HCB101
HCB101 is an AI-guided (AlphaFold) structurally engineered SIRPα-IgG4 Fc fusion protein designed to selectively target the CD47-SIRPα innate immune checkpoint while reducing hematologic toxicity associated with earlier CD47-targeting therapies. The program is being developed as a differentiated innate immune backbone with broad combination potential across multiple tumor types and therapeutic settings.
About HCB206
HCB206 is designed to extend HanchorBio’s selective CD47-SIRPα engineering approach beyond oncology into the field of autoimmune disease. By combining targeted B-cell depletion with an engineered innate immune mechanism intended to minimize unwanted hematologic effects, HCB206 reflects the broader versatility of HanchorBio’s platform across diverse immune-mediated disease settings.
About HCB301
HCB301 is a tri-specific fusion protein designed to integrate modulation of the CD47/SIRPα, PD-1/PD-L1, and TGFβ/ TGFβ-R pathways within a single molecule. By simultaneously addressing multiple interdependent mechanisms of immune resistance, the program reflects HanchorBio’s broader strategy to develop multifunctional biologics with the potential to deliver more coordinated and clinically meaningful immune modulation.
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.
漢康生技於台灣癌症聯合年會展現次世代合併治療骨幹潛力、腫瘤以外平台拓展與三特異性機制進展
主題演講與專題研討會聚焦HCB101作為先天免疫合併治療骨幹的臨床驗證，並提出HCB301三特異性項目的作用機制模型架構
漢康生技（TPEx: 7827）今日宣布，於第30屆台灣癌症聯合年會（TJCC 2026）進行專題演講與公司專題研討會，分享HCB101作為臨床可應用之多功能先天免疫治療骨幹的臨床與轉譯資料，並發表次世代三特異性項目HCB301的作用機制模型架構。
本次發表強調漢康生技的整體策略：透過差異化工程設計的SIRPα-IgG4架構，克服早期CD47標靶藥物常見的「on-target, off-tumor（命中靶點但作用於非腫瘤組織）」血液學限制，並建立更具臨床可行性的合併治療設計。貫穿兩場發表的核心訊息是，CD47-SIRPα領域的未來不僅在於更強的阻斷作用，而在於更精準的先天免疫工程設計與可臨床部署的合併治療架構。
本次發表內容亦引發台灣癌症聯合年會與會者對CD47-SIRPα領域未來發展的高度討論，包括次世代設計如何擴大合併治療應用，並延伸至腫瘤以外的疾病領域。
簡報議程:
- 主題演講: Beyond CD47 Blockade: Redefining the CD47-SIRPα Field for Next-Generation Innate Immunotherapy
- 公司專題研討會: Reprogramming the CD47-SIRPα Axis in Cancer Immunotherapy: Clinical Validation and Next-Generation Multi-Checkpoint
「我們在台灣癌症聯合年會傳達的訊息很明確：CD47-SIRPα生物學仍具高度臨床相關性，但真正決定其能否成功轉譯的是治療設計的臨床可用性，」漢康生技創辦人、董事長暨執行長劉世高博士表示，「我們已突破限制第一代與第二代CD47藥物臨床應用的轉譯障礙。HCB101正逐步展現其作為更具臨床可用性的先天免疫治療骨幹，並可應用於多種治療情境。透過HCB301，我們將相同的工程設計邏輯延伸至複雜的多檢查點免疫重編程，同時建立更嚴謹的安全性機制與緩解策略框架。」
HCB101：差異化先天免疫治療骨幹
漢康生技指出，HCB101已從單藥驗證推進至多種具臨床意義的聯合治療開發架構。
首先，在血液學安全性方面，HCB101透過AI輔助（AlphaFold）與結構工程設計的SIRPα-IgG4架構，達成持續受體佔有率，同時未重現早期CD47藥物常見的累積性血液學毒性。
在二線胃癌治療中，HCB101合併雷莫蘆單抗(ramucirumab)與紫杉醇(paclitaxel)，於中劑量組（5.12與8 mg/kg）展現80%客觀反應率（ORR），並觀察到深度腫瘤縮小與早期療效持續性。
此外，HCB101的治療訊號亦展現跨適應症延展性。在頭頸癌方面，台灣研究者發起的臨床研究（IIT）中3名患者觀察到1例完全緩解（CR）、1例部分緩解（PR）與1例穩定疾病（SD）。在二線大腸直腸癌方面，1b/2a研究亦觀察到早期轉譯合併治療活性，包括1例確認部分緩解與3例穩定疾病。
近期，美國FDA授予HCB101胃癌孤兒藥資格（ODD），進一步支持其作為主要錨定適應症的開發價值。公司亦指出，已完成頭頸癌孤兒藥資格向美國FDA的申請提交。
HCB301：多檢查點工程設計的機制框架
漢康生技亦發表HCB301安全性特徵的最新理解與管理框架。HCB301為三特異性SIRPα/PD-L1/TGF-β融合蛋白，旨在同時針對先天免疫、適應性免疫與基質相關免疫抗性三大機制。
公司指出，HCB301相關血小板變化呈現獨特的「V-Curve」型態，其血小板下降看似屬於周邊性、短暫性且可於24至72小時內恢復，動力學特徵不同於典型骨髓抑制。
針對此一機制特徵，公司提出緩解策略，包括放慢輸注速率、階梯式給藥，以及加強早期監測。初步臨床觀察中，公司已開始觀察與血管擴張劑支持相關的緩解案例，早期個案未見血小板下降；更多資料仍在持續收集中。
「台灣癌症聯合年會讓我們得以呈現，CD47領域已不再只是靶點有效性的問題，而是臨床可用性、合併治療架構與更智慧的設計，」漢康生技集團總裁暨醫療長、美國公司執行長陸英明博士表示。「HCB101正開始證明，工程化先天免疫治療骨幹可部署於多種治療情境；而HCB301則展現相同工程設計理念如何延伸至次世代多檢查點生物學。」
腫瘤以外的平台拓展
漢康生技亦將CD47軸定位為更廣泛的巨噬細胞調控檢查點，具備延伸至腫瘤以外疾病領域的潛力。
在自體免疫疾病方面，公司介紹HCB206作為CD47/CD20項目，針對致病性B細胞生物學進行設計。在轉譯模型中，HCB206對致病性B細胞的清除能力約為競品的6倍，同時對健康細胞維持最低活性。
此外，漢康生技平台亦正延伸至中樞神經與心血管疾病，包括膠質母細胞瘤以及動脈粥狀硬化。前者可能與巨噬細胞／腫瘤相關巨噬細胞功能失調相關，後者則可能與凋亡細胞清除作用受損有關，為巨噬細胞導向介入提供生物學基礎。
關於HCB101
HCB101為AI輔助（AlphaFold）結構工程設計的SIRPα-IgG4 Fc融合蛋白，旨在選擇性標靶CD47-SIRPα先天免疫檢查點，同時降低早期CD47標靶療法相關血液學毒性。該項目正作為差異化先天免疫治療骨幹開發，具備跨多種腫瘤類型與治療情境的廣泛合併治療潛力。
關於HCB206
HCB206旨在將漢康生技選擇性CD47-SIRPα工程設計方法，自腫瘤領域延伸至自體免疫疾病。透過結合標靶B細胞清除與工程化先天免疫機制，並降低不必要的血液學影響，HCB206展現漢康生技平台在多種免疫介導疾病中的應用彈性。
關於HCB301
HCB301為三特異性融合蛋白，設計用於在單一分子中整合調節CD47/SIRPα、PD-1/PD-L1與TGFβ/TGFβ-R路徑。透過同時處理多個相互關聯的免疫抗性機制，該項目體現漢康生技開發多功能生物藥的策略，目標為實現更協調且具臨床意義的免疫調節。
關於漢康生技
漢康生技（股票代碼：7827.TPEx）是一家全球臨床階段的生物技術公司，專注於腫瘤免疫學及自體免疫疾病領域，研發總部設於台北，並在上海及美國舊金山灣區設有運營辦公室。公司由一支在生物藥發現與全球開發方面擁有豐富成功經驗的資深團隊領導，致力於重塑癌症治療格局。漢康生技專有的Fc基礎設計生物藥平台能夠開發具有多種靶向模式的多功能生物藥，旨在激活先天性與適應性免疫通路，以突破當前抗PD-1/L1免疫療法的局限。該平台已在多個體內腫瘤動物模型中成功獲得概念驗證數據。通過差異化的分子研發策略與可規模化的CMC工藝開發，漢康生技正推進一系列創新生物藥管線，致力於解決尚未被滿足的重大醫療需求。