HanchorBio Presents Late-Breaking Data at FOCIS 2026 Supporting Innate-Immune Product Engine Across Oncology and Autoimmune Disease
HCB101 clinical validation anchors platform expansion into multi-checkpoint immuno-oncology and B-cell-driven autoimmune disease
[Taipei, Shanghai, San Francisco | June 9, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the presentation of late-breaking clinical and translational data at the Federation of Clinical Immunology Societies Annual Meeting, FOCIS 2026, being held June 9-12, 2026, in San Francisco.
The presentation highlights HanchorBio’s SIRPα-based immune engineering platform across three programs: HCB101, targeting the CD47/SIRPα axis, HCB301, targeting CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R pathways, and HCB206, targeting CD20 while engaging CD47/SIRPα biology. The data support HanchorBio’s strategy to build an innate-immune product engine capable of generating differentiated therapeutic candidates across oncology and autoimmune disease.
“FOCIS is an important venue because it allows us to present the immunology behind our platform,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “Our strategy begins with HCB101, where monotherapy data have validated the molecule, and combination-therapy data are defining the clinical development path. From that foundation, we are extending the same SIRPα-based engineering logic into HCB301 for coordinated multi-checkpoint immune reprogramming and HCB206 for B-cell-driven autoimmune diseases.”
HCB101 is HanchorBio’s lead clinical-stage SIRPα-IgG4 Fc fusion protein targeting the CD47-SIRPα innate immune checkpoint. In the ongoing HCB101-101 Phase 1 monotherapy study (NCT05892718), dose escalation reached 36 mg/kg with manageable safety and no maximum tolerated dose identified. In 67 treated patients, treatment-related adverse events were predominantly Grade 1–2, with only 1 case of Grade 3 anemia. Durable monotherapy activity included confirmed partial responses in head and neck squamous cell carcinoma (with ~42% tumor reduction and durability beyond 69 weeks) and marginal zone lymphoma (with ~89% tumor reduction by Week 16), as well as 11 additional cases of durable stable disease.
In combination development, HCB101 is being advanced as the lead clinical anchor in second-line gastric cancer. In the ongoing HCB101-201 combination multi-cohort study (NCT06771622), HCB101 combined with ramucirumab and paclitaxel achieved an overall objective response rate (ORR) of 57.1%, including an 80% ORR in the mature mid-dose cohorts of 5.12 and 8 mg/kg, with deep tumor regressions up to 78.2%. Additional clinical signals, including a confirmed partial response in colorectal cancer with HCB101 and bevacizumab plus FOLFIRI and a confirmed complete response in HNSCC with HCB101 and pembrolizumab, support potential expansion across selected myeloid-dominant tumor settings.
At FOCIS 2026, HanchorBio also presented translational data showing that HCB101 remodeled the tumor immune microenvironment in vivo by increasing tumor-infiltrating leukocytes and macrophages, shifting macrophage polarization toward an M1-dominant phenotype, and enhancing CD4+ and CD8+ T-cell infiltration and activation.
“HCB101 is the clinical proof point for our platform,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “The monotherapy data established safety, pharmacology, receptor occupancy, and early antitumor activity. The combination-therapy data now position second-line gastric cancer as the lead validation path, with colorectal cancer supporting broader GI applicability and head and neck cancer supporting expansion into other myeloid-dominant tumor settings. This is how HCB101 evolves from a CD47-inhibiting molecule into a clinically usable innate immune backbone.”
The FOCIS presentation also highlighted how HanchorBio is extending the HCB101 thesis into next-generation product candidates. HCB301, a tri-specific SIRPα-PD-L1-TGF-β fusion protein, is designed to coordinate innate, adaptive, and stromal immune modulation within a single molecule. Updated early clinical data from the ongoing HCB301-101 Phase 1 study (NCT06487624) showed disease stabilization in heavily pretreated patients at initial dose levels, with predominantly low-grade, on-mechanism cytopenias and reversible hematologic events under active monitoring and mitigation.
HCB206, a SIRPα-CD20 fusion protein, extends the platform into B-cell-driven autoimmune disease. In preclinical studies presented at FOCIS, HCB206 demonstrated picomolar-range B-cell cytotoxicity and enhanced activity in primary B cells from SLE patients. In an SLE patient-derived PBMC-engrafted humanized mouse model, HCB206 induced greater than 90% depletion of splenic CD19+ B cells and rapid suppression of serum anti-dsDNA IgG within seven days, while showing negligible erythrocyte phagocytosis and minimal platelet uptake.
Together, the data support HanchorBio’s view that selective SIRPα-based engineering can serve as a programmable innate-immune backbone and product engine, beginning with HCB101 in oncology and expanding into multi-checkpoint immuno-oncology and autoimmune diseases.
FOCIS 2026 Presentation Details
Title: Clinical and translational validation of CD47-SIRPα engineering enables context-dependent immune circuit reprogramming across oncology and autoimmunity
ID: 2384363
Session: Immuno-Oncology Session
Presentation Date / Time: June 9, 2026 / 5:15 PM – 6:30 PM PST
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (7827.TWSE) is a global clinical-stage biotechnology company focused on immuno-oncology and immune-mediated diseases. The company is led by an experienced team with a proven track record in biologics discovery and global development, aiming to reshape the landscape of cancer therapies. HanchorBio’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics with diverse targeting modalities, designed to activate both innate and adaptive immune pathways and overcome the current challenges of anti-PD1/L1 immunotherapies. The FBDB™ platform has delivered proof-of-concept data in several in vivo tumor animal models. HanchorBio is advancing a portfolio of innovative biologics designed to address significant unmet medical needs through differentiated molecular configurations in R&D and scalable CMC strategies.
Forward-Looking Statements
This press release contains forward-looking statements regarding HanchorBio’s clinical development programs, product candidates, regulatory strategy, and future plans. Actual results may differ materially from those expressed or implied due to various risks and uncertainties, including clinical development outcomes, regulatory decisions, and market conditions. HanchorBio undertakes no obligation to update forward-looking statements except as required by applicable law.
漢康生技於 FOCIS 2026 發表突破性數據，支持先天免疫產品引擎布局腫瘤與自體免疫疾病
HCB101 臨床驗證奠定平台拓展基礎，延伸至多重免疫檢查點腫瘤免疫療法與 B 細胞驅動自體免疫疾病
【台北、上海、舊金山｜2026 年 6 月 9 日】— 漢康生技（TWSE: 7827），一家致力於開發腫瘤與自體免疫疾病下一代免疫療法的全球臨床階段生物科技公司，今日宣布於 臨床免疫學聯合會年會（FOCIS 2026）發表突破性臨床與轉譯數據。FOCIS 2026 於 2026 年 6 月 9 日至 12 日在美國舊金山舉行。
本次發表重點涵蓋漢康生技以 SIRPα 為基礎的免疫工程平台於三項產品中的應用：鎖定 CD47/SIRPα 免疫檢查點的 HCB101、同時針對 CD47/SIRPα、PD-L1/PD-1 與 TGF-β/TGFβ-R 路徑的 HCB301，以及鎖定 CD20 並結合 CD47/SIRPα 生物機制的 HCB206。相關數據支持漢康生技以先天免疫為核心打造產品引擎，並展現其在腫瘤與自體免疫疾病領域開發差異化治療候選藥物的潛力。
「FOCIS 是重要的國際學術平台，使我們能夠呈現公司平台技術背後的免疫學基礎，」漢康生技創辦人、董事長暨執行長劉世高博士表示。「我們的策略以 HCB101 為起點。其單藥治療數據已驗證分子本身的臨床潛力，而聯合治療數據則進一步界定其臨床開發路徑。在此基礎上，我們將相同的 SIRPα 工程設計邏輯延伸至 HCB301，用於協同多重免疫檢查點重編程；並延伸至 HCB206，用於 B 細胞驅動的自體免疫疾病。」
HCB101 是漢康生技領先的臨床階段 SIRPα-IgG4 Fc 融合蛋白，鎖定 CD47-SIRPα 先天免疫檢查點訊號軸。在進行中的 HCB101-101 第 1 期單藥治療試驗（NCT05892718）中，劑量爬升已達 36 mg/kg，整體安全性可控，且未觀察到最大耐受劑量。在 67 名接受治療的患者中，治療相關不良事件主要為 1–2 級，僅出現 1 例 3 級貧血。單藥治療亦觀察到具持續性的臨床活性，包括頭頸部鱗狀細胞癌確認部分緩解（PR；腫瘤縮小約 42%，且療效持續超過 69 週）以及邊緣區淋巴瘤確認部分緩解（PR；至第 16 週腫瘤縮小約 89%），另有 11 例具持續性的疾病穩定（SD）。
在聯合治療方面，HCB101 正作為二線胃癌的主要臨床驗證核心推進。在進行中的 HCB101-201 聯合治療多隊列試驗（NCT06771622）中，HCB101 聯合雷莫蘆單抗（ramucirumab）與 paclitaxel 達到 57.1% 的整體客觀緩解率（ORR）；其中，在較成熟的 5.12 與 8 mg/kg 中劑量隊列中，ORR 達 80%，並觀察到最高達 78.2% 的深度腫瘤縮小。其他臨床訊號亦包括 HCB101 聯合貝伐珠單抗（bevacizumab）與 FOLFIRI 於大腸直腸癌中觀察到確認部分緩解，以及 HCB101 聯合 pembrolizumab 於頭頸部鱗狀細胞癌中觀察到確認完全緩解，支持其在特定髓系細胞主導腫瘤微環境中的進一步拓展潛力。
於 FOCIS 2026，漢康生技亦發表轉譯研究數據，顯示 HCB101 可在體內重塑腫瘤免疫微環境，包括增加腫瘤浸潤白血球與巨噬細胞、使巨噬細胞極化轉向 M1 主導表型，並提升 CD4+ 與 CD8+ T 細胞的浸潤及活化。
「HCB101 是驗證我們平台臨床價值的核心產品，」漢康生技總裁暨醫療長、美國執行長陸英明博士表示。「單藥治療數據已建立其安全性、藥理學、受體佔有率及早期抗腫瘤活性；而聯合治療數據則使二線胃癌成為主要驗證路徑，同時大腸直腸癌數據支持其在更廣泛胃腸道腫瘤中的適用性，頭頸癌數據則支持其拓展至其他髓系細胞主導腫瘤微環境。這正是 HCB101 從一個 CD47 抑制分子，逐步發展為具臨床應用性的先天免疫治療骨幹的過程。」
本次 FOCIS 發表亦說明漢康生技如何將 HCB101 的技術邏輯延伸至下一代候選產品。HCB301 為一款三特異性 SIRPα-PD-L1-TGF-β 融合蛋白，設計目的在於以單一分子協同調控先天免疫、適應性免疫與基質相關免疫機制。來自進行中的 HCB301-101 第 1 期試驗（NCT06487624）更新早期臨床數據顯示，在初始劑量層級中，重度經治患者出現疾病穩定；安全性方面，主要觀察到低等級、符合作用機制的血球低下，以及可逆性血液學事件，目前正透過主動監測與風險降低措施進行管理。
HCB206 為一款 SIRPα-CD20 融合蛋白，將平台應用延伸至 B 細胞驅動的自體免疫疾病。在 FOCIS 發表的臨床前研究中，HCB206 展現皮莫耳等級的 B 細胞細胞毒殺活性，並在來自全身性紅斑狼瘡（SLE）患者的原代 B 細胞中顯示增強活性。在 SLE 患者來源 PBMC 移植的人源化小鼠模型中，HCB206 於七天內誘導超過 90% 的脾臟 CD19+ B 細胞清除，並快速抑制血清 anti-dsDNA IgG，同時顯示可忽略的紅血球吞噬作用及極低的血小板攝取。
整體而言，相關數據支持漢康生技對選擇性 SIRPα 工程設計的觀點：該技術可望成為可程式化的先天免疫治療骨幹與產品引擎，以 HCB101 在腫瘤領域的臨床開發為起點，進一步拓展至多重免疫檢查點腫瘤免疫療法與自體免疫疾病。
FOCIS 2026 發表資訊
Title: Clinical and translational validation of CD47-SIRPα engineering enables context-dependent immune circuit reprogramming across oncology and autoimmunity
ID: 2384363
Session: Immuno-Oncology Session
Presentation Date / Time: June 9, 2026 / 5:15 PM – 6:30 PM PST
關於漢康生技
漢康生技（7827.TWSE）總部位於台北、上海及舊金山灣區，是一家專注於腫瘤免疫及免疫相關疾病的全球臨床階段生物技術公司。公司由具備生物藥探索及全球開發經驗的團隊領導，致力於推動癌症治療領域的創新。漢康生技專有 Fc-based designer biologics（FBDB™）平台可設計具多重功能及多元標靶模式的生物藥，旨在同時活化先天及適應性免疫路徑，並克服現有抗 PD-1/L1 免疫療法所面臨的挑戰。公司正推進多項創新生物藥產品線，透過差異化分子設計及可擴展的 CMC 策略，回應重大未被滿足的醫療需求。
前瞻性聲明
本新聞稿包含有關漢康生技臨床開發計畫、產品候選藥物、法規策略及未來規劃之相關前瞻性聲明。實際結果可能因多項風險與不確定性而與聲明中明示或暗示之內容產生重大差異，包括但不限於臨床開發結果、主管機關決策及市場環境變化。除法律另有要求外，漢康生技無義務更新任何前瞻性聲明。