HanchorBio Presents Two ASCO 2026 Abstracts Highlighting HCB101 Combination Activity and HCB301 First-in-Human Clinical Progress
Data support HCB101 as a differentiated innate immune checkpoint backbone across monotherapy and standard-of-care combination settings
[Taipei, Shanghai, San Francisco | June 1, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced updated clinical data for HCB101 and HCB301 presented at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
The presentations highlight HanchorBio’s advancing clinical pipeline in innate immunity and multifunctional immuno-oncology. HCB101 is the Company’s differentiated SIRPα-IgG4 Fc fusion protein designed to block the CD47/SIRPα innate immune checkpoint while reducing hematologic liability. HCB301 is a first-in-class tri-specific fusion protein designed to coordinate modulation of CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R pathways within a single molecule.
“We believe the ASCO data further support HCB101 as a differentiated innate immune checkpoint backbone with broad combination potential,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “Using AlphaFold-guided structural modeling within our FBDB™ platform, we engineered HCB101 to enhance and sustain receptor occupancy while reducing the hematologic limitations that challenged earlier anti-CD47 molecules. The emerging clinical data across monotherapy and combination settings support HCB101’s potential for future registrational development.”
Key HCB101 Clinical Highlights Presented at ASCO 2026
In the ongoing HCB101-101 first-in-human Phase 1 monotherapy study, dose escalation has reached 36 mg/kg with manageable safety and no maximum tolerated dose identified. Across 67 treated patients, treatment-related adverse events were predominantly Grade 1–2, with no Grade 3 anemia observed.
HCB101 demonstrated durable monotherapy antitumor activity, including confirmed partial responses in:
- Head and neck squamous cell carcinoma with ~42% tumor reduction and durability beyond 68 weeks
- Marginal zone lymphoma with approximately 89% tumor reduction
- Eleven additional cases of durable stable disease across multiple tumor types
In the HCB101-201 multicohort combination study, HCB101 demonstrated encouraging activity across multiple standard-of-care regimens without compromising partner dosing or introducing unexpected overlapping toxicities.
In second-line gastric cancer, HCB101 combined with ramucirumab and paclitaxel achieved:
- Overall ORR of 57.1% (8/14)
- ORR of 80% in the mature mid-dose cohorts (5.12–8 mg/kg)
- Deep tumor regressions up to 78.2%
- Ongoing responses beyond 34 weeks
Additional combination signals included:
- 80% ORR and 100% DCR in first-line HER2-positive gastric cancer
- 50% ORR and 100% DCR in first-line triple-negative breast cancer
- A confirmed partial response in colorectal cancer
“The HCB101 data presented at ASCO represent one of the broadest clinical datasets reported to date for a macrophage checkpoint inhibitor across monotherapy and multiple combination settings,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “The HCB101-201 data in second-line gastric cancer support a clear development rationale for advancing HCB101 in combination with established standard-of-care therapy as a potential combination-enabling innate immune backbone for future registrational development.”
The HCB301 abstract presents first-in-human Phase 1 data supporting the clinical feasibility of coordinated modulation of innate, adaptive, and TGF-β pathways with a single molecule. As of February 2026, HCB301 demonstrated manageable safety, approximately linear PK, and early evidence of immune modulation in heavily pretreated patients with advanced solid tumors.
“We believe HCB301 represents an important next-generation evolution beyond conventional checkpoint combinations,” added Dr. Luk. “The ability to coordinate SIRPα, PD-L1, and TGF-β modulation within a single molecule may offer a differentiated strategy for immune-resistant tumors.”
ASCO 2026 Presentation Details
HCB101
Title: The differentiated SIRPα-IgG4 Fc fusion protein HCB101 in monotherapy and combination therapy
ID: 2655
Session: Developmental Therapeutics – Immunotherapy Poster Session
Poster Board: 445
Presentation Date / Time: May 30, 2026 / 13:30 – 16:40 CDT
HCB301
Title: First-in-human phase 1 evaluation of the world’s first tri-specific SIRPα-PD-1-TGF-β Fc fusion protein HCB301 in advanced solid tumors
ID: e14570
About HCB101
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein designed to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity associated with earlier-generation CD47-targeted therapies. HCB101 is being evaluated as monotherapy and in combination with standard-of-care regimens across multiple tumor types, including gastric, colorectal, head-and-neck, and triple-negative breast cancers.
About HCB301
HCB301 is an investigational tri-specific fusion protein designed to simultaneously modulate the CD47/SIRPα, PD-L1/PD-1, and TGF-β/TGFβ-R pathways. The molecule is intended to simultaneously trigger innate immune activation, inhibit adaptive checkpoint pathways, and modulate the stroma in a single construct.
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 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 ASCO 2026 發表兩項摘要，展現 HCB101 聯合療法臨床活性與 HCB301 首次人體試驗進展
數據支持 HCB101 作為差異化先天免疫檢查點治療骨幹，具備單藥及標準療法聯合應用潛力
漢康生技（TPEx: 7827），一家致力於開發腫瘤及自體免疫疾病下一代免疫療法的全球臨床階段生物技術公司，今日宣布於美國芝加哥舉行的美國臨床腫瘤學會年會（ASCO 2026）發表 HCB101 與 HCB301 的最新臨床數據。
本次發表展現漢康生技在先天免疫及多功能腫瘤免疫療法領域持續推進的臨床產品線。HCB101 為差異化 SIRPα-IgG4 Fc 融合蛋白，設計用於阻斷 CD47/SIRPα 先天免疫檢查點，同時降低血液學相關風險。HCB301 則為全球首創三靶點融合蛋白，設計用於在單一分子中協同調控 CD47/SIRPα、PD-L1/PD-1 及 TGF-β/TGFβ-R 路徑。
漢康生技創辦人、董事長暨執行長劉世高博士表示：「我們相信，此次 ASCO 發表的數據進一步支持 HCB101 作為差異化先天免疫檢查點治療骨幹，具備廣泛聯合治療潛力。透過 FBDB™ 平台結合AI工具 AlphaFold 輔助結構建模，我們設計 HCB101 以提升並維持受體占有率，同時降低過往抗 CD47 分子所面臨的血液學限制。HCB101 於單藥及聯合治療中的新興臨床數據，支持其未來進入樞紐性臨床開發的潛力。」
ASCO 2026 發表之 HCB101 臨床重點
在進行中的 HCB101-101 首次人體 Phase 1 單藥臨床研究中，劑量爬升已達 36 mg/kg，整體安全性可控，尚未觀察到最大耐受劑量。於 67 名接受治療的患者中，治療相關不良事件多為 Grade 1–2，未觀察到 Grade 3 貧血。
HCB101 單藥治療展現具持續性的抗腫瘤活性，包括：
- 頭頸部鱗狀細胞癌確認部分反應，腫瘤縮小約 42%，療效持續超過 68 週
- 邊緣區淋巴瘤確認部分反應，腫瘤縮小約 89%
- 另有 11 例於多種腫瘤類型中達到持續性疾病穩定
在 HCB101-201 多隊列聯合治療研究中，HCB101 搭配多種標準療法展現令人鼓舞的臨床活性，且未影響合併藥物給藥劑量，亦未觀察到非預期的重疊毒性。
於二線胃癌中，HCB101 聯合雷莫蘆單抗（ramucirumab）及紫杉醇（paclitaxel）達到：
- 整體客觀反應率（ORR）57.1%（8/14）
- 成熟中劑量隊列（5.12–8 mg/kg）ORR 達 80%
- 腫瘤縮小幅度最高達 78.2%
- 療效持續超過 34 週
其他聯合治療訊號包括：
- 一線 HER2 陽性胃癌 ORR 達 80%，疾病控制率（DCR）達 100%
- 一線三陰性乳癌 ORR 達 50%，DCR 達 100%
- 大腸直腸癌中觀察到一例確認部分反應
漢康生技總裁暨醫療長、美國公司執行長陸英明博士表示：「此次於 ASCO 發表的 HCB101 數據，是目前巨噬細胞檢查點抑制劑在單藥及多種聯合治療情境中相對完整的臨床資料之一。HCB101-201 於二線胃癌的數據，支持 HCB101 與既有標準療法聯合使用的清晰開發邏輯，並有望作為未來樞紐性臨床開發中促成聯合療法的先天免疫治療骨幹。」
HCB301 摘要則呈現首次人體 Phase 1 數據，支持透過單一分子協同調控先天免疫、適應性免疫及 TGF-β 路徑的臨床可行性。截至 2026 年 2 月，HCB301 於重度經治晚期實體腫瘤患者中展現可控安全性、近似線性的藥物動力學特徵，並觀察到早期免疫調控證據。
陸英明博士補充：「我們相信 HCB301 代表超越傳統檢查點組合療法的重要下一代演進。透過單一分子協同調控 SIRPα、PD-L1 及 TGF-β，HCB301 可能為免疫抗性腫瘤提供差異化治療策略。」
ASCO 2026 發表資訊
HCB101
Title: The differentiated SIRPα-IgG4 Fc fusion protein HCB101 in monotherapy and combination therapy
ID: 2655
Session: Developmental Therapeutics – Immunotherapy Poster Session
Poster Board: 445
Presentation Date / Time: May 30, 2026 / 13:30–16:40 CDT
HCB301
Title: First-in-human phase 1 evaluation of the world’s first tri-specific SIRPα-PD-1-TGF-β Fc fusion protein HCB301 in advanced solid tumors
ID: e14570
關於 HCB101
HCB101 是經精心設計的 SIRPα–IgG4 Fc 融合蛋白，旨在選擇性阻斷 CD47–SIRPα 先天免疫檢查點，同時降低早期 CD47 標靶療法相關的血液學毒性。HCB101 目前正以單藥及標準療法聯合方式，於胃癌、大腸直腸癌、頭頸癌及三陰性乳癌等多種腫瘤類型中進行評估。
關於 HCB301
HCB301 是一項研究中三靶點融合蛋白，設計用於同時調控 CD47/SIRPα、PD-L1/PD-1 及 TGF-β/TGFβ-R 路徑。此分子旨在於單一結構中同步啟動先天免疫、抑制適應性免疫檢查點路徑，並調節腫瘤基質微環境。
關於漢康生技
漢康生技（7827.TPEx）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。