HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025

HanchorBio Announces Oral Presentation of HCB101 at the ESMO Immuno-Oncology Congress 2025

International debut underscores emerging role for macrophage checkpoint therapy in gastric cancer, triple-negative breast cancer, and other hard-to-treat solid tumors

[Taipei, Shanghai, and San Francisco | December 12, 2025] –HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, announced that new clinical data from its flagship macrophage-checkpoint program, HCB101, has been selected for a mini oral presentation at the ESMO Immuno-Oncology Congress 2025 in London, United Kingdom. Only 26 abstracts were chosen for mini-oral presentation this year, marking a major milestone for HanchorBio as it delivers its first-ever oral presentation of clinical data at an international oncology congress, following its prior preclinical oral presentation of HCB101 at SITC 2022.

The ESMO Immuno-Oncology Congress is Europe’s premier meeting dedicated exclusively to immuno-oncology science, distinct from the broader ESMO Annual Congress. While the annual ESMO meeting spans all oncology disciplines, ESMO-IO focuses on immune mechanisms, translational innovation, and next-generation therapeutic strategies across innate and adaptive immunity.

Presentation Details:

Abstract ID:  242MO

Title: HCB101, a Differentiated SIRPα Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity Across Solid Tumors and Lymphoma

First Author: Dr. Fangling Ning, Affiliated Hospital of Binzhou Medical University

Date / Time: 11 December 2025 / 11:45 – 12:45 GMT

Location: Whittle Room, Queen Elizabeth II Centre, London

Presenter: Alvin Luk, PhD, MBA, CCRA – President & CMO (Group) and CEO (U.S.A.), TIME100 Health 2025 Honoree

“For nearly a decade, CD47 therapies were held back not by flawed biology but by flawed molecules, which struggled to balance safety and efficacy at the same time, especially in immunologically cold tumors,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio.  “HCB101 was engineered from the ground up to solve that problem. Using AI-guided structural modeling, we identified three core mutations that reshape SIRPα’s interaction with CD47, allowing us to combine the strengths of first- and second-generation approaches into a single, differentiated molecule. Being selected as one of only 26 mini-oral presentations at ESMO Immuno-Oncology reinforces the field’s recognition of this differentiation. With its clean safety profile, strong target engagement, and early activity in cold tumors, HCB101 is emerging as a true macrophage-checkpoint backbone – much like PD-1/PD-L1 transformed T-cell oncology.”

Key Findings Highlighted in the Mini-Oral

Monotherapy (HCB101-101; NCT05892718)

• Clean, cytopenia-sparing safety across 12 cohorts up to 36 mg/kg QW
• No bleeding events or immune-related toxicities, with the majority of treatment-related adverse events being Grade 1-2
• Linear PK (T_1/2 ~3 days) with receptor occupancy (RO) >90% at ≥8 mg/kg
• Durable antitumor activity, including confirmed PRs in:
  • HNSCC -Head and neck squamous cell carcinoma (~42% tumor regression, ≥32 weeks)
  • MZL – Marginal zone lymphoma (~89% tumor regression, ≥16 weeks)
• Stable disease ≥4-9 months across colorectal cancer (CRC), ovarian cancer, non-small cell lung cancer (NSCLC), and sarcoma

Combination Therapy (HCB101-201; NCT06771622)

• Well-tolerated across gastric cancer (GC), triple-negative breast cancer (TNBC), CRC, and HNSCC
• No new safety signals across all evaluated combinations
• Cytopenias fully attributable to chemotherapy, not HCB101
• 2L GC:
  • 58.3% ORR (7/12) and 100% DCR
  • Tumor shrinkage up to 78.2%
• 1L HER2+ GC: 33% ORR (1/3)
• 1L TNBC: 33% ORR (2/6) and 100% DCR

Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and Chief Executive Officer (U.S.A.) of HanchorBio, added, “The early efficacy signals from HCB101 are unusually compelling for this stage of development. In second-line GC, where standard therapy achieves an ORR of about 28%, HCB101 combinations exceed 58% ORR, with 100% disease control, and tumor reduction approaching 78%. These results are not incremental; they meaningfully exceed expectations and reflect robust macrophage checkpoint engagement. With clean safety and sustained receptor occupancy, the data give us confidence to anchor development in second-line disease and expand into first-line and perioperative settings where depth and durability of response matter most.”

About HCB101: A Next-Generation SIRPα Fc-Fusion Protein

HCB101 is a 3.5^th-generation engineered SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio’s FBDB™ platform to selectively target CD47 while minimizing low red blood cell binding. This design avoids the anemia and thrombocytopenia that limited early anti-CD47 programs, while preserving potent macrophage activation and downstream T-cell engagement.  Key differentiators include:

• Cytopenia-sparing safety up to 30-36 mg/kg
• Receptor occupancy (RO) >90% at clinically active exposures
• Strong macrophage and downstream T-cell activation
• Broad antitumor activity across >80 PDX/CDX models and multiple clinical tumor types
• Robust early combination efficacy in historically CD47-resistant tumors

Unlike earlier approaches, HCB101’s safety, target selectivity, and RO profile support its use as a macrophage-checkpoint backbone – analogous to how PD-1/PD-L1 inhibitors function as foundational T-cell backbones in oncology. HCB101 is designed for broad combinability across established and emerging treatment modalities, including:

• Chemotherapy
• Radiation therapy
• Antibody-drug conjugates (ADCs)
• Anti-PD-1/anti-PD-L1 checkpoint inhibitors
• Anti-VEGF inhibitors
• Anti-EGFR therapies
• Anti-HER2 regimens

This versatility positions HCB101 as a modular, next-generational immuno-oncology component capable of enhancing the efficacy of multiple therapeutic backbones across solid tumors and hematologic malignancies.

漢康生技HCB101獲選2025年ESMO免疫腫瘤學大會口頭報告

國際首秀彰顯巨噬細胞檢查點療法在胃癌、三陰性乳癌等難治實體瘤中的新興潛力

[臺北，上海，舊金山 | 2025年12月12日] – 致力於開發下一代腫瘤及自身免疫疾病免疫療法的全球臨床階段生物技術公司漢康生技（TPEx: 7827）宣佈，其主力創新融合蛋白生物藥HCB101的臨床數據，已被遴選為2025年歐洲腫瘤學會 (ESMO, European Society For Medical Oncology) 免疫腫瘤學大會 (Immuno-Oncology Congress) 的小型口頭簡報，並於英國倫敦舉行。今年僅有26篇摘要獲此報告資格，這意味著漢康生技首次在國際頂級腫瘤學術會議上進行臨床資料口頭報告，是其繼2022年在免疫治療學會大會(SITC, Society for Immunotherapy of Cancer) 上報告HCB101臨床前資料後的又一重大里程碑。

ESMO免疫腫瘤學大會是歐洲專注於免疫腫瘤科學的首要盛會，與涵蓋更廣泛腫瘤領域的 ESMO 年度大會不同，ESMO 年會聚焦於全方位的腫瘤學研究與臨床進展，而免疫腫瘤學大會則專注於免疫機制、轉譯醫學創新，以及涵蓋先天與適應性免疫的下一代治療策略。

報告詳情：

• 摘要編號：242MO
• 標題：HCB101，一款差異化的SIRPα融合蛋白，在實體瘤和淋巴瘤中顯示出良好的安全性和早期抗腫瘤活性
• 第一作者：甯方玲博士，濱州醫學院附屬醫院
• 時間：2025年12月11日，11:45 – 12:45（GMT）
• 地點：倫敦伊莉莎白二世女王中心 (Whittle Room)
• 報告人：陸英明博士 (Alvin Luk) – 集團總裁兼醫療長，2025年《時代》週刊健康領域百大影響力人物

“近十年來，CD47療法的瓶頸並非生物學機制有誤，而在於分子設計本身難以同時顧及安全性與有效性，尤其是在免疫‘冷’腫瘤中，”漢康生技創始人、董事長兼執行長劉世高博士表示。“HCB101從根本上就是為了解決這一問題而設計。通過AI引導的結構建模，我們發現了三個能重塑SIRPα與CD47相互作用的核心突變，從而將第一代和第二代方法的優勢整合在一個獨特的差異化分子中。此次獲選ESMO免疫腫瘤學大會僅有的26項微型口頭報告之一，進一步印證了領域對此差異化的認可。憑藉其純淨的安全性、強大的靶點結合力及在冷腫瘤中的早期活性，HCB101正崛起為一個真正的巨噬細胞檢查點基石療法——正如PD-1/PD-L1曾經改變T細胞腫瘤學一樣。”

口頭報告關鍵資料亮點

單藥治療研究 (HCB101-101; NCT05892718)

• 安全性卓越：在12個劑量佇列中（最高至36 mg/kg，每週一次）均顯示出對血細胞影響輕微的特性。
• 無出血事件或免疫相關毒性：大多數治療相關不良事件為1-2級。
• 線性藥代動力學：半衰期約3天，在劑量≥8 mg/kg時，受體佔有率>90%。
• 持久的抗腫瘤活性，包括以下確認的部分緩解：
  • 頭頸鱗狀細胞癌：腫瘤縮小約42%，緩解持續≥32周。
  • 邊緣區淋巴瘤：腫瘤縮小約89%，緩解持續≥16周。
• 疾病穩定長達4-9個月：見於結直腸癌、卵巢癌、非小細胞肺癌和肉瘤患者。

聯合治療研究 (HCB101-201; NCT06771622)

• 耐受性良好：在胃癌、三陰性乳癌、結直腸癌和頭頸癌中均表現良好。
• 無新的安全性信號：在所有評估的聯合方案中均未出現。
• 全血細胞減少完全歸因於化療，而非HCB101。
• 二線胃癌：
  • 客觀緩解率 (ORR) 達58.3%（7/12），疾病控制率 (DCR) 達100%。
  • 腫瘤直徑最大縮小幅度達78.2%。
• 一線HER2陽性胃癌：客觀緩解率 (ORR) 為33%（1/3）。
• 一線三陰性乳癌：客觀緩解率 (ORR) 為33%（2/6），疾病控制率 (DCR) 達100%。

漢康生技集團總裁兼醫療長陸英明博士補充道：“HCB101在此研發階段所顯示的早期療效信號格外引人注目。在標準療法客觀緩解率 (ORR) 僅約28%的二線胃癌中，HCB101聯合方案的客觀緩解率 (ORR) 超過58%，疾病控制率 (DCR) 達到100%，腫瘤縮小幅度接近78%。這些結果並非微小的改善，而是顯著超越了預期，反映了強而有力的巨噬細胞檢查點啟動。結合安全性和持續的受體佔有率，這些資料使我們有信心將開發重點錨定在二線疾病，並拓展至對緩解深度和持久性要求最高的一線及圍手術期治療 (perioperative treatment，手術前後的治療) 領域。”

關於HCB101：一款新一代SIRPα Fc融合蛋白
HCB101是一款基於漢康生技FBDB™平臺開發的3.5代工程化SIRPα-Fc融合蛋白，具有完整的IgG4 Fc骨架。其設計旨在選擇性靶向CD47，同時極大降低與紅血球的結合，從而避免了限制早期抗CD47藥物開發的貧血和血小板減少問題，同時保留了強大地啟動巨噬細胞及召集下游T細胞的功能。關鍵差異化優勢包括：

• 卓越安全性：劑量高達30-36 mg/kg仍對全血細胞影響輕微。
• 高效的靶點結合：在臨床有效暴露劑量下，受體佔有率>90%。
• 強大的免疫啟動：有效啟動巨噬細胞及下游T細胞。
• 廣泛的抗腫瘤活性：在超過80個PDX/CDX模型及多種臨床腫瘤類型中有效。
• 顯著的早期聯合療效：在對CD47靶向療法歷史上不敏感的腫瘤中顯現。

與早期方法不同，HCB101的安全性、靶點選擇性和受體佔有率特徵，支援其作為一種巨噬細胞檢查點基石療法使用——類似於PD-1/PD-L1抑制劑在腫瘤學中作為T細胞基石療法的角色。HCB101設計用於與現有及新興的治療模式廣泛聯用，包括：

• 化療
• 放療
• 抗體偶聯藥物
• 抗PD-1/PD-L1檢查點抑制劑
• 抗VEGF抑制劑
• 抗EGFR療法
• 抗HER2方案

這種多功能性使HCB101成為一個模組化的、下一代免疫腫瘤元件，有望增強多種治療方案在實體瘤和血液惡性腫瘤中的療效。