HanchorBio Advances Macrophage-Directed Immunotherapy at SITC 2026, Highlighting Clinical Progress and Next-Generation Trispecific Innovation
HCB101 (SIRPα–IgG4) clinical findings support a differentiated innate combination backbone and global registrational development in gastric cancer.
HCB301 and IND-cleared HCB303 demonstrate the expansion of HanchorBio’s proprietary FBDB™ platform into multi-axis immunotherapy.
TAIPEI, SHANGHAI, and SAN FRANCISCO — November 9, 2026 — HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation multi-functional biologics, today highlighted findings from four scientific presentations at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting in Phoenix, Arizona.
The presentations demonstrated progress across HanchorBio’s clinical and preclinical pipeline, reinforcing its strategy to advance cancer immunotherapy beyond individual checkpoints through coordinated innate and adaptive immune modulation.
“The next generation of immunotherapy must go beyond blocking individual checkpoints and unlock the potential of myeloid-directed immunity,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “Despite advances in immunotherapy, cold and refractory solid tumors remain a major challenge. HCB101’s engineered SIRPα–IgG4 Fc architecture and emerging clinical evidence support its development as a versatile macrophage-directed combination backbone. With HCB301 and IND-cleared HCB303, we are extending our myeloid-directed biology into next-generation trispecific immunotherapies that integrate innate and adaptive immune mechanisms.”
HCB101: Building a Macrophage-Directed Combination Backbone
HCB101 is an engineered SIRPα–IgG4 Fc fusion protein designed to block the CD47–SIRPα innate immune checkpoint while minimizing red blood cell interactions. Unlike conventional CD47 inhibitors incorporating effector-silenced IgG1 Fc, HCB101’s architecture retains calibrated FcγR engagement, supported by published preclinical evidence of macrophage-mediated tumor clearance.
Lead Indication in 2L Gastric / GEJ Cancer: In the ongoing Phase 1b/2a HCB101-201 study, HCB101 in combination with ramucirumab and paclitaxel has demonstrated encouraging preliminary antitumor activity and disease control in second-line gastric and gastroesophageal junction (GEJ) cancer. Following U.S. FDA and China CDE consultations and supported by Orphan Drug Designation, HanchorBio is advancing dose and regimen optimization, including every-two-week dosing, toward a planned randomized, global registration-enabling Phase 2b regimen-selection study followed by a confirmatory Phase 3 evaluation.
Microsatellite-Stable Colorectal Cancer (MSS-CRC): In a difficult-to-treat population with microsatellite-stable colorectal cancer (MSS-CRC) who had progressed following PD-1 therapy, HCB101 demonstrated preliminary antitumor activity across bevacizumab-, cetuximab-, and ramucirumab-based chemotherapy regimens. Complementary Taiwan investigator-initiated observations demonstrated prolonged disease control exceeding 66 weeks at a low HCB101 dose (2.56 mg/kg), supporting further investigation of macrophage-directed immunotherapy in historically checkpoint-resistant population.
Durable Monotherapy Activity in HNSCC: In the Phase 1a HCB101-101 trial, a heavily pretreated patient with recurrent/metastatic head and neck squamous cell carcinoma refractory to anti-PD-1 therapy and radiation achieved a confirmed partial response, with sustained clinical benefit extending past 83 weeks. The U.S. FDA subsequently authorized continued treatment through a single-patient Expanded Access protocol. Additional cohort evaluations of HCB101 combined with PD-1 and EGFR inhibitors are ongoing.
These observations provide a clinical rationale for exploring HCB101 with PD-1- and EGFR-directed therapies and future combinations involving next-generation immunotherapies, tumor-targeted agents, and therapeutic cancer vaccines.
Together, these findings support HCB101’s development as a macrophage-directed innate immune checkpoint backbone across multiple cancer indications, with controlled studies required to establish its incremental clinical benefit.
Expanding the Frontier: Next-Generation Trispecific Biologics
HanchorBio’s multi-specific pipeline leverages the FBDB™ platform to integrate complementary multi-pathway targeting into single, manufacturable fusion proteins:
HCB303 (Trispecific SIRPα / PD-L1 / TIGIT Decoy): Preclinical data presented at SITC demonstrate coordinated activation of macrophages, T cells, and NK cells. Engineered with a proprietary TIGIT decoy designed to preserve downstream CD226 costimulatory signaling—overcoming a key limitation of first-generation anti-TIGIT monoclonal antibodies—HCB303 showed potent, coordinated antitumor activity in benchmark in vivo models. HCB303 recently received U.S. FDA Investigational New Drug (IND) clearance to initiate clinical development.
HCB301 (Trispecific SIRPα / PD-L1 / TGF-β Trap): First-in-human dose-escalation results demonstrated proof-of-mechanism and initial disease stabilization in advanced solid tumors. The study characterized dose-dependent biological effects and identified transient thrombocytopenia as a dose-dependent safety consideration, informing ongoing pharmacokinetic/pharmacodynamic modeling, dosing schedule optimization, and therapeutic window refinement.
Together, these programs demonstrate the continued expansion of HanchorBio’s FBDB™ platform toward coordinated innate and adaptive immune modulation.
SITC 2026 Presentation Details
- HCB101 Platform Engineering and Combination Strategy
Title: CD47–SIRPα engineering and combination development
Abstract Number: #578
Section Date/Time: Friday, November 6, 2026
- HCB101 in Recurrent/Metastatic HNSCC
Title: Durable monotherapy and PD-1/EGFR combination activity in HNSCC
Abstract Number: #526
Section Date/Time: Friday, November 6, 2026
- HCB301 Phase 1 Dose Escalation
Title: First-in-human trispecific immune modulation in advanced solid tumors
Abstract Number: #565
Section Date/Time: Saturday, November 7, 2026
- HCB303 Preclinical Proof-of-Concept
Title: Trispecific SIRPα/PD-L1/TIGIT-decoy demonstrates multi-lineage immune activation
Abstract Number: #399
Section Date/Time: Saturday, November 7, 2026
About HanchorBio
HanchorBio (TWSE: 7827) is a global clinical-stage biotechnology company pioneering next-generation immuno-oncology therapies through its proprietary Fc-Based Designer Biologics (FBDB™) platform. By combining multi-axis targeting with tuned immune effector engagement, HanchorBio develops breakthrough therapeutics that overcome tumor resistance mechanisms across innate and adaptive pathways. Operating across Taipei, the San Francisco Bay Area, and Shanghai, HanchorBio is advancing a clinical and preclinical pipeline spanning multi-functional fusion proteins for hard-to-treat solid tumors and autoimmune disorders. For more information, visit: www.HanchorBio.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding HanchorBio’s investigational products, proprietary technologies, clinical development programs, potential therapeutic applications, and future combination strategies. These statements involve scientific, clinical, regulatory, operational, and commercial risks and uncertainties. Preliminary clinical and preclinical findings may not predict future outcomes, and adequately controlled clinical trials have not established the safety, efficacy, and incremental clinical benefit of HanchorBio’s investigational therapies. Actual results and future development activities may differ materially from current expectations. Except as required by applicable law, HanchorBio undertakes no obligation to update or revise these statements.
HanchorBio Business Development Contact:
Email: [email protected]
Investor & Media Contact:
Email: [email protected]
漢康生技於癌症免疫治療學會年會展現巨噬細胞導向免疫療法進展 發表臨床進度與新一代三特異性創新技術
HCB101（SIRPα–IgG4）臨床研究結果支持其作為具差異化的先天免疫聯合治療基礎，並推進胃癌全球註冊臨床開發
HCB301 與已獲 IND 核准的 HCB303，展現漢康生技專有 FBDB™ 平台拓展至多重免疫路徑治療的研發潛力
【台北、上海、舊金山，2026 年 11 月 9 日】－全球臨床階段生技公司漢康生技（TWSE：7827）致力於開發新一代多功能生物藥，今日公布於美國亞利桑那州鳳凰城舉行的「2026 年癌症免疫治療學會年會」（Society for Immunotherapy of Cancer，SITC）中，四項科學研究發表的主要成果。
本次發表展現漢康生技臨床及臨床前產品管線的研發進展，進一步強化公司超越單一免疫檢查點抑制策略，透過協同調控先天性與適應性免疫反應，推動癌症免疫治療發展的策略方向。
漢康生技創辦人、董事長暨執行長劉世高博士表示：「下一代免疫療法必須超越單一免疫檢查點的阻斷，進一步釋放髓系細胞導向免疫反應的潛力。儘管免疫療法已取得重要進展，免疫冷腫瘤及難治型實體腫瘤仍是臨床治療面臨的重大挑戰。HCB101 經工程化設計的 SIRPα–IgG4 Fc 分子架構，以及持續累積的臨床證據，支持其發展為具廣泛應用潛力的巨噬細胞導向聯合治療基礎。隨著 HCB301 及已獲 IND 核准的 HCB303 持續推進，我們正將髓系細胞導向的免疫生物學機制延伸至新一代三特異性免疫療法，整合先天性與適應性免疫作用機制。」
HCB101：建立巨噬細胞導向的聯合治療基礎
HCB101 為經工程化設計的 SIRPα–IgG4 Fc 融合蛋白，旨在阻斷 CD47–SIRPα 先天性免疫檢查點，同時降低與紅血球的交互作用。不同於採用效應功能靜默化 IgG1 Fc 的傳統 CD47 抑制劑，HCB101 的分子架構保留經適當調控的 FcγR 結合能力，且已有公開發表的臨床前研究證據支持其透過巨噬細胞介導腫瘤清除的作用機制。
二線胃癌及胃食道交界部癌：主要開發適應症
在持續進行的第一b/二a期（Phase 1b/2a）HCB101-201 臨床試驗中，HCB101 聯合雷莫蘆單抗（ramucirumab）及紫杉醇（paclitaxel），於二線胃癌及胃食道交界部癌（GEJ）患者中，展現令人鼓舞的初步抗腫瘤活性與疾病控制潛力。
在與美國食品藥物管理局（FDA）及中國大陸國家藥品監督管理局藥品審評中心（CDE）進行諮詢，並取得孤兒藥資格認定的支持下，漢康生技正持續優化劑量與給藥方案，包括每兩週給藥一次的方式，以推進規劃中的全球隨機分組第二期 b 臨床試驗，進行治療方案篩選並支持註冊開發，後續將進一步展開第三期確認性臨床試驗。
微衛星穩定型大腸直腸癌（MSS-CRC）
針對接受 PD-1 治療後疾病仍持續惡化、治療難度較高的微衛星穩定型大腸直腸癌（MSS-CRC）患者，HCB101 在分別以貝伐珠單抗（bevacizumab）、西妥昔單抗（cetuximab）及雷莫蘆單抗（ramucirumab）為基礎的化學治療方案中，展現初步抗腫瘤活性。
此外，台灣研究者發起的臨床研究亦觀察到，在 HCB101 低劑量（2.56 mg/kg）下，患者的疾病控制時間超過 66 週。這些觀察結果支持進一步探索巨噬細胞導向免疫療法，應用於過去對免疫檢查點治療反應不佳的患者族群。
頭頸部鱗狀細胞癌（HNSCC）：單藥治療展現持續性臨床活性
在第一a期（Phase 1a）HCB101-101 臨床試驗中，一名曾接受多線治療、對抗 PD-1 治療及放射線治療具有抗藥性的復發性／轉移性頭頸部鱗狀細胞癌患者，接受 HCB101 單藥治療後，達到經確認的部分緩解（PR），且持續獲得超過 83 週的臨床受益。
美國 FDA 隨後核准該患者透過單一病人擴大使用（Expanded Access）機制持續接受治療。目前，HCB101 聯合 PD-1 及 EGFR 抑制劑的其他研究組別評估亦持續進行中。
上述臨床觀察結果，為進一步探索 HCB101 與 PD-1、EGFR 標靶療法，以及未來結合新一代免疫療法、腫瘤標靶藥物與治療性癌症疫苗的聯合治療策略，提供臨床研究依據。
整體而言，這些研究結果支持 HCB101 作為巨噬細胞導向先天性免疫檢查點治療基礎，持續拓展至多項癌症適應症；惟其額外臨床效益仍須透過對照臨床試驗進一步確認。
拓展免疫治療新領域：新一代三特異性生物藥
漢康生技透過專有 FBDB™ 平台，將具有互補作用的多重免疫路徑標靶整合至單一、具可製造性的融合蛋白，持續推進多特異性生物藥產品管線的開發。
HCB303（三特異性 SIRPα／PD-L1／TIGIT 誘餌受體）
本次於 SITC 發表的臨床前研究數據顯示，HCB303 可協同活化巨噬細胞、T 細胞及自然殺手細胞（NK 細胞）。
HCB303 採用專有的 TIGIT 誘餌受體設計，旨在保留下游 CD226 共刺激訊號傳遞，以克服第一代抗 TIGIT 單株抗體的關鍵限制。在標準比較性體內模型中，HCB303 展現強效且協同的抗腫瘤活性。
HCB303 近期已獲美國 FDA 核准試驗中新藥申請（IND），得以啟動臨床開發。
HCB301（三特異性 SIRPα／PD-L1／TGF-β 捕捉蛋白）
HCB301 首次人體試驗的劑量遞增研究結果，於晚期實體腫瘤患者中展現作用機制的初步驗證，以及初步疾病穩定的觀察結果。
研究亦確認不同劑量所產生的生物學效應，並發現短暫性血小板減少症為與劑量相關、需關注的安全性因素。這些結果將作為後續藥物動力學／藥效學（PK/PD）模型分析、給藥時程優化及治療窗口調整的重要依據。
整體而言，HCB301 與 HCB303 的研發進展，展現漢康生技 FBDB™ 平台持續拓展至先天性與適應性免疫協同調控的應用潛力。
SITC 2026 研究發表資訊
- HCB101 平台工程設計與聯合治療策略
- 研究題目：CD47–SIRPα 工程設計與聯合治療開發
- 摘要編號：#578
- 發表日期：2026 年 11 月 6 日（星期五）
- HCB101 於復發性／轉移性頭頸部鱗狀細胞癌的研究
- 研究題目：HCB101 於頭頸部鱗狀細胞癌的持續性單藥治療活性，以及與 PD-1／EGFR 聯合治療的活性
- 摘要編號：#526
- 發表日期：2026 年 11 月 6 日（星期五）
- HCB301 第一期劑量遞增研究
- 研究題目：三特異性免疫調控療法於晚期實體腫瘤的首次人體研究
- 摘要編號：#565
- 發表日期：2026 年 11 月 7 日（星期六）
- HCB303 臨床前概念驗證研究
- 研究題目：三特異性 SIRPα／PD-L1／TIGIT 誘餌受體展現多類型免疫細胞活化作用
- 摘要編號：#399
- 發表日期：2026 年 11 月 7 日（星期六）
關於漢康生技
漢康生技（TWSE：7827）為全球臨床階段生技公司，透過專有的 Fc-Based Designer Biologics（FBDB™）平台，致力於開發新一代腫瘤免疫療法。藉由整合多重免疫路徑標靶及精準調控免疫效應功能，漢康生技開發創新療法，以克服腫瘤在先天性與適應性免疫路徑中的抗藥機制。
漢康生技於台北、美國舊金山灣區及上海設有營運據點，持續推進臨床及臨床前產品管線，開發針對難治型實體腫瘤及自體免疫疾病的多功能融合蛋白療法。
前瞻性聲明
本新聞稿包含有關漢康生技研究中產品、專有技術、臨床開發計畫、潛在治療應用及未來聯合治療策略之前瞻性聲明。此類聲明涉及科學、臨床、法規、營運及商業等方面的風險與不確定性。
初步臨床及臨床前研究結果未必能預測未來成果，且漢康生技研究中療法的安全性、有效性及額外臨床效益，尚未經充分對照的臨床試驗確立。實際結果及未來研發活動可能與目前預期存在重大差異。除適用法律另有規定外，漢康生技不承擔更新或修訂此類聲明的義務。