HanchorBio Presents Two Oral Presentations at ESMO TAT Asia 2026 Highlighting Progress Across Its Next-Generation Immunotherapy Pipeline
Clinical data from HCB101 and first-in-human data from HCB301 support HanchorBio’s strategy to develop
multi-target immunotherapies addressing key mechanisms of tumor immune resistance
[Taipei, Shanghai, San Francisco | June 13, 2026] – HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced that two company-sponsored clinical programs were featured in oral presentations at the European Society for Medical Oncology Targeted Anticancer Therapies Asia Congress 2026, ESMO TAT Asia 2026, held in Hong Kong.
The presentations highlighted clinical and translational progress for HCB101, HanchorBio’s SIRPα-Fc innate checkpoint fusion protein targeting the CD47-SIRPα axis, and HCB301, a tri-specific SIRPα-PD-L1-TGF-β fusion protein designed to coordinate modulation of the SIRPα, PD-L1, and TGF-β pathways in a single molecule.
In the HCB101 oral presentation, based on a May 2026 data cutoff, updated Phase 1a monotherapy data from HCB101-101 (NCT05892718) showed that 67 patients had been treated at doses ranging from 0.08 mg/kg to 36 mg/kg without reaching the maximum tolerated dose. Two dose-limiting toxicities of thrombocytopenia were observed, one Grade 3 at 2.56 mg/kg and one Grade 4 at 36 mg/kg, with no bleeding events reported. Treatment-related adverse events were predominantly Grade 1–2, with one Grade 3 anemia event and no cumulative anemia or febrile neutropenia signal observed. HCB101 also demonstrated linear pharmacokinetics and sustained CD47 receptor occupancy of ≥90% at doses ≥8 mg/kg. Preliminary antitumor activity was observed in this heavily pretreated population (median of 3 prior lines of treatment), including two confirmed partial responses: one in head and neck squamous cell carcinoma (with ~42% tumor reduction and ongoing response beyond 69 weeks), and one in marginal zone lymphoma (with ~89% metabolic reduction at Week 16). Eleven additional patients achieved durable stable disease across multiple tumor types.
The accepted HCB101 abstract also reported combination dose-escalation data from HCB101-201, a Phase 1b/2 multi-cohort combination study (NCT06771622), including activity in second-line gastric cancer and first-line HER2-positive gastric cancer. In second-line gastric cancer, 15 efficacy-evaluable patients achieved an overall response rate of 60% across 2.56–12 mg/kg, while the 5.12–8 mg/kg mid-dose cohorts achieved an ORR of 80%, with maximal tumor regression of 78.2% and ongoing responses beyond 36 weeks. In 1L HER2-positive gastric cancer, 5 efficacy-evaluable patients achieved an ORR of 80% (4/5) and a disease control rate of 100%. Anti-tumor activity was also observed in additional Phase 1b/2 cohorts, including PD-1-based combinations.
“Having two oral presentations at ESMO TAT Asia is an important recognition of the clinical progress we are making across our immune-modulation platform,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “The HCB101 data continue to support a differentiated therapeutic window for CD47-SIRPα inhibition, while the first-in-human HCB301 data show that coordinated multi-pathway immune modulations can be translated into the clinic.”
In the HCB301 oral presentation, first-in-human Phase 1 data supported the clinical feasibility of the tri-specific immune modulation across the SIRPα, PD-L1, and TGF-β pathways. Among 21 patients enrolled across early dose levels, HCB301 demonstrated a manageable safety profile, predominantly low-grade and reversible hematologic events, and early disease stabilization in heavily pretreated patients with advanced solid tumors. These early data support continued dose escalation to further evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
“Together, these presentations highlight the progress of our clinical pipeline and the breadth of our immune-modulation strategy,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “HCB101 provides clinical evidence supporting differentiated CD47–SIRPα inhibition, while HCB301 extends our approach into coordinated multi-pathway immune modulations. We believe these programs strategically and uniquely position HanchorBio to address a wide variety of tumors where innate and adaptive immune resistances, and suppressive tumor microenvironment all play important roles.”
HanchorBio plans to continue advancing HCB101 across monotherapy and combination settings, with a focus on tumor types in which myeloid-driven immune suppression may contribute to treatment resistance. The Company’s biology-based approach is supported by preclinical data across more than 80 tumor models in animals and emerging clinical data from HCB101. HCB301 will continue dose escalation to further evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
About HanchorBio
Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TWSE: 7827) 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2026 ESMO靶向抗癌治療亞洲大會發表兩場口頭報告，展現下一代免疫療法臨床進展
HCB101 臨床數據與 HCB301 首次人體試驗數據，支持漢康生技開發多靶點免疫療法，以因應腫瘤免疫抗性關鍵機制
漢康生技（TWSE: 7827），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技公司，今日宣布，公司兩項臨床開發計畫於 2026 ESMO 靶向抗癌治療亞洲大會獲選為口頭報告，該會議於香港舉行。
本次發表聚焦於 HCB101 與 HCB301 的臨床及轉譯醫學進展。HCB101 為漢康生技針對 CD47-SIRPα 軸所開發之 SIRPα-Fc 先天免疫檢查點融合蛋白；HCB301 則為三特異性 SIRPα-PD-L1-TGF-β 融合蛋白，設計目的為於單一分子中協同調控 SIRPα、PD-L1 與 TGF-β 三大免疫相關路徑。
在 HCB101 口頭報告中，根據 2026 年 5 月數據截止日，HCB101-101（NCT05892718）Phase 1a 單藥治療更新數據顯示，共 67 名患者接受 0.08 mg/kg 至 36 mg/kg 劑量治療，尚未達到最大耐受劑量。試驗中觀察到兩例血小板減少之劑量限制毒性，分別為 2.56 mg/kg 劑量組之一例 Grade 3 事件，以及 36 mg/kg 劑量組之一例 Grade 4 事件，且未通報出血事件。治療相關不良事件多為 Grade 1–2，僅觀察到一例 Grade 3 貧血事件，未見累積性貧血或發熱性嗜中性白血球低下訊號。HCB101 亦展現線性藥物動力學特徵，並於 ≥8 mg/kg 劑量下維持 ≥90% 的 CD47 受體佔有率。
在高度經治療族群中，HCB101 觀察到初步抗腫瘤活性，該族群先前治療線別中位數為三線。其中包括兩例確認部分緩解：一例為頭頸部鱗狀細胞癌，腫瘤縮小約 42%，且療效持續超過 69 週；另一例為邊緣區淋巴瘤，於第 16 週觀察到約 89% 代謝縮減。此外，另有 11 名患者於多種腫瘤類型中達到持久穩定疾病。
獲接受之 HCB101 摘要亦報告 HCB101-201（NCT06771622）Phase 1b/2 多隊列合併治療研究之劑量遞增數據，涵蓋二線胃癌與一線 HER2 陽性胃癌。在二線胃癌中，15 名可評估療效患者於 2.56–12 mg/kg 劑量範圍內達到 60% 整體反應率；其中 5.12–8 mg/kg 中劑量組整體反應率達 80%，最大腫瘤縮小幅度為 78.2%，且療效持續超過 36 週。在一線 HER2 陽性胃癌中，5 名可評估療效患者達到 80%（4/5）整體反應率與 100% 疾病控制率。其他 Phase 1b/2 隊列，包括以 PD-1 為基礎的合併治療，也觀察到抗腫瘤活性。
「能於 ESMO TAT Asia 獲選兩場口頭報告，是對漢康生技免疫調控平台臨床進展的重要肯定，」漢康生技創辦人、董事長暨執行長劉世高博士表示。「HCB101 數據持續支持其在 CD47-SIRPα 抑制領域具差異化治療窗口的潛力；而 HCB301 首次人體試驗數據則顯示，協同多路徑免疫調控策略具備轉化至臨床開發的可行性。」
在 HCB301 口頭報告中，首次人體 Phase 1 數據支持其跨 SIRPα、PD-L1 與 TGF-β 路徑之三特異性免疫調控策略的臨床可行性。於早期劑量組共 21 名受試患者中，HCB301 展現可管理之安全性特徵，不良事件主要為低級別且可逆之血液學事件，並於高度經治療之晚期實體腫瘤患者中觀察到早期疾病穩定訊號。這些早期數據支持 HCB301 持續進行劑量遞增，以進一步評估安全性、藥物動力學、藥效學及初步抗腫瘤活性。
「整體而言，本次兩場發表展現漢康生技臨床管線的推進，以及公司免疫調控策略的廣度，」漢康生技總裁暨集團醫療長、美國執行長陸英明博士表示。「HCB101 提供支持差異化 CD47-SIRPα 抑制策略的臨床證據，而 HCB301 則將我們的平台延伸至協同多路徑免疫調控。我們相信，這些計畫將使漢康生技能以具策略性且具差異化的方式，布局多種腫瘤治療情境，特別是在先天免疫、後天免疫抗性與免疫抑制性腫瘤微環境皆扮演關鍵角色的領域。」
漢康生技將持續推進 HCB101 於單藥及合併治療情境中的臨床開發，並聚焦於髓系細胞驅動之免疫抑制可能導致治療抗性的腫瘤類型。公司以生物學機制為基礎的開發策略，受到超過 80 種動物腫瘤模型之臨床前數據，以及 HCB101 新興臨床數據所支持。HCB301 則將持續進行劑量遞增，以進一步評估安全性、藥物動力學、藥效學及初步抗腫瘤活性。
關於漢康生技
漢康生技（TWSE: 7827）據點涵蓋台北、上海及舊金山灣區，是一家專注於腫瘤免疫與免疫相關疾病的全球臨床階段生物科技公司。公司由具備生物藥發現與全球開發經驗的團隊領導，致力於重塑癌症治療格局。漢康生技專有 Fc-based designer biologics（FBDB™）平台可設計具多功能與多元靶向模式之生物製劑，旨在同時活化先天與後天免疫路徑，並克服現有 anti-PD1/L1 免疫療法所面臨的挑戰。FBDB™ 平台已於多項體內腫瘤動物模型中取得概念驗證數據。漢康生技正推進一系列創新生物藥管線，透過差異化分子設計與可擴展 CMC 策略，回應重大未滿足醫療需求。
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、法規策略及未來計畫之前瞻性聲明。實際結果可能因多項風險與不確定性而與前瞻性聲明所明示或暗示者有重大差異，包括臨床開發結果、法規審查決定及市場環境等。除適用法律另有規定外，漢康生技無義務更新任何前瞻性聲明。