HanchorBio Presents First Dedicated HCB101 Head and Neck Cancer Data in Oral Presentation at ICHNO 2026
Oral presentation marks the first HNSCC-focused clinical disclosure for HCB101 and underscores the indication’s strategic relevance for innate immune checkpoint development
[Taipei, Shanghai, San Francisco | March 20, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the first dedicated presentation of HCB101 clinical data in head and neck squamous cell carcinoma (HNSCC) in an oral presentation at ICHNO 2026 (the 10th International Congress on Innovative Approaches in Head and Neck Oncology), a joint ESTRO, EHNS, and ESMO congress, in Seville, Spain.
This first HNSCC-focused disclosure brings together an emerging monotherapy and a combination strategy for HCB101 in solid tumors, where clinical progress has been limited, and durable benefit remains difficult to achieve for many patients. The data presented support continued evaluation of HCB101 in HNSCC by showing early signs of antitumor activity and durability, while reinforcing the importance of CD47–SIRPα blockade in a disease characterized by persistent immune escape and substantial unmet need after current standard therapies.
The presentation highlighted emerging clinical findings from the ongoing HCB101-101 Phase 1a monotherapy study (NCT05892718), together with supportive early observations from an investigator-initiated study (SirH&N) in Taiwan. Taken together, these data reinforces the potential relevance of CD47-SIRPα blockade in HNSCC, a disease characterized by persistent immune escape, myeloid-driven immunosuppression, and substantial unmet medical need after current standard therapies.
“Head and neck cancer is exactly the kind of indication where biological mechanism, unmet medical need, and development practicality come together,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “With HCB101, we used AlphaFold-guided structural modeling within our FBDB™ platform to redesign the SIRPα molecule to enhance and sustain receptor occupancy while reducing the hematologic liability that limited earlier anti-CD47 molecules and restricted their use in combination with standard therapies. That differentiation is especially important in HNSCC, where PD-1 therapy has become an established standard of care, yet meaningful clinical response and durable benefit remain limited for many patients. We believe HCB101 is particularly relevant in this setting because CD47-SIRPα blockade addresses the myeloid component of immune resistance that PD-1 alone does not fully overcome. This provides a strong mechanistic rationale for combining HCB101 with PD-1 inhibitors to deepen and prolong adaptive immune responses, and with cetuximab to amplify macrophage-mediated antibody-dependent cellular phagocytosis (ADCP) through anti-EGFR-directed tumor opsonization.”
Presentation Details:
Presentation ID: 401
Title: First Durable Clinical Response to CD47-SIRPα Blockade in Head and Neck Squamous Cell Carcinoma: Results from the HCB101 Phase 1 Trial
Session Name / Location: New Approaches to Treatment / Palacio de Congresos y Exposiciones de Sevilla
Date / Time: 20 March 2026 / 15:15 – 16:15 CET
Key HNSCC Findings Presented at ICHNO 2026
The oral presentation highlighted emerging evidence of clinical activity and durability for HCB101 in HNSCC across both monotherapy and combination settings:
- In HCB101-101 Phase 1a monotherapy study (NCT05892718), one heavily pretreated HNSCC patient achieved a confirmed partial response (PR) with ~42% tumor reduction and durability beyond 53 weeks.
- Additional disease control was observed in head and neck cancer cohorts.
- Pharmacodynamic analyses showed sustained CD47 receptor occupancy, including near-complete receptor occupancy early after dosing in the responding HNSCC patient, supporting on-target pharmacodynamic activity.
- In a Taiwan IIT study (SirH&N), the first 3 recurrent/metastatic HNSCC patients treated with HCB101 plus pembrolizumab achieved 2 confirmed PRs (≥20 weeks durability) and 1 SD
- This corresponded to an ORR of 66.7% and a DCR of 100% in the small evaluable cohort.
- Best tumor shrinkage in the SirH&B study reached 68.1% at 1.28 mg/kg
The oral presentation also highlights why HNSCC may represent a strategically important development setting for HCB101. In addition to the underlying scientific rationale, HNSCC offers a well-established treatment framework that incorporates both checkpoint inhibitors and EGFR-directed therapy, supporting the development of these combinations. HanchorBio’s ongoing Phase 1b/2a studies include HNSCC cohorts evaluating HCB101 in combination with pembrolizumab and with cetuximab-containing regimens, consistent with the Company’s view that HCB101 may serve as an innate immune backbone that can be integrated into established standards of care.
“HNSCC remains a difficult disease in clinical practice because even when patients respond to PD-1-based therapy, durability is often limited and relapse can occur quickly,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “That is why these early HCB101 findings are meaningful. What is particularly encouraging is that we are seeing not only antitumor activity and early signs of durability, but also sustained receptor occupancy consistent with target engagement. Even in the small Taiwan combination experience generated at a sub-therapeutic HCB101 dose, we observed confirmed responses and meaningful tumor shrinkage. These data are preliminary and based on very small numbers, but they compare favorably with historical expectations in HNSCC and support continued development of HCB101 in this setting.”
About HCB101: A Next-Generation SIRPα Fc-Fusion Protein
HCB101 is a rationally engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB™ platform to selectively block the CD47–SIRPα innate immune checkpoint while minimizing hematologic toxicity. Unlike earlier anti-CD47 approaches, HCB101 is designed to preserve macrophage-mediated antitumor activity while reducing red blood cell binding, a limitation that historically constrained CD47-directed therapies.
Engineered using AI-assisted structural modeling, HCB101 is designed to achieve differentiated binding to CD47 on tumor cells while maintaining low affinity for CD47 on red blood cells. Its safety, receptor occupancy, and pharmacologic characteristics are intended to support development both as monotherapy and in combination with established oncology regimens without disrupting standard dosing or clinical workflows.
In ongoing clinical and translational evaluation, HCB101 has demonstrated sustained target engagement and early antitumor activity across monotherapy and combination settings, including in tumor types historically challenging for CD47-directed therapies. Dose escalation and Phase 2 expansion cohorts in gastric, colorectal, head-and-neck, and triple-negative breast cancers are ongoing.
These attributes support HCB101’s development as a differentiated innate immune checkpoint backbone with broad potential across solid tumors and hematologic malignancies.
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. For more information, please visit: https://www.HanchorBio.com
*Please note that the World Oncology Congress (WOC), originally scheduled for March 23-25, 2026, has been rescheduled to August 17-19, 2026. For further information, please visit: https://www.cancer-congress.org/scientific-information
漢康生技於2026 ESMO頭頸癌年會首次以口頭發表 HCB101 頭頸癌臨床數據
漢康首次聚焦頭頸鱗狀細胞癌（HNSCC）
的臨床數據發表，凸顯該適應症在先天免疫檢查點開發中的策略重要性
漢康生技為一家致力於開發次世代免疫療法、聚焦腫瘤與自體免疫疾病的全球臨床階段生技公司，今日宣布於 ICHNO 2026（頭頸癌年會）以口頭首次發表 HCB101 在頭頸鱗狀細胞癌（HNSCC）的臨床數據。該大會由 ESTRO（歐洲放射治療與腫瘤學大會）、EHNS（歐洲頭頸學會） 與 ESMO （歐洲腫瘤內科學會）聯合主辦，於西班牙塞維利亞舉行。
此次針對 HNSCC 的首次臨床數據揭露，整合了 HCB101 在實體腫瘤中的單藥與聯合治療策略。此類腫瘤臨床進展有限，多數患者仍難以獲得持久的療效。不過在此次發表的數據顯示，HCB101 不僅展現初步抗腫瘤活性與持久性潛力，也進一步支持 CD47–SIRPα 阻斷機制在具持續免疫逃脫特性的疾病中具有重要的治療意義。
本次發表重點包括正在進行的 HCB101-101 第 1a 期單藥試驗（NCT05892718）之臨床結果，以及台灣一項研究者發起的臨床研究（IIT）（SirH&N）之早期觀察數據。整體而言，這些結果支持 CD47-SIRPα 阻斷在頭頸癌中的潛在臨床價值。該疾病特徵包括持續免疫逃脫、髓系免疫抑制，以及現行標準治療後仍存在重大未滿足需求。
漢康生技創辦人、董事長暨執行長劉世高博士表示：「頭頸癌正是一個在生物機制、未滿足醫療需求與開發可行性上高度契合的適應症。透過 HCB101，我們運用 FBDB™ 平台結合 AlphaFold 引導的結構建模，重新設計 SIRPα 分子，藉以提升並維持受體占有率的同時，降低過去 anti-CD47 分子所帶來的血液學毒性，這些問題曾限制其與標準療法的聯用。這項差異在頭頸癌特別重要，因為 PD-1 治療已成為標準療法，但臨床反應與持久性仍有限。我們認為 HCB101 在此具有高度潛力，因為 CD47-SIRPα 阻斷可針對 PD-1 無法完全克服的髓系免疫抗性，提供強而有力的機制基礎，使其可與 PD-1 抑制劑聯用以加深並延長適應性免疫反應，亦可與 cetuximab 併用，透過抗 EGFR 的腫瘤調理作用增強巨噬細胞介導的抗體依賴性細胞吞噬作用（ADCP）。」
發表資訊：
- 發表編號：401
- 標題：First Durable Clinical Response to CD47-SIRPα Blockade in Head and Neck Squamous Cell Carcinoma: Results from the HCB101 Phase 1 Trial
- 場次／地點：New Approaches to Treatment / Palacio de Congresos y Exposiciones de Sevilla
- 日期／時間：2026 年 3 月 20 日 / 15:15 – 16:15 CET
ICHNO 2026 發表之頭頸癌重要數據
本次口頭報告呈現 HCB101 在頭頸癌單藥與聯合治療中的初步臨床活性與持久性證據：
- 在 HCB101-101 第 1a 期單藥試驗中，一位經多線治療後的頭頸癌患者達到確認部分緩解（PR），腫瘤直徑縮小約 42%，且持續超過 53 週
- 其他頭頸癌患者群中亦觀察到疾病控制效果
- 藥效動力學分析顯示 CD47 受體占有率持續維持，在該反應患者中於給藥早期即接近完全占有，支持其標靶作用
- 在台灣 SirH&N 研究者發起的臨床研究（IIT）中，首批 3 位復發／轉移性頭頸癌患者接受 HCB101 聯合 pembrolizumab 治療，其中 2 位達確認 PR（持續 ≥20 週），1 位為疾病穩定（SD）
- 在此小型可評估族群中，客觀反應率（ORR）為 66.7%，疾病控制率（DCR）為 100%
- SirH&N 研究中最佳腫瘤縮小達 68.1%（劑量 1.28 mg/kg）
本次發表亦指出頭頸癌為 HCB101 具有策略價值的重要開發適應症。除科學機制外，頭頸癌已具備成熟治療架構，涵蓋免疫檢查點抑制劑與 EGFR 標靶治療，有利於聯合療法開發。漢康生技目前進行中的 1b/2a 試驗亦納入頭頸癌族群，評估 HCB101 與 pembrolizumab 及含 cetuximab 治療的聯合方案，符合公司將 HCB101 作為可整合進既有標準治療之先天免疫骨幹療法的策略。
漢康生技集團總裁暨全球醫療長、同時擔任美國執行長的陸英明博士表示：「在臨床上，頭頸癌仍是一項具有挑戰的疾病，即使患者對 PD-1 治療產生反應，其持久性通常有限且容易復發。因此，這些 HCB101 的初步結果具有重要意義。令人鼓舞的是，我們不僅觀察到抗腫瘤活性與早期持久性，也看到與標靶作用一致的持續受體占有率。即使在台灣聯合治療研究中使用低於治療劑量的 HCB101，仍觀察到確認反應與顯著腫瘤縮小。雖然這些數據仍屬初步且樣本數有限，但與 HNSCC 的歷史數據相比表現具競爭力，並支持持續開發 HCB101。」
關於 HCB101：次世代 SIRPα Fc 融合蛋白
HCB101 為透過漢康生技 FBDB™ 平台理性設計的 SIRPα–IgG4 Fc 融合蛋白，可選擇性阻斷 CD47–SIRPα 先天免疫檢查點，同時降低血液學毒性。相較於早期 anti-CD47 療法，HCB101 在保留巨噬細胞抗腫瘤活性的同時，降低對紅血球的結合能力，克服過去 CD47 療法的主要限制。
HCB101 採用 AI 輔助結構建模設計，使其對腫瘤細胞 CD47 具有差異化結合能力，同時對紅血球 CD47 保持低親和力。其安全性、受體占有率與藥理特性，使其可作為單藥或與既有腫瘤治療方案聯用，且不影響既有給藥流程。
在目前臨床與轉譯研究中，HCB101 已顯示持續標靶作用與初步抗腫瘤活性，涵蓋單藥與聯合治療，並包括過去 CD47 療法較具挑戰的腫瘤類型。目前正進行劑量遞增與第二期擴展試驗，涵蓋胃癌、大腸直腸癌、頭頸癌與三陰性乳癌。
這些特性支持 HCB101 作為具差異化的先天免疫檢查點骨幹療法，具備跨實體腫瘤與血液腫瘤的廣泛潛力。
關於漢康生技
漢康生技（7827.TPEx）總部位於台北，並於上海與舊金山灣區設有據點，是一家全球臨床階段生技公司，專注於腫瘤免疫與免疫相關疾病。公司由具備生物製劑研發與全球開發經驗的團隊領導，致力於改變癌症治療格局。
其專有 FBDB™ 平台可設計多功能生物製劑，透過多重靶點機制同時活化先天與適應性免疫，突破現有 anti-PD1/L1 免疫療法的限制。該平台已於多項體內腫瘤模型中取得概念驗證成果。
漢康生技正推進多項創新生物藥產品組合，透過差異化分子設計與可擴展製程，滿足重大未被滿足的醫療需求。
*請留意：原訂於2026年3月23日至25日舉行的世界腫瘤大會（World Oncology Congress, WOC），已改期至2026年8月17日至19日舉行。更多資訊請參閱：https://www.cancer-congress.org/scientific-information