HanchorBio Reports Head and Neck Cancer Data for HCB101, Including Durable Monotherapy Activity and Complete Response at Low Dose in Combination with PD-1
Findings support HCB101 as a differentiated innate immune backbone in PD1-based regimens
[Taipei, Shanghai, San Francisco | April 22, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today reported updated clinical observations in head and neck squamous cell carcinoma (HNSCC) across both monotherapy and combination settings for HCB101, its rationally engineered SIRPα-Fc fusion protein functioning as an innate immune checkpoint blockade.
In the ongoing HCB101-101 Phase 1 monotherapy study, early evidence of clinical activity was observed in head and neck cancer, including a confirmed partial response with approximately 42% tumor reduction and durability beyond 65 weeks in a heavily pretreated patient, together with additional disease controls across dose levels. These findings provide initial clinical support for the biological activity of CD47–SIRPα blockade in this disease.
Complementing the monotherapy trial, an investigator-initiated study in Taiwan evaluated HCB101 in combination with pembrolizumab in recurrent/metastatic HNSCC (NCT07136545). As of the latest data cutoff, 3 patients were evaluable for efficacy at the 1.28 mg/kg low dose level, with the combination achieving a disease control rate (DCR) of 100%, including:
- 1 complete response (CR)
- 1 partial response (PR)
- 1 stable disease (SD)
The complete response was confirmed following subsequent assessment demonstrating regression of the target lymph node to <10 mm in short axis, with no residual non-target lesions or new lesions, consistent with RECIST 1.1 criteria. The patient had initially been assessed as a partial response, with tumor reduction over time before meeting criteria for a complete response. While based on small patient numbers and early follow-up, the observation of a complete response in combination with the standard-of-care, together with durable activity in monotherapy, provides a consistent signal supporting the role of CD47–SIRPα blockade in HNSCC.
“These findings reinforce how we think about HCB101—not as a standalone checkpoint inhibitor, but as a combination backbone that can integrate into and enhance existing standards of care,” said Scott Liu, PhD, Founder, Chairman, and Chief Executive Officer of HanchorBio. “The CD47–SIRPα axis is a central driver of myeloid immune suppression. By targeting this pathway, HCB101 has the potential to complement PD-1 therapy and help convert immune activation into more effective and sustained antitumor responses, particularly in diseases like HNSCC, where current treatments remain insufficient.”
Head and neck cancer remains a challenging disease in clinical practice, where PD-1-based therapies have improved outcomes but still deliver limited response rates and durability for many patients, particularly in the recurrent or metastatic setting. “What matters in HNSCC is not just where patients respond, but whether those responses are deep and durable,” commented Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (USA) of HanchorBio. “The monotherapy data give us confidence that the mechanism is active, and the early combination data suggest that this activity can be further enhanced. Even in this small dataset, we are seeing responses deepen over time in a sub-optimal dose, which is exactly the type of signal we would want from a therapy designed to engage innate immunity alongside PD-1 blockade.”
The HNSCC data are consistent with HanchorBio’s broader development strategy of advancing HCB101 across multiple combination settings, with second-line gastric cancer as the lead registrational path and head and neck cancer representing a key expansion opportunity where the molecule’s combination profile and mechanism may provide meaningful clinical differentiation.
About HCB101
HCB101 is HanchorBio’s next-generation SIRPα–IgG4 Fc fusion protein designed to block the CD47–SIRPα innate immune checkpoint while reducing the hematologic toxicities seen with earlier CD47-directed therapies. Engineered using the Company’s FBDB™ platform and AI-assisted (AlphaFold) structural modeling, HCB101 is intended to preserve macrophage-mediated antitumor activity while reducing red blood cell binding. Its emerging safety, receptor occupancy, and pharmacologic profile support development as monotherapy and in combination across multiple solid tumor settings, including those with established standard-of-care regimens. Ongoing clinical development includes gastric, colorectal, head and neck, and triple-negative breast cancers.
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.
漢康生技發布 HCB101 頭頸癌數據：單藥展現持久活性，低劑量聯合 PD-1 觀察到完全緩解
研究結果支持HCB101作為PD-1方案中具差異化的先天免疫骨幹療法
【台北、上海、舊金山｜2026年4月21日】——漢康生技（TPEx：7827）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，今日公布其工程化 SIRPα-Fc 融合蛋白 HCB101 於頭頸鱗狀細胞癌中的最新臨床觀察數據，涵蓋單一療法與聯合療法結果。
在進行中的 HCB101-101 一期單一療法研究中，頭頸癌佇列已觀察到早期臨床活性訊號，包括一例既往接受多線治療的患者達到部分緩解（PR），腫瘤縮小約42%，且緩解已持續超過65週；此外，各劑量組亦觀察到額外的疾病控制。這些發現為 CD47–SIRPα 阻斷機制在此疾病中的生物學活性提供了初步臨床支持。
作為單一療法試驗的補充，台灣一項研究者發起的臨床研究（IIT）評估了 HCB101 聯合帕博利珠單抗治療復發／轉移性頭頸鱗狀細胞癌的效果。截至最新數據截止日，在 1.28 mg/kg 低劑量水準下，共有3例患者可評估療效，聯合療法達到100%的疾病控制率，包括：
- 1例完全緩解（complete response, CR）
- 1例部分緩解（partial response, PR）
- 1例疾病穩定（stable disease, SD）
其中，該例完全緩解已於後續評估中獲得確認，目標淋巴結短徑縮小至 10 mm 以下，且無非靶病灶殘留，也未出現新發病灶，符合 RECIST 1.1 標準。該患者初始評估為部分緩解，其後腫瘤隨時間持續縮小，最終達到完全緩解標準。儘管目前患者數仍少、追蹤時間亦有限，但在標準治療聯合方案中觀察到完全緩解，加上單一療法所呈現的持久活性，為 CD47–SIRPα 阻斷在頭頸鱗狀細胞癌中的潛力提供了連貫且一致的臨床訊號支持。
「這些發現進一步強化了我們對 HCB101 的定位——它不只是單一檢查點抑制劑，而是能夠整合並增強現有標準治療的聯合骨幹療法，」漢康生技創辦人、董事長兼執行長劉世高博士表示，「CD47–SIRPα 通路是髓系免疫抑制的核心驅動因子。透過靶向這一通路，HCB101 有潛力補充 PD-1 療法，協助將免疫活化轉化為更有效、且更持久的抗腫瘤反應，尤其是在頭頸鱗狀細胞癌這類現有治療仍有未竟需求的疾病中。」
頭頸癌在臨床實務上仍是一項具挑戰性的疾病。儘管以 PD-1 為基礎的療法已改善治療結果，但對許多患者，尤其是復發或轉移性患者而言，反應率與反應持久性仍然有限。「在頭頸鱗狀細胞癌中，關鍵不僅在於患者是否產生反應，更在於這些反應能否進一步加深並維持，」漢康生技集團總裁兼醫療長、美國子公司執行長陸英明博士表示，「單一療法數據讓我們相信這一機制具備生物學活性，而早期聯合治療數據則進一步提示，這項活性有機會被放大。即使在目前這組小樣本數據中，我們仍觀察到低劑量下的反應會隨時間持續加深，這正是我們對一項旨在與 PD-1 阻斷協同活化先天免疫療法所期待看到的訊號。」
頭頸鱗狀細胞癌數據與漢康生技整體開發策略一致，公司正推進 HCB101 於多種聯合治療情境中的臨床布局，並以二線胃癌作為主要註冊路徑；同時，頭頸癌亦被視為重要的適應症拓展方向，HCB101 的聯合治療潛力與作用機制，預期可在此領域帶來具臨床意義的差異化表現。
關於 HCB101
HCB101 為漢康生技開發的新一代 SIRPα–IgG4 Fc 融合蛋白，旨在阻斷 CD47–SIRPα 先天免疫檢查點，同時降低早期 CD47 靶向療法所見的血液學毒性。HCB101 透過漢康生技專有 FBDB™ 平台，結合 AI 輔助（AlphaFold）結構建模進行設計，在保留巨噬細胞介導抗腫瘤活性的同時，降低與紅血球的結合。
目前所累積的安全性、受體佔有率及藥理特徵，支持 HCB101 作為單一療法及聯合療法持續開發，並拓展至多種實體腫瘤適應症，包括已有既定標準治療方案的疾病領域。HCB101 現正於胃癌、大腸直腸癌、頭頸癌及三陰性乳癌等適應症持續推進臨床開發。
綜合上述特性，HCB101 正被開發為具差異化優勢的先天免疫檢查點骨幹（Backbone）療法，並展現橫跨實體腫瘤與血液腫瘤的廣泛治療潛力。
關於漢康生技
漢康生技（股票代碼：7827.TPEx）是一家全球臨床階段的生物技術公司，專注於腫瘤免疫學及自體免疫疾病領域，研發總部設於台北，並在上海及美國舊金山灣區設有運營辦公室。公司由一支在生物藥發現與全球開發方面擁有豐富成功經驗的資深團隊領導，致力於重塑癌症治療格局。漢康生技專有的Fc基礎設計生物藥平台能夠開發具有多種靶向模式的多功能生物藥，旨在激活先天性與適應性免疫通路，以突破當前抗PD-1/L1免疫療法的局限。該平台已在多個體內腫瘤動物模型中成功獲得概念驗證數據。通過差異化的分子研發策略與可規模化的CMC工藝開發，漢康生技正推進一系列創新生物藥管線，致力於解決尚未被滿足的重大醫療需求。