HanchorBio Highlights Advancing HCB101 Clinical Program Across Monotherapy and Combination Settings at ESMO-TAT 2026
Phase 1 data demonstrate sustained CD47 target engagement, differentiated safety, and encouraging clinical activity supporting HCB101 as an innate immune checkpoint backbone
[Taipei, Shanghai, San Francisco | March 16, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the presentation of updated clinical data for HCB101 at the ESMO Targeted Anticancer Therapies (TAT) Congress 2026 in Paris, France.
Data were presented from the ongoing HCB101-101 Phase 1a monotherapy study (NCT05892718) in an oral session, as well as from the HCB101-201 Phase 1b/2a combination study (NCT06771622) in a poster presentation. Collectively, these findings reinforce HCB101’s differentiated safety profile, sustained CD47 receptor occupancy, and early evidence of antitumor activity across multiple tumor types, especially in combination with established standard-of-care therapies.
HCB101 has recently been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of gastric cancer.
“The CD47 field did not encounter setbacks because the biology was flawed — it stalled because an adequate therapeutic window was not observed due to the lack of structurally engineered SIRPα with differential binding activities,” said Scott Liu, PhD, Founder, Chairman, and CEO of HanchorBio. “Early anti-CD47 antibodies showed biological activity but were limited by hematologic toxicity. Fc-fusion approaches improved tolerability, yet precise calibration of effector function and enhanced target engagement were not achieved. With HCB101, we used AlphaFold-guided structural modeling within our FBDB™ platform to deliberately redesign the SIRPα with desired binding properties while preserving Fc functionality. The objective was clear: sustained high-affinity receptor occupancy without reintroducing the hematologic liability that constrained prior molecules. The Phase 1 data now demonstrate that this balance is achievable. Importantly, HCB101 serves as the molecular foundation for our next-generation multi-functional checkpoint programs, including HCB301.”
Presentation Details:
Presentation ID: 610
Title: First-in-Human Phase 1 Evaluation of HCB101, a SIRPα-Fc Innate Checkpoint Fusion Protein: Safety, Pharmacokinetics, and Receptor Occupancy
Session Name / Location: Proffered Paper session / Auditorium Bordeaux, Palais des Congrès
Date / Time: 16 March 2026 / 16:00 – 17:30 CET
Presentation ID: 66P
Title: Early Safety, Pharmacokinetics, and Translational Profiling of HCB101 in Combination with Standard-of-Care Regimens: Results from the Phase 1b/2a HCB101-201 Study
Session Name / Location: Poster Display session / Foyer, Palais des Congrès
Date / Time: 16 March 2026 / 17:30 – 18:30 CET
Oral Presentation: HCB101-101 Phase 1a Monotherapy
As of the February 2026 data cutoff:
- 67 patients enrolled across 13 dose levels (0.08 – 36 mg/kg QW)
- Maximum tolerated dose not reached
- Predominantly Grade 1-2 treatment-related adverse events
- Two dose-limiting toxicities (thrombocytopenia): Grade 3 at 2.56 mg/kg and Grade 4 at 36 mg/kg; both resolved
- Linear pharmacokinetics (t1/2 ~3 days)
- Sustained CD47 receptor occupancy >99% at ≥8 mg/kg
Confirmed Clinical Activity:
- Confirmed PR in HNSCC (~42% tumor reduction, ≥40 weeks durability)
- Confirmed PR in marginal zone lymphoma (~89% tumor reduction, ≥16 weeks durability)
- Ten durable stable disease (≥4-9 months) observed across multiple solid tumors
These findings demonstrate a broad therapeutic window and sustained target engagement without the classical hematologic toxicities historically associated with CD47 blockade
Poster Presentation: HCB101-201 Combination Study
HCB101 is being evaluated across multiple established oncology regimens, including chemotherapy, PD-1 inhibitors, anti-VEGF, HER2-targeted, and EGFR-directed therapies. Across combination cohorts:
- Well tolerated across gastric cancer (GC), TNBC, CRC, and HNSCC
- No unexpected overlapping toxicities
- Cytopenias primarily attributable to chemotherapy
- No additive hematologic safety signal observed
Selected Highlights:
Second-line Gastric Cancer (Ramucirumab + Paclitaxel): (n=15)
- Overall ORR: 60% (9/15); DCR 100% (15/15)
- Mid-dose ORR: 100% (5.12 mg/kg), 81% (8 mg/kg)
- Dose-level mean tumor shrinkage: -6.0% (2.56 mg/kg), -33.4% (5.12 mg/kg), -46.0% (8 mg/kg), -27.9% (12 mg/kg, ongoing)
- Dose-dependent tumor shrinkage, with deepest reduction up to -78.2%
First-line HER2+ Gastric Cancer: (n=5)
- Overall ORR: 80% (4/5); DCR 100% (5/5)
- Mean tumor shrinkage: -46.6%% (5.12 mg/kg) and -29.0% (8 mg/kg)
- No DLT; no HCB101-related SAEs
First-line TNBC: (n=7)
- Overall ORR: 42.9% (3/7); DCR 100% (7/7)
- Dose-level ORR: 33% (2.56 mg/kg) and 67% (8 mg/kg)
- Mean tumor shrinkage: -28.4%% (2.56 mg/kg) and -48.4% (8 mg/kg)
- No DLTs; no new overlapping toxicities
These results support the continued development of HCB101 as a macrophage checkpoint backbone that can be integrated into standard-of-care regimens without compromising safety or clinical workflow.
Two HCB101 abstracts were accepted at ESMO-TAT 2026, including an oral presentation and a poster, reflecting strong peer-review recognition of the program’s translational relevance.
“The scientific dialogue at ESMO-TAT was rigorous and highly engaged, with extensive discussion around exposure-response relationships and hematologic differentiation relative to prior CD47 programs,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “Following the oral presentation, much of the discussion centered on whether sustained receptor occupancy could be achieved without cumulative anemia signal – the central question that has historically constrained this field. In monotherapy, we demonstrated durable target engagement at biologically active exposures without a cumulative hematologic liability. At the combination poster, there was significant interest in the 2L gastric cancer data, particularly the dose-dependent activity observed without additive cytopenia. That consistency across settings reinforces our confidence that HCB101 can function as a true innate immune backbone rather than a single-line opportunity. Collectively, these data provide a strong translational foundation for Phase 2 expansion.”
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 achieves 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 designed to enable integration 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 as both monotherapy and in combination, including in tumor types historically challenging for CD47-directed therapies. Dose escalation and Phase 2 expansion cohorts in gastric, colorectal, and head-and-neck 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.
漢康生技於 ESMO標靶抗癌治療大會公布 HCB101 單藥與聯合治療臨床進展，展現作為先天免疫檢查點治療骨幹的潛力
漢康生技為全球臨床階段生技公司，專注於開發腫瘤與自體免疫疾病的次世代免疫療法。在 2026 年 ESMO標靶抗癌治療大會（ESMO Targeted Anticancer Therapies Congress）上發表 HCB101 最新臨床數據，涵蓋單藥治療與聯合標準療法兩大臨床研究，進一步支持 HCB101 在安全性、持續維持 CD47 受體佔有率，以及初步抗腫瘤活性上的差異化優勢。此次會議於法國巴黎舉行，漢康生技以口頭報告與海報發表形式，展示 HCB101 作為新一代先天免疫檢查點療法骨幹的發展潛力。
本次發表內容包括持續進行中的 HCB101-101 Phase 1a 單藥研究（NCT05892718）口頭報告，以及 HCB101-201 Phase 1b/2a 聯合治療研究（NCT06771622）海報發表。整體結果顯示，HCB101 不僅具備穩定的 CD47 受體佔有表現，也在多種腫瘤類型中展現令人鼓舞的臨床活性，尤其於聯合標準療法時更顯潛力。HCB101 於上個月亦已獲得美國食品藥物管理局（FDA）授予胃癌治療之孤兒藥資格認定。
漢康生技創辦人、董事長暨執行長劉世高博士表示：「CD47 領域過去遭遇挑戰，並非因其作用機制無效，而是因為早期分子設計未能建立足夠的治療窗。HCB101 是我們透過 FBDB™ 平台，結合 AlphaFold 引導進行結構建模，重新優化 SIRPα 分子設計的結果，藉此達到理想的結合特性，同時保留抗體 Fc 功能。我們的目標很明確：就是在不重蹈過去血液學毒性問題的前提下，實現持續且良好的受體佔有。第一期臨床數據也證明，這樣的設計方向是可行的。」
活動資訊
活動名稱： ESMO標靶抗癌治療大會
日期： 2026 年 3 月 16 日
地點： 法國巴黎 Palais des Congrès
發表形式： 口頭報告與海報發表
發表重點
- 口頭報告：HCB101-101 Phase 1a 單藥研究
截至 2026 年 2 月資料截止日，HCB101-101 研究共納入 67 位患者，涵蓋 13 個劑量層級（0.08–36 mg/kg，每週一次）。研究結果顯示，最大耐受劑量（MTD）尚未達到，治療相關不良事件多為第 1 至 2 級。研究中觀察到兩例劑量限制毒性（DLT），皆為血小板減少症，分別發生於 2.56 mg/kg 的第 3 級與 36 mg/kg 的第 4 級，且皆已恢復。藥物動力學呈線性，半衰期約為 3 天；在劑量達 8 mg/kg 以上時，CD47 受體佔有率可持續維持超過 99%。
臨床活性方面，研究中觀察到頭頸部鱗狀細胞癌（HNSCC）患者確認部分緩解（PR），腫瘤直徑縮小約 42%，療效持續超過 40 週；另有一位邊緣區淋巴瘤患者達確認 PR，腫瘤直徑縮小約 89%，療效持續超過 16 週。此外，也在多種實體腫瘤中觀察到 10 例持久穩定疾病（durable stable disease），持續時間約 4 至 9 個月。整體結果顯示，HCB101 在不引發過往 CD47 阻斷療法常見血液學毒性的情況下，具備廣泛治療窗與持續靶點結合能力。
- 海報發表：HCB101-201 Phase 1b/2a 聯合治療研究
HCB101 目前正與多種既有腫瘤標準療法進行聯合評估，包括化療、PD-1 抑制劑、抗 VEGF、HER2 標靶以及 EGFR 導向療法。整體聯合治療隊列結果顯示，HCB101 於胃癌（GC）、三陰性乳癌（TNBC）、大腸直腸癌（CRC）與頭頸癌（HNSCC）中皆具良好耐受性，未觀察到非預期的重疊毒性；出現的細胞減少現象主要歸因於化療，未見額外血液學安全性風險。
在二線胃癌患者中，HCB101 與 ramucirumab 加 paclitaxel 聯合治療（n=15）顯示整體客觀反應率（ORR）為 60%，疾病控制率（DCR）達 100%。其中，中劑量組表現尤其突出，5.12 mg/kg 組 客觀反應率ORR 達 100%，8 mg/kg 組為 81%。各劑量層級平均腫瘤縮小幅度呈現劑量相關趨勢，最高可達 -78.2%。
在一線 HER2 陽性胃癌患者中（n=5），整體客觀反應率 ORR 為 80%，DCR 為 100%，且未出現 DLT 或與 HCB101 相關的嚴重不良事件（SAE）。在一線三陰性乳癌患者中（n=7），整體客觀反應率 ORR 為 42.9%，DCR 同樣達 100%；不同劑量組亦呈現活性提升趨勢，且未見新的重疊毒性。上述結果支持 HCB101 作為巨噬細胞檢查點治療骨幹，具備整合至既有標準療法且不影響安全性與臨床流程的潛力。
學術交流與臨床意義
本次 ESMO標靶抗癌治療大會共接受兩篇 HCB101 摘要，分別為一場口頭報告與一篇海報發表，顯示該計畫在轉譯醫學與臨床開發上的高度關注與認可。漢康生技總裁暨醫療長暨美國漢康公司執行長陸英明博士表示，會中討論聚焦於暴露量與反應關係，以及 HCB101 與先前 CD47 計畫相比之血液學差異化特性。單藥研究證明，HCB101 可在具生物活性的暴露條件下維持持續受體佔有，且未出現累積性貧血訊號；而在聯合治療研究中，二線胃癌數據與未增加細胞減少風險的結果，也引發高度關注。整體而言，這些數據為後續臨床二期擴展奠定了強而有力的轉譯基礎。
關於 HCB101
HCB101 為漢康生技以 FBDB™ 平台理性設計開發之 SIRPα–IgG4 Fc 融合蛋白，旨在選擇性阻斷 CD47–SIRPα 先天免疫檢查點，同時降低血液學毒性。不同於早期的抗 CD47，HCB101 在保留巨噬細胞介導抗腫瘤活性的同時，降低對紅血球 CD47 的結合能力，以克服過去限制該療法發展的關鍵挑戰。
透過 AI 輔助結構建模，HCB101 對腫瘤細胞上的 CD47 具差異化結合特性，並維持對紅血球 CD47 的低親和力。其安全性、受體佔有率與藥理特性，皆有利於與既有腫瘤治療方案整合。目前 HCB101 正於胃癌、大腸直腸癌及頭頸癌等適應症持續進行劑量遞增與臨床二期擴展研究。
綜合上述特質，HCB101 已定位為具備差異化的先天免疫檢查點骨幹（Backbone），並具備橫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（證券代碼：7827.TPEx）總部位於台北、上海與舊金山灣區，是一家全球臨床階段生技公司，專注於腫瘤免疫治療與免疫相關疾病新藥開發。公司由具備生物藥研發與全球開發實績的團隊領導，致力於透過創新分子設計重塑癌症治療格局。
漢康生技所開發的 Fc-based designer biologics（FBDB™）平台可設計多功能生物藥，透過多元標的組合，同步激活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。透過在多功能生物藥研發領域的突破，以及具備高擴展性的 CMC（化學製造與管制）策略，漢康生技正加速推進創新藥物管線，以解決尚未被滿足的重大醫療需求。