HanchorBio Presents Early Frontline Triple-Negative Breast Cancer Data for HCB101 Combination at GBCC 2026
Oral presentation highlights early clinical activity and triplet feasibility of HCB101 in combination with anti-PD-1 and nab-paclitaxel in advanced triple-negative breast cancer
[Taipei, Shanghai, San Francisco | April 23, 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 from an ongoing study evaluating HCB101 in combination with anti-PD-1 and nab-paclitaxel in patients with advanced triple-negative breast cancer (TNBC) at the Global Breast Cancer Conference 2026 (GBCC 2026) in Seoul, Korea.
As of April 2026, HCB101 showed early clinical activity in frontline TNBC, with responses across dose levels and disease control in all 8 efficacy-evaluable patients. The combination achieved an objective response rate (ORR) of 37.5% and a disease control rate (DCR) of 100%, with no unexpected safety signals observed to date.
“These early TNBC findings strengthen our conviction that HCB101 can be developed as a differentiated innate immune backbone across combination settings,” said Scott Liu, PhD, Founder, Chairman, and Chief Executive Officer of HanchorBio. “TNBC is a difficult frontline setting where both biological relevance and combination fitness matter. We believe the macrophage- and myeloid-rich tumor microenvironment, together with the biology of the CD47–SIRPα axis, makes this an important setting in which to advance HCB101 as a combination backbone.”
Presentation Details:
Presentation ID: MO1-4
Title: Early Clinical Activity of the Novel SIRPα-IgG4 Fc Fusion Protein HCB101 in Combination with Anti-PD-1 and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer
Session Name / Location: Immunotherapy / Room 5 (Art Hall)
Date / Time: 23 April 2026 / 08:30 – 09:45 KST
Key TNBC Findings Presented at GBCC 2026
The oral presentation highlighted early signs of clinical activity and disease control for HCB101 in frontline TNBC:
- In the ongoing HCB101-201 Phase 1b/2a combination study (NCT06771622), 8 patients in the frontline TNBC cohort were evaluable for efficacy as of April 2026.
- The combination achieved an ORR of 37.5% and a DCR of 100% in this early dataset.
- Responses were observed across dose levels, including 1 confirmed PR and 2 SDs at 2.56 mg/kg, and 2 PRs and 1 SD at 8 mg/kg. Tumor shrinkage in all PR patients continued with ongoing weekly treatment, with the deepest tumor reduction reaching up to -84%.
- At 12 mg/kg, 2 additional patients had achieved SD, with follow-up evaluations still pending.
- No unexpected safety signals had emerged, supporting the early feasibility of HCB101 in a frontline triplet setting
TNBC is characterized by a highly immunosuppressive tumor microenvironment with substantial macrophage and myeloid involvement, supporting the rationale for targeting the CD47–SIRPα innate immune checkpoint. Preclinical TNBC data presented in the deck further supported combining HCB101 with PD-1 blockade, showing dose-dependent antitumor activity in a PBMC-humanized MDA-MB-453 model. Together, the preclinical and early clinical findings support the development of HCB101 as an innate-immune backbone in frontline TNBC.
“What matters in frontline TNBC is whether a new mechanism can add real biological value to an established PD-1 plus chemotherapy regimen,” said Alvin Luk, PhD, MBA, CCRA, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio. “The early signal presented at GBCC suggests HCB101 may have the potential to do that, with initial antitumor activity across dose levels and an emerging safety profile that appears compatible with triplet development. These findings support continued development of an innate plus adaptive triplet strategy in this disease.”
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.
漢康生技於GBCC 2026發表HCB101聯合療法一線三陰性乳癌早期數據
口頭報告顯示HCB101合併抗PD-1及白蛋白結合型紫杉醇於晚期三陰性乳癌具早期臨床活性，並支持三聯療法可行性
【台北、上海、舊金山｜2026年4月23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，今日宣布於韓國首爾舉行的 2026 全球乳癌大會（Global Breast Cancer Conference, GBCC）中，首次發表正在進行中的 HCB101 聯合抗 PD-1 及白蛋白結合型紫杉醇，用於治療晚期三陰性乳癌患者的臨床數據。
截至2026年4月，HCB101 於一線三陰性乳癌治療中展現初步臨床活性，各劑量組皆觀察到腫瘤緩解，8例可評估療效患者皆達疾病控制。該聯合方案客觀緩解率為37.5%，疾病控制率達100%，且迄今未觀察到預期外的安全性訊號。
「這些來自三陰性乳癌的早期研究結果，進一步增強我們將HCB101發展為差異化先天免疫骨幹療法的信心，」漢康生技創辦人、董事長兼執行長劉世高博士表示，「三陰性乳癌的一線治療具高度挑戰，不僅需具備明確的生物學機制，也需與現有療法具良好聯合潛力。我們認為，巨噬細胞與髓系細胞豐富的腫瘤微環境，加上CD47–SIRPα通路的生物學特性，使其成為推進HCB101作為聯合骨幹療法的重要適應症。」
發表資訊
• 報告編號：MO1-4
• 標題：新型SIRPα-IgG4 Fc融合蛋白HCB101聯合抗PD-1及白蛋白結合型紫杉醇治療晚期三陰性乳癌的早期臨床活性
• 場次/地點：免疫治療專場 / 5號會議室（藝術廳）
• 日期/時間：2026年4月23日 08:30–09:45（韓國時間）
GBCC 2026發表之三陰性乳癌核心數據
本次口頭報告重點呈現HCB101於一線三陰性乳癌的早期臨床活性與疾病控制訊號：
• 在進行中的HCB101-201 Ib/IIa期聯合試驗中，截至2026年4月，一線三陰性乳癌佇列共有8例患者可評估療效。
• 該聯合方案之客觀緩解率為37.5%，疾病控制率達100%。
• 各劑量組均觀察到腫瘤緩解：2.56 mg/kg劑量組出現1例確認部分緩解及2例疾病穩定；8 mg/kg劑量組出現2例部分緩解及1例疾病穩定。所有達部分緩解的患者，其腫瘤縮小幅度隨每週治療持續加深，最大縮小幅度達-84%。
• 12 mg/kg劑量組另有2例患者達疾病穩定，目前仍持續追蹤評估中。
• 未觀察到預期外安全性訊號，支持HCB101於一線三聯療法中的早期可行性。
三陰性乳癌的腫瘤微環境具有高度免疫抑制特徵，伴隨顯著的巨噬細胞與髓系細胞浸潤，為靶向CD47–SIRPα先天免疫檢查點提供了明確的科學基礎。本次報告所呈現的臨床前三陰性乳癌數據亦進一步支持HCB101與PD-1阻斷療法的聯合應用，在PBMC人源化MDA-MB-453模型中展現劑量依賴性的抗腫瘤活性。整合臨床前與早期臨床結果，支持HCB101作為一線三陰性乳癌先天免疫骨幹療法的開發潛力。
「在一線三陰性乳癌治療中，關鍵在於新機制是否能為既有PD-1合併化療方案帶來實質的生物學增益，」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。「GBCC所公布的早期訊號顯示HCB101具備此一潛力，各劑量組均觀察到初步抗腫瘤活性，且安全性表現支持三聯療法的持續開發。這些發現進一步支持在此適應症中推進先天免疫結合適應性免疫的三聯治療策略。」
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。