HanchorBio Presents Promising Phase 1 HCB101 Data at ASCO 2025 – Confirmed Partial Response Observed in Solid Tumor and Lymphoma Patients
漢康生技在 2025美國臨床腫瘤學會 ASCO 年會發表 HCB101 一期試驗佳績 —— 實體腫瘤與淋巴瘤患者皆觀察到腫瘤顯著部分縮小(緩解)
【臺北、上海與舊金山 — 2025 年 6 月 2 日】– 漢康生技是一家專注於腫瘤與自體免疫疾病創新免疫療法的全球臨床階段生技公司，今日宣布，其免疫療法候選藥物HCB101 的一期初步臨床數據已於2025 年美國臨床腫瘤學會（ASCO）年會海報發表，該會議於 5 月 31 日至 6 月 4 日在芝加哥舉行。本次展示的數據顯示，HCB101具備良好的安全性、高CD47受體佔據率（receptor occupancy），以及早期的抗腫瘤活性訊號，並在邊緣帶型淋巴瘤（Marginal Zone Lymphoma）患者及頭頸癌患者中觀察到確認的腫瘤顯著部分縮小(緩解)（Partial Response, PR）。
這項進行中的第一期劑量爬升試驗（NCT05892718）旨在評估HCB101的安全性與初步療效。HCB101為一種經改構設計（engineered）的SIRPα-Fc融合蛋白，可針對CD47-SIRPα訊號通路進行阻斷，强化巨噬細胞吞噬作用並活化先天性免疫，同時避免過往其他 CD47 抑制劑常見的血液毒性。截至 2025年4月23日，該試驗已於美國、台灣與中國大陸共納入36位受試者。
主要發現摘要如下：
o 在多個劑量等級中展現良好的安全性與耐受性
o 於外周免疫細胞中觀察到高程度的 CD47 受體佔據率
o 於頭頸癌（HNSCC）與非何杰金氏淋巴瘤患者中觀察到腫瘤顯著部分縮小(緩解)（PR）
此外，亦觀察到顯著的抗腫瘤活性：共有 六位患者於治療後呈現腫瘤受到控制(穩定疾病,Stable Disease, SD），其中一位卵巢癌患者（劑量為 1.28 mg/kg）達到超過 24 周的腫瘤受到控制。另有 兩位患者出現腫瘤顯著部分縮小(緩解)（PR）。其中一位頭頸癌患者（劑量為 5.12 mg/kg）於第 8 周時腫瘤總徑（SOD）縮小 27%，隨後於第 16 週進一步縮小至 42%，達到確認的腫瘤顯著部分縮小(緩解)（PR）。另一位邊緣帶型淋巴瘤患者（劑量為 8 mg/kg）則於第 8 週經由 PET 影像檢查觀察到確認的 腫瘤顯著部分縮小(緩解)（PR）。
「我們很榮幸能在 ASCO 2025發表 HCB101第一階段臨床試驗數據，」漢康生技創始人、董事長兼執行長劉世高博士表示。「HCB101是首個在第一階段臨床試驗中，以單藥展現良好安全性、高度受體佔有率 (receptor occupancy)，以及在實體腫瘤患者中表現出潜在療效改構的 SIRPα-Fc 融合蛋白。不同於先前的 CD47 靶向療法，HCB101 在設計上專爲克服目標相關毒性及對聯合療法依賴性的問題，並展現出較野生型SIRPα-Fc蛋白 約1000倍 的訊號阻斷能力。此次於晚期實體腫瘤與復發／難治型非何杰金氏淋巴瘤（R/R NHL）患者中觀察到的臨床反應，更進一步驗證 HCB101 作為同類最佳（best-in-class）巨噬細胞檢查點抑制劑的潛力。這項里程碑也更堅定了我們的信念： HCB101 可望成為次世代腫瘤與自體免疫疾病聯合療法的關鍵基石。」
該名非何杰金氏淋巴瘤（NHL）患者與頭頸癌（HNSCC）患者的腫瘤顯著部分縮小(緩解)（PR）為此項計畫的重要突破，顯示 HCB101 在實體瘤與血液腫瘤治療上的潛力。影像學與藥效動力學數據已於 2025 年 6 月 2 日的 ASCO 海報場次中發表。
HCB101 採用漢康生技專有的 FBDB™ 平臺開發，該平臺透過 Fc 結構優化與 SIRPα 工程設計，使藥物能有效阻斷 CD47「別吃我」訊號，促進巨噬細胞吞噬腫瘤細胞，且不誘發紅血球毒性—這是前代 CD47 抑制劑面臨的主要挑戰。重複劑量的臨床前研究也顯示無明顯血液學毒性，與目前臨床觀察到的良好安全性一致。
「我們對於觀察到的初步療效訊號深感鼓舞，特別是在邊緣帶型淋巴瘤患者及頭頸癌患者中確認的腫瘤顯著部分縮小(緩解)（PR），以及多位實體腫瘤患者中持續穩定的病情控制，」漢康生技醫學長(Chief Medical Officer) 嚴嵐博士(Lucy Yan, M.D., Ph.D.)表示。「這些結果顯示，HCB101 的作用機制有望轉化爲具臨床價值的療效，同時避免其他 CD47 抑制劑常見的血液毒性問題。」
基於這些試驗佳績，漢康生技正積極推動擴大劑量試驗、啓動聯合
療法研究，並持續展開全球策略合作討論，以加速推進HCB101及其FBDB™平臺的臨床與商業化進程。
【TAIPEI, SHANGHAI, and SAN FRANCISCO, June 02, 2025】– HanchorBio Inc., a global clinical-stage biotechnology company developing innovative immunotherapies for oncology and autoimmune diseases, today presented interim data from its lead immunotherapy product, HCB101, following its poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 31 – June 4 in Chicago, Illinois. The data, featured in a poster session, demonstrated favorable safety, high CD47 receptor occupancy, and early clinical signs of anti-tumor activity, including confirmed partial response (PR) in patients with head and neck cancer (HNSCC) and marginal zone lymphoma.
The ongoing Phase 1 dose-escalation trial (NCT05892718) is evaluating HCB101, a differentiated (engineered) SIRPα-Fc fusion protein targeting CD47-SIRPα signaling pathway, in patients with advanced solid tumors or relapsed/refractory (R/R) non-Hodgkin lymphomas (NHLs). As of April 23, 2025, the study had enrolled 36 patients from the United States, Taiwan, and mainland China.
Key findings include:
oFavorable safety and tolerability across escalating doses
oHigh-level CD47 receptor occupancy in peripheral immune cells
oPartial responses were observed in patients with head and neck cancer (HNSCC) and NHL
Importantly, early signs of anti-tumor activity were observed. Six patients reported Stable Disease (SD) as the best response, one of which with ovarian cancer (1.28 mg/kg) exceeded 24 weeks of disease control. Two patients reported Partial Response (PR), one of which with HNSCC (5.12 mg/kg) initially exhibited a 27% reduction in the sum of diameters (SOD) for target lesions at week 8, which subsequently deepened to a confirmed PR with a 42% SOD reduction at week 16. Another confirmed PR was observed via PET imaging at week 8 in a patient with marginal zone lymphoma (8 mg/kg).
“We are honored to share the HCB101 Phase 1a data following our presentation at ASCO 2025,” said Scott Liu, Ph.D., Founder, Chairman, and Chief Executive Officer of HanchorBio. “HCB101 is the first engineered SIRPα-Fc fusion protein to show favorable safety, robust receptor occupancy, and signs of anti-solid-tumor efficacy in patients with advanced cancers – all as a monotherapy in a Phase 1a clinical setting. Unlike earlier CD47-targeting agents, HCB101 was specifically designed to overcome limitations related to on-target toxicities and dependency on combination therapies while exhibiting a drastically enhanced (~1000-fold greater than wild-type SIRPα-Fc fusion proteins) ability to block the “do not eat me” signal generated by CD47. The clinical responses observed in patients with advanced solid tumors and R/R NHL further validate HCB101’s potential as a best-in-class macrophage checkpoint immunotherapy. This milestone reinforces our conviction that HCB101 can serve as a foundational asset for next-generation combinations in both oncology and autoimmune diseases.”
The confirmed partial response in the NHL patient and the HNSCC patient marks a significant milestone for the HCB101 program, highlighting its therapeutic potential in both solid tumors and hematologic malignancies. Radiographic and pharmacodynamic evidence of response was presented during the poster session at ASCO on June 2, 2025.
Developed using HanchorBio’s proprietary FBDB™ platform, HCB101 is engineered to block the SIRPα-CD47 ‘don’t-eat-me’ signal and promote macrophage-mediated tumor phagocytosis without inducing red blood cell-related toxicity—a major hurdle for previous CD47 inhibitors. Repeat-dose preclinical studies confirmed no meaningful hematologic toxicity, which is consistent with the manageable safety profile observed to date in the clinic.
“We are highly encouraged by the preliminary efficacy signals, especially the partial response in a marginal zone lymphoma patient and a HNSCC patient, and multiple long-lasting stable diseases in patients with solid tumors such as head and neck, colon, and ovarian cancer,” said Lucy Yan, M.D., Ph.D., Chief Medical Officer of HanchorBio. “These results suggest that HCB101’s mechanism of action can translate into meaningful clinical benefit while avoiding the hematologic liabilities that have hindered other CD47 agents.”
Building on these promising findings, HanchorBio is actively advancing expansion cohorts, combination strategies, and global partnership discussions to accelerate the development of HCB101 and its FBDB™ platform.