HanchorBio Reports Early Taiwan IIT Signal in 2L CRC With Sustained Disease Control Beyond 37 Weeks
Early investigator-initiated data support continued evaluation of HCB101-based combinations in second-line colorectal cancer
[Taipei, Shanghai, San Francisco | April 3, 2026] – HanchorBio, Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced early findings from an ongoing investigator-initiated trial (IIT) in Taiwan evaluating HCB101-based combination therapy in patients with second-line colorectal cancer (CRC).
The Taiwan IIT is an open-label Phase 1b/2a study evaluating HCB101 in combination with standard second-line treatment regimens in patients with unresectable locally advanced or metastatic colorectal cancer. The protocol includes weekly HCB101 in combination with investigator-selected bevacizumab or cetuximab together with FOLFOX or FOLFIRI, based on prior treatment history. Eligible patients are adults with histologically or cytologically confirmed advanced CRC who are RAS wild-type and BRAF wild-type and have failed prior chemotherapy for locally advanced or metastatic disease.
The first three evaluable second-line CRC subjects treated in this Taiwan IIT have been assessed to date. Among these three subjects, all achieved stable disease as the best observed response, and two remained on treatment with sustained disease control for more than 37 weeks (7.1 months). Based on treatment records, one subject received HCB101 in combination with bevacizumab and mFOLFOX6, and a second subject received HCB101 in combination with bevacizumab and FOLFIRI. Both subjects remained on therapy for approximately 10 cycles, with repeated stable disease assessments over time. A third subject initially achieved stable disease but came off study earlier. These early subject-level observations suggest potentially durable disease control in a difficult-to-treat second-line CRC setting.
“The design logic behind this CRC IIT is highly consistent with the biology of HCB101,” said Scott Liu, PhD, Founder and Chairman of HanchorBio. “HCB101 is engineered to block the CD47-SIRPα innate immune checkpoint while preserving hematologic tolerability, making it well-suited for combination development with established antibody- and chemotherapy-based regimens. In colorectal cancer, combining HCB101 with bevacizumab or cetuximab and standard chemotherapy is intended to enhance macrophage-mediated antitumor activity within a treatment regimen already familiar to physicians. These early Taiwan IIT findings are encouraging because they suggest that innate immune checkpoint modulation may help extend disease control in a setting where durable benefit remains challenging to achieve.”
Although survival data remain limited and cross-trial comparisons should be interpreted cautiously, the observed treatment durations appear promising compared to published second-line benchmark studies. In ML18147, bevacizumab combined with switched chemotherapy after initial progression was evaluated in 820 patients and showed a median overall survival (mOS) of 11.2 months; subgroup analyses also reported a median progression-free survival (mPFS) of about 6.4 months in the bevacizumab arm (Bennouna J et al., Lancet Oncology 2013). In RAISE, ramucirumab with FOLFIRI was studied in 1,072 patients and demonstrated mPFS of 5.7 months and mOS of 13.3 months (Tabernero J et al., Lancet Oncology 2015). In the extended RAS wild-type analysis of EPIC, cetuximab plus irinotecan was assessed in a 452-patient molecularly selected subgroup, with median PFS of 5.4 months and median OS of 12.3 months (Sobrero A et al., Oncologist 2021).
“Second-line metastatic colorectal cancer remains an area of high unmet medical need, even with currently available biologic and chemotherapy options,” said Alvin Luk, PhD, MBA, CCRA, President and Chief Medical Officer (Group) of HanchorBio. “In this early Taiwan IIT experience, seeing two of the first three subjects remain on treatment with sustained disease control through more than 37 weeks is clinically notable. We believe treatment duration and ongoing disease control are the most appropriate ways to describe these early findings, particularly while survival data remain immature. Although these observations are preliminary and hypothesis-generating, they support continued clinical evaluation of HCB101-based combinations in colorectal cancer.”
The Taiwan IIT is intended to explore the safety, tolerability, pharmacology, and preliminary antitumor activity of HCB101 in rational combination regimens relevant to second-line CRC practice in Taiwan. HanchorBio believes investigator-sponsored clinical experience can provide important translational insight into where innate immune checkpoint modulation may add value within established treatment paradigms.
About the Taiwan CRC IIT
The ongoing Taiwan CRC IIT is an open-label Phase 1b/2a study evaluating HCB101-based combination therapy in adults with unresectable locally advanced or metastatic colorectal cancer. Eligible patients are RAS wild-type and BRAF wild-type and must have failed prior chemotherapy for advanced disease. Under the protocol, HCB101 is administered weekly in combination with investigator-selected bevacizumab or cetuximab, with backbone selection based on prior treatment history, and administered with FOLFOX or FOLFIRI. The study is designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in a second-line treatment setting.
About HCB101
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 development across the CD47 class. HCB101 is being evaluated across multiple clinical settings as both monotherapy and combination therapy.
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’s proprietary Fc-based designer biologics (FBDB™) platform enables the design of multi-functional biologics intended to modulate innate and adaptive immune pathways with structural control over safety, exposure, and manufacturability. HanchorBio is advancing a portfolio of differentiated biologics designed to address significant unmet medical needs through innovative molecular engineering and scalable CMC strategies.
漢康生技公布台灣研究者發起的臨床研究於二線大腸直腸癌之早期訊號，疾病控制可持續超過 37 週
早期研究者發起的臨床研究數據支持持續評估 HCB101 聯合療法於二線大腸直腸癌的應用潛力
漢康生技為一家全球臨床階段生技公司，致力於推進腫瘤與自體免疫疾病的次世代免疫療法。漢康生技於台灣進行中的研究者發起的臨床研究（IIT）獲得初步數據，該研究評估 HCB101 聯合療法用於二線大腸直腸癌（CRC）患者的治療表現。
這項台灣研究者發起的臨床研究為一項開放標籤 Phase 1b/2a 試驗，評估 HCB101 與二線標準治療方案聯合使用於不可切除之局部晚期或轉移性大腸直腸癌患者的可行性。依據試驗設計，HCB101 每週給藥，並依研究者判斷，聯合使用貝伐珠單抗（bevacizumab）或西妥昔單抗（cetuximab），再搭配 FOLFOX 或 FOLFIRI，治療選擇依患者既往治療史而定。符合納入條件者須為經組織學或細胞學確認之晚期大腸直腸癌成人患者，且為 RAS 野生型、BRAF 野生型，並曾接受針對局部晚期或轉移性疾病之化學治療但治療失敗。
本次台灣研究者發起的臨床研究中，於三位受試者中，最佳觀察療效皆達疾病穩定（SD）；其中兩位受試者持續接受治療，且疾病控制維持超過 37 週（7.1 個月）。根據治療紀錄，其中一位受試者接受 HCB101 聯合貝伐珠單抗（bevacizumab）與 mFOLFOX6，另一位受試者接受 HCB101 聯合貝伐珠單抗（bevacizumab）與 FOLFIRI。兩位受試者皆持續治療約 10 個療程，且於追蹤期間多次評估均顯示疾病穩定。第三位受試者初期亦達疾病穩定，並較早退出試驗。這些早期個案層級觀察結果顯示，在治療難度較高的二線大腸直腸癌情境中，HCB101 聯合療法可能具備持久疾病控制的潛力。
漢康生技創辦人暨董事長劉世高博士表示：「這項大腸直腸癌研究者發起的臨床研究，其設計邏輯與 HCB101 的生物學機制高度一致。HCB101 經設計可阻斷 CD47-SIRPα 先天免疫檢查點，並同時避免血液學毒性，因此非常適合與既有抗體及化學治療方案進行聯合開發。在大腸直腸癌中，將 HCB101 與貝伐珠單抗（bevacizumab）或西妥昔單抗（cetuximab）及標準療法聯用，目的在於於臨床醫師熟悉的治療架構中，進一步增強巨噬細胞介導的抗腫瘤活性及持續透過抗原呈遞來激活T細胞。這些來自台灣研究者發起的臨床研究早期結果令人振奮，因其顯示，調節先天免疫檢查點可能有助於延長此類治療情境中的疾病控制時間，而這正是目前仍難以達成持久療效的領域。」
雖然目前存活數據仍有限，且跨試驗比較需審慎解讀，但目前觀察到的治療持續時間，相較已發表之二線基準研究結果，相當具有潛力。在 ML18147 試驗中，貝伐珠單抗（bevacizumab）聯合轉換後化療方案，於 820 名初次疾病惡化後患者中進行評估，中位總生存期（mOS）為 11.2 個月；次族群分析亦顯示，貝伐珠單抗組其中位無惡化存活期（mPFS）約為 6.4 個月（Bennouna J et al., Lancet Oncology 2013）。在 RAISE 試驗中，ramucirumab 聯合 FOLFIRI 於 1,072 名患者中進行研究，顯示 mPFS 為 5.7 個月，mOS 為 13.3 個月（Tabernero J et al., Lancet Oncology 2015）。在 EPIC 試驗延伸之 RAS 野生型分析中，cetuximab 聯合 irinotecan 於 452 名經分子篩選之次族群中接受評估，其中位 PFS 為 5.4 個月，中位 OS 為 12.3 個月（Sobrero A et al., Oncologist 2021）。
漢康生技總裁暨集團醫療長陸英明博士表示：「即使已有現行生物製劑與化療可供選擇，轉移性大腸直腸癌二線治療仍然存在高度未被滿足的醫療需求。在這項台灣研究者發起的臨床研究早期經驗中，首三位受試者中有兩位可持續接受治療，且疾病控制超過 37 週，在這樣相當低的初始劑量、僅有2.56mg/kg，具有臨床上的重要意義。我們認為，在存活資料仍未成熟的現階段，以治療持續時間與持續疾病控制來描述這些早期結果，是最合適的方式。雖然這些觀察結果仍屬初步、具假說生成性質，但已支持 HCB101 聯合療法於大腸直腸癌中持續進行高劑量組的臨床評估。」
這項台灣研究者發起的臨床研究，旨在探索 HCB101 於符合台灣二線大腸直腸癌臨床實務之合理聯合療法中的安全性、耐受性、藥理特性，以及初步抗腫瘤活性。漢康生技相信，由研究者主導之臨床經驗，可為先天免疫檢查點調節機制於既有治療架構中的潛在價值，提供重要的轉譯醫學洞見。
關於台灣大腸直腸癌研究者發起的臨床研究（IIT）
這項進行中的台灣大腸直腸癌研究者發起的臨床研究為一項開放標籤 Phase 1b/2a 試驗，評估 HCB101 為基礎的聯合療法，用於不可切除之局部晚期或轉移性大腸直腸癌成人患者。符合條件之患者須為 RAS 野生型及 BRAF 野生型，且曾接受晚期疾病相關化學治療但治療失敗。依據試驗設計，HCB101 每週給藥，聯合研究者選定之貝伐珠單抗（bevacizumab）或西妥昔單抗（cetuximab），並依既往治療史選擇搭配 FOLFOX 或 FOLFIRI。該試驗旨在評估二線治療情境下之安全性、耐受性、藥物動力學、藥效學，以及初步抗腫瘤活性，並以2.56 mg/kg 作為起始劑量。
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。