Maplirpacept

最新突破壁报展示HCB101优异的安全性、强大的受体占据率、以及在传统免疫疗法不敏感肿瘤中令人鼓舞的单药及联合疗效 2025 汉康生技 在癌症免疫治疗学会(SITC)2025年会 公布两项HCB101最新突破研究 彰显其在晚期癌症中同类最优潜力 [台北，上海，旧金山 | 2025年11月7日] – 致力于开发下一代肿瘤与自身免疫疾病免疫疗法的全球临床阶段生物技术公司汉康生技（TPEx: 7827）今日宣布，在美国马里兰州国家港湾举行的第40届癌症免疫治疗学会(SITC)年会上，公布了两项关于其核心资产HCB101的最新突破研究。两项数据集均被遴选为最新突破壁报展示，凸显了该项目在先天免疫检查点阻断领域的潜在影响力。 HCB101成CD47 领域新标杆 HCB101的进展反映了其相较于早期CD47靶向方法的独特工程化设计。第一代CD47抗体（如Magrolimab和Lemzoparlimab）虽显示出临床活性，但面临显著的安全性或疗效挑战，导致研发终止或合作中止。第二代野生型SIRPα融合蛋白（如Maplirpacept）改善了安全性，但在实体瘤中未能提供足够疗效，限制了其应用。基于IgG1的融合蛋白试图增强免疫激活，却引发了过度的Fcγ介导的毒性和较差的耐受性，使其主要限于血液恶性肿瘤。第三代采用失活IgG1 Fc的工程化SIRPα融合蛋白在联合治疗中改善了安全性，但 standalone 疗效有限。 "HCB101的单药和联合治疗数据有两项被SITC接受为最新突破研究，连同我们早前公布的靶向SIRPα/CD47、PD-1/PD-L1和TGFβ的三特异性融合蛋白HCB301的临床前研究，这共同印证了我们平台在先天与适应性免疫领域的科学广度，"汉康生技创始人、董事长兼首席执行官刘世高博士表示，"HCB101的工程化设计旨在克服第一代抗CD47抗体出现的血细胞减少问题，同时保持强效的免疫激活能力。在二线胃癌中，HCB101与标准治疗联合，在有效剂量组实现了100%的确认缓解率，远超RAINBOW临床试验中28%的ORR基准。这些结果使HCB101不仅定位为更安全的SIRPα-CD47基石疗法，更是一款具有同类最优潜力的下一代巨噬细胞检查点免疫疗法。"  最新突破研究亮点（数据截至2025年8月） 01 HCB101-101 单药治疗研究 (NCT05892718) HCB101，一款新一代Fc工程化SIRPα-CD47融合蛋白，在晚期癌症中展现出良好安全性和早期抗肿瘤活性 在正在进行的1a期剂量递增中，剂量爬坡至24 mg/kg仍未观察到剂量限制性毒性。 在剂量≥5 mg/kg时，CD47受体占据率≥99%，且药代动力学呈剂量比例关系。 在头颈鳞状细胞癌和边缘区淋巴瘤中观察到确认的部分缓解。 数名患者达到疾病稳定，无进展生存期最长可达32周。 02 HCB101-201 联合治疗研究 (NCT06771622) HCB101联合标准疗法在免疫"冷"型晚期实体瘤中的1b/2a期研究显示可控的安全性和剂量依赖性抗肿瘤活性 在二线胃癌中： · 与雷莫西尤单抗和紫杉醇联用时，在有效剂量组达到100%的确认部分缓解率。 · 肿瘤缩小高达78%，超越RAINBOW研究约26.5%的ORR基准。 在一线三阴性乳腺癌中： ·在有效剂量下观察到确认的部分缓解，肿瘤缩小73%。 安全性可控，与其"对血细胞减少影响轻微"的设计一致，仅观察到极轻微的血液学影响。 "HCB101的独特之处在于，它通过最小化红细胞结合，避免了曾困扰抗CD47抗体的血细胞减少问题，同时仍能强效结合肿瘤细胞上的CD47，"滨州医学院附属医院的研究员宁芳岭博士评论道，"在我们的胃癌队列中，有效剂量组观察到的缓解令人鼓舞，尤其是在这个历来治疗选择有限的患者群体中。这些发现验证了HCB101的独特设计，并表明其在免疫'冷'肿瘤中具有重要潜力。" 关于HCB101 HCB101是一款基于汉康生技专有FBDB™平台开发的3.5代、亲和力优化的SIRPα-Fc融合蛋白，具有完整的IgG4 Fc骨架。其设计旨在实现选择性CD47靶向，同时降低与红细胞的结合，从而避免了早期抗CD47单克隆抗体常见的贫血和血小板减少症，同时保留了强大的抗体依赖性细胞吞噬作用以及先天免疫到适应性免疫的桥接功能。 · 安全性更佳：对血细胞减少影响轻微，在剂量高达30 mg/kg时未观察到DLT，且在≥1.28 mg/kg剂量下受体占据率>90，支持其宽广的治疗窗。 · 强大的免疫激活：经工程化改造以增强ADCP并桥接先天性与适应性免疫，在单药治疗中显示出持久的免疫介导的肿瘤控制证据。 · 广泛的肿瘤适用性：在超过80个PDX和CDX临床前模型中显示出活性，并在胃癌、TNBC、头颈鳞癌、非霍奇金淋巴瘤和卵巢癌中观察到早期临床信号。 · 临床转化成果：单药治疗显示出持久的疾病控制；在与雷莫西尤单抗和紫杉醇联合用于二线胃癌治疗时，确认的客观缓解率达到100%；此外，在一线TNBC和二线头颈鳞癌中也观察到确认的缓解，疗效显著超越历史基准。 关于汉康生技： 汉康生技（HanchorBio, 股票代码：7827.TPEx）是一家全球性免疫肿瘤生物技术公司，设有台北、上海与旧金山湾区办事处。公司由一支在全球生物药研发与产业化领域拥有成功经验的资深团队领导，致力于重塑癌症治疗格局。公司自研的Fc融合蛋白设计平台FBDB™（Fc-based Designer Biologics）支持多靶点创新分子构型开发，激活先天与适应性免疫系统，突破传统PD-1/PD-L1疗法在耐药性与疗效持续性上的局限。FBDB™平台已在多个体内肿瘤模型中获得概念验证（POC）数据。汉康生技在多功能分子设计与CMC工艺优化方面不断突破，持续开发具有颠覆潜力的创新生物药，以满足尚未满足的重大临床需求。更多信息请访问官方网站：www.HanchorBio.com Late-breaking poster presentations show HCB101’s favorable safety, strong receptor occupancy, and promising monotherapy and combination activity in tumors historically unresponsive to immunotherapy 2025 HanchorBio Presents Two Late-Breaking  Abstracts at the Society for Immunotherapy  of Cancer 2025 Demonstrating Best-in-Class Potential of HCB101 in Advanced Cancers [Taipei, Shanghai, and San Francisco | November 7, 2025] –HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the presentation of two late-breaking abstracts on its lead asset, HCB101, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held November 5-9, 2025, in National Harbor, Maryland. Both datasets were accepted for late-breaking poster presentations, highlighting the program’s potential impact on innate immune checkpoint blockade. HCB101 becomes a new benchmark in the CD47 field HCB101’s progress reflects its distinct engineering compared to earlier CD47-targeting approaches. First-generation CD47 antibodies, such as magrolimab and lemzoparlimab, demonstrated clinical activity but faced significant safety or efficacy challenges, leading to discontinuations or halted collaborations. Second-generation wild-type SIRPα fusions, such as maplirpacept (TTI-622), improved safety but did not deliver sufficient efficacy in solid tumors, limiting their adoption. IgG1-based fusions attempted to boost immune activation but triggered excessive Fcγ-mediated toxicity and poor tolerability, restricting their use mainly to hematologic malignancies. Third-generation engineered SIRPα fusions with inactivated IgG1 Fc improved safety in combinations but showed limited standalone efficacy.  “The acceptance of two late-breaking abstracts at SITC for HCB101 monotherapy and combination therapy, along with our earlier preclinical abstract for HCB301, a tri-specific fusion targeting SIRPα/CD47, PD-1/PD-L1, and TGFβ, reinforces the scientific breadth of our platform across innate and adaptive immunity,” said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. “HCB101 was purposely engineered to overcome the cytopenias seen with first-generation anti-CD47 antibodies while maintaining potent immune activation. In second-line gastric cancer, the combination of HCB101 with standard-of-care therapy achieved a 100% confirmed response rate in the active-dose cohort, far exceeding the 28% ORR benchmark from the RAINBOW trial. These results position HCB101 not just as a safer SIRPα-CD47 backbone, but as a next-generation macrophage checkpoint immunotherapy with best-in-class potential.” Late-Breaking Abstract Highlights (Data as of August 2025) 01 HCB101-101 Monotherapy Study (NCT05892718) HCB101, a Next-Generation Fc-Engineered SIRPα-CD47 Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity in Advanced Cancers In the ongoing Phase 1a dose-escalation, no dose-limiting toxicities (DLTs) have been observed at doses up to 24 mg/kg. CD47 receptor occupancy ≥99% achieved at doses ≥5 mg/kg, with dose-proportional pharmacokinetics. Confirmed partial responses seen in head and neck squamous cell carcinoma (HNSCC) and marginal zone lymphoma (MZL). Several patients achieved stable disease, with progression-free survival up to 32 weeks. 02 HCB101-201 Combination Therapy Study (NCT06771622) Phase 1b/2a Study of HCB101 Combined with Standard Therapies Demonstrates Manageable Safety and Dose-Dependent Antitumor Activity in Immunologically Cold Advanced Solid Tumors In second-line gastric cancer (GC): · 100% confirmed partial response rate (6/6 evaluable patients) at active doses when combined with ramucirumab and paclitaxel. · Tumor shrinkage up to 78%, surpassing the ~26.5% ORR benchmark from RAINBOW. In first-line triple-negative breast cancer (TNBC): · Confirmed partial response with 73% tumor reduction at the effective dose. Safety was manageable and consistent with the cytopenia-sparing design, with only minimal hematologic effects observed. Dr. Fangling Ning, Investigator from the Affiliated Hospital of Binzhou Medical University, commented, “What’s unique about HCB101 is that it avoids the cytopenias that plagued anti-CD47 antibodies by minimizing red blood cell binding, while still engaging CD47 strongly on tumor cells. In our gastric cancer cohort, the responses at active doses are encouraging in a patient population that historically has had limited options. These findings validate HCB101’s unique design and suggest meaningful potential in immunologically cold tumors.” About HCB101 HCB101 is a 3.5th-generation, affinity-optimized SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio’s proprietary FBDB™ platform. It is engineered for selective CD47 targeting with low red blood cell (RBC) binding, thereby avoiding the anemia and thrombocytopenia commonly associated with earlier anti-CD47 monoclonal antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging. Key differentiators of HCB101: Enhanced safety: Cytopenia-sparing profile, with no DLTs observed up to 30 mg/kg and receptor occupancy >90% at ≥1.28 mg/kg, supporting a broad therapeutic window. Robust immune activation: Engineered to enhance ADCP and bridge innate-to-adaptive immunity, with evidence of durable immune-mediated tumor control in monotherapy. Broad tumor applicability: Demonstrated activity across >80 PDX and CDX preclinical models, with early clinical signals in gastric cancer, TNBC, HNSCC, non-Hodgkin lymphoma, and ovarian cancer. Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in 2L gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in 1L TNBC and 2L HNSCC, substantially exceeding historical benchmarks. About HanchorBio： Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TPEx: 7827) is a global biotechnology company specializing in immuno-oncology. It is led by an experienced team of pharmaceutical industry veterans with a proven track record in biologics discovery and international development, aiming to rewrite the landscape of cancer therapies. Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By advancing breakthroughs in multi-functional, innovative molecular configurations in R&D and improving CMC manufacturing processes, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: www.HanchorBio.com ▼

Late-breaking poster presentations show HCB101's favorable safety, strong receptor occupancy, and promising monotherapy and combination activity in tumors historically unresponsive to immunotherapy TAIPEI, SHANGHAI, and SAN FRANCISCO, Nov. 7, 2025 /PRNewswire/ -- HanchorBio Inc. (TPEx: 7827), a global clinical-stage biotechnology company advancing next-generation immunotherapies for oncology and autoimmune diseases, today announced the presentation of two late-breaking abstracts on its lead asset, HCB101, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held November 5-9, 2025, in National Harbor, Maryland. Both datasets were accepted for late-breaking poster presentations, highlighting the program's potential impact on innate immune checkpoint blockade. Continue Reading HCB101, a Next-Generation Fc-Engineered SIRPα-CD47 Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity in Advanced Cancers HCB101's progress reflects its distinct engineering compared to earlier CD47-targeting approaches. First-generation CD47 antibodies, such as magrolimab and lemzoparlimab, demonstrated clinical activity but faced significant safety or efficacy challenges, leading to discontinuations or halted collaborations. Second-generation wild-type SIRPα fusions, such as maplirpacept (TTI-622), improved safety but did not deliver sufficient efficacy in solid tumors, limiting their adoption. IgG1-based fusions attempted to boost immune activation but triggered excessive Fcγ-mediated toxicity and poor tolerability, restricting their use mainly to hematologic malignancies. Third-generation engineered SIRPα fusions with inactivated IgG1 Fc improved safety in combinations but showed limited standalone efficacy. "The acceptance of two late-breaking abstracts at SITC for HCB101 monotherapy and combination therapy, along with our earlier preclinical abstract for HCB301, a tri-specific fusion targeting SIRPα/CD47, PD-1/PD-L1, and TGFβ, reinforces the scientific breadth of our platform across innate and adaptive immunity," said Scott Liu, Ph.D., Founder, Chairman, and CEO of HanchorBio. "HCB101 was purposely engineered to overcome the cytopenias seen with first-generation anti-CD47 antibodies while maintaining potent immune activation. In second-line gastric cancer, the combination of HCB101 with standard-of-care therapy achieved a 100% confirmed response rate in the active-dose cohort, far exceeding the 28% ORR benchmark from the RAINBOW trial. These results position HCB101 not just as a safer SIRPα-CD47 backbone, but as a next-generation macrophage checkpoint immunotherapy with best-in-class potential." Late-Breaking Abstract Highlights (Data as of August 2025) 1. HCB101-101 Monotherapy Study (NCT05892718) Title: HCB101, a Next-Generation Fc-Engineered SIRPα-CD47 Fusion Protein, Demonstrates Favorable Safety and Early Antitumor Activity in Advanced Cancers In the ongoing Phase 1a dose-escalation, no dose-limiting toxicities (DLTs) have been observed at doses up to 24 mg/kg. CD47 receptor occupancy ≥99% achieved at doses ≥5 mg/kg, with dose-proportional pharmacokinetics. Confirmed partial responses seen in head and neck squamous cell carcinoma (HNSCC) and marginal zone lymphoma (MZL). Several patients achieved stable disease, with progression-free survival up to 32 weeks. 2. HCB101-201 Combination Therapy Study (NCT06771622) Title: Phase 1b/2a Study of HCB101 Combined with Standard Therapies Demonstrates Manageable Safety and Dose-Dependent Antitumor Activity in Immunologically Cold Advanced Solid Tumors In second-line gastric cancer (GC): 100% confirmed partial response rate (6/6 evaluable patients) at active doses when combined with ramucirumab and paclitaxel. Tumor shrinkage up to 78%, surpassing the ~26.5% ORR benchmark from RAINBOW. In first-line triple-negative breast cancer (TNBC): Confirmed partial response with 73% tumor reduction at the effective dose. Safety was manageable and consistent with the cytopenia-sparing design, with only minimal hematologic effects observed. Dr. Fangling Ning, Investigator from the Affiliated Hospital of Binzhou Medical University, commented, "What's unique about HCB101 is that it avoids the cytopenias that plagued anti-CD47 antibodies by minimizing red blood cell binding, while still engaging CD47 strongly on tumor cells. In our gastric cancer cohort, the responses at active doses are encouraging in a patient population that historically has had limited options. These findings validate HCB101's unique design and suggest meaningful potential in immunologically cold tumors." About HCB101: A Differentiated CD47-SIRPα Blockade HCB101 is a 3.5th-generation, affinity-optimized SIRPα-Fc fusion protein with an intact IgG4 Fc backbone, developed using HanchorBio's proprietary FBDB™ platform. It is engineered for selective CD47 targeting with low red blood cell (RBC) binding, thereby avoiding the anemia and thrombocytopenia commonly associated with earlier anti-CD47 monoclonal antibodies, while preserving strong antibody-dependent cellular phagocytosis (ADCP) and innate-to-adaptive immune bridging. Key differentiators of HCB101: Enhanced safety: Cytopenia-sparing profile, with no DLTs observed up to 30 mg/kg and receptor occupancy >90% at ≥1.28 mg/kg, supporting a broad therapeutic window. Robust immune activation: Engineered to enhance ADCP and bridge innate-to-adaptive immunity, with evidence of durable immune-mediated tumor control in monotherapy. Broad tumor applicability: Demonstrated activity across >80 PDX and CDX preclinical models, with early clinical signals in gastric cancer, TNBC, HNSCC, non-Hodgkin lymphoma, and ovarian cancer. Clinical translation: Shows durable disease control as monotherapy and a 100% confirmed partial response rate (6/6) in 2L gastric cancer when combined with ramucirumab and paclitaxel, with additional confirmed responses in 1L TNBC and 2L HNSCC, substantially exceeding historical benchmarks. About HanchorBio Based in Taipei, Shanghai, and the San Francisco Bay Area, HanchorBio (TPEx: 7827) is a global biotechnology company specializing in immuno-oncology. It is led by an experienced team of pharmaceutical industry veterans with a proven track record in biologics discovery and international development, aiming to rewrite the landscape of cancer therapies. Committed to reactivating the immune system to fight diseases, the proprietary Fc-based designer biologics (FBDB™) platform enables the development of unique biologics with diverse multi-targeting modalities, unleashing both innate and adaptive immunity to overcome the current challenges of anti-PD1/L1 therapies. The FBDB™ platform has successfully delivered proof-of-concept data in several in vivo tumor animal models. By advancing breakthroughs in multi-functional, innovative molecular configurations in R&D and improving CMC manufacturing processes, HanchorBio develops transformative medicines to address unmet medical needs. For more information, please visit: SOURCE HanchorBio Inc. 21% more press release views with Request a Demo