The goal of this clinical trial is to etablish whether adding Mitazalimab to standard chemotherapy is more effective than standard chemotherapy alone in people with advanced bile duct cancer. It will also learn about the safety of Mitazalimab.
The main questions it aims to answer are:
* Does the addition of Mitazalimab enhance efficacy?
* What medical problems do participants have when taking Mitazalimab + mFOLFOX?
Participants will:
* Take drug mFOLFOX every two weeks until disease progression or mFOLFOX every two weeks plus mitazalimab in addition to mFOLFOX, with a first injection 7 days before the first mFOLFOX chemotherapy and then 3 days after the start of each mFOLFOX cycle.
* Visit the clinic once every 2 weeks for checkups and tests
* Have a radiological assessment every 8 weeks during treatment. After stopping treatment, participants will be monitored at the hospital every 8 weeks if no progression is observed, or every 12 weeks after disease progression.

开始日期2026-07-01

申办/合作机构

UNICANCER

[+1]

NCT07319195

/ Recruiting早期临床1期IIT

Window of Opportunity Study of Intratumoral CD40 Agonist (Mitazalimab) With or Without PD-1 Inhibitor (Nivolumab) in Patients With Resectable Breast Cancer (WINIT-BC)

The goal of this clinical trial is to study the safety, feasibility, histologic and immunological effects of Mitazalimab, a CD40 agonistic antibody, when administered either alone or in combination with PD-1 inhibition prior to surgical resection.
The investigator hypothesizes that preoperative administration of CD40 agonist with or without PD-1 inhibitor intratumorally will demonstrate an acceptable safety profile, will not result in an unplanned delay in surgery, and will lead to increased immune activation.
Subjects will receive a single intratumoral dose of CD40 agonist with or without PD-1 inhibitor 7 or more days prior to surgery and will be followed for safety, feasibility, immune, and pathologic responses.

开始日期2026-04-27

申办/合作机构

University of Pennsylvania

[+1]

NCT07199764

/ Recruiting临床2期IIT

IGNITE: A Phase 2 Study of Maintenance Combinatorial Myeloid Immunotherapy in Patients With Unresectable Pancreatic Ductal Adenocarcinoma

Phase II, open-label, single-arm study of CD40/Dectin-1 immunotherapy as maintenance treatment in patients with unresectable pancreatic ductal adenocarcinoma (PDA) who have not progressed following 4-8 months of first line (1L) chemotherapy.

开始日期2025-11-25

申办/合作机构

University of Pennsylvania

[+1]

100 项与米佐利单抗相关的临床结果

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100 项与米佐利单抗相关的转化医学

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100 项与米佐利单抗相关的专利（医药）

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项与米佐利单抗相关的文献（医药）

2025-10-01·Cell Reports Medicine

CD40 agonist mitazalimab with mFOLFIRINOX in untreated metastatic pancreatic cancer: Biomarkers associated with outcomes from OPTIMIZE-1

Article

作者: Feliu, Jaime ; Pilla, Lorenzo ; Geboes, Karen ; Cassier, Philippe ; Gallego, Inmaculada ; Nordbladh, Karin ; Van Laethem, Jean-Luc ; Blanc, Jean-Frédéric ; Ambarkhane, Sumeet Vijay ; Ellmark, Peter ; Borbath, Ivan ; Pico de Coaña, Yago ; O'Reilly, Eileen M ; Pazo-Cid, Roberto Antonio ; Mitry, Emmanuel ; Smith, Karin Enell ; Prenen, Hans ; Macarulla Mercade, Teresa ; Lambert, Aurélien ; Jimenez, David Gomez ; Rodriguez Garrote, Mercedes ; Beatty, Gregory L

Response determinants to immunotherapy in metastatic pancreatic ductal adenocarcinoma (mPDAC) remain unclear, limiting treatment advancements. We report a single-arm phase 1b/2 study (OPTIMIZE-1) evaluating the safety and efficacy of the cluster of differentiation 40 (CD40) agonist mitazalimab combined with modified FOLFIRINOX (mFOLFIRINOX), in chemotherapy-naive patients with mPDAC. Patients receive an initial dose of mitazalimab one week before starting biweekly cycles of mFOLFIRINOX plus mitazalimab. The study meets its pre-specified primary endpoint, achieving a confirmed objective response rate (ORR) of 42.1%. Median duration of response, progression-free survival, and overall survival was 12.6 months, 7.7 months, and 14.9 months, respectively. Multi-omic analyses of tumor and blood specimens identify a baseline tumor-intrinsic gene signature related to fibrosis associated with improved survival. Additionally, mitazalimab-induced increases in activated circulating myeloid, B cell, and T cell frequencies correlate with better outcomes. These results may inform future patient stratification strategies supporting a planned randomized confirmatory trial of mitazalimab with mFOLFIRINOX in mPDAC. This study was registered at ClinicalTrials.gov (NCT04888312).

2024-07-01·LANCET ONCOLOGY

Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study

Article

作者: Inmaculada Gallego ; Jaime Feliu Batlle ; Jean-Frédéric Blanc ; Aurélien Lambert ; Emmanuel Mitry ; Yago Pico de Coaña ; Peter Ellmark ; Karin Enell Smith ; Mercedes Rodriguez Garrote ; Sumeet Vijay Ambarkhane ; Hans Prenen ; Lorenzo Pilla ; Jean-Luc Van Laethem ; Roberto Antonio Pazo-Cid ; Philippe Alexandre Cassier ; Teresa Macarulla ; Karen Paula Geboes ; Ivan Borbath

BACKGROUND:

Current systemic therapies for metastatic pancreatic ductal adenocarcinoma are associated with poor outcomes with a 5-year overall survival rate under 5%. We aimed to assess the safety and antitumour activity of mitazalimab, a human CD40 agonistic IgG1 antibody, with modified FOLFIRINOX (mFOLFIRINOX; fluorouracil, leucovorin, oxaliplatin, and irinotecan), in chemotherapy-naive patients with metastatic pancreatic ductal adenocarcinoma.

METHODS:

OPTIMIZE-1 was a single-arm, multicentre, phase 1b/2 study which enrolled adults with histologically-confirmed metastatic pancreatic ductal adenocarcinoma and European Cooperative Oncology Group performance status 0 or 1 in 14 university hospitals in Belgium, France, and Spain. The primary endpoint of phase 1b was to determine the recommended phase 2 dose of intravenous mitazalimab (450 μg/kg or 900 μg/kg) when combined with intravenous mFOLFIRINOX (oxaliplatin 85 mg/m², leucovorin 400 mg/m², irinotecan 150 mg/m², fluorouracil 2400 mg/m²). In the first 21-day treatment cycle, mitazalimab was administered on days 1 and 10, and mFOLFIRINOX on day 8. In subsequent 14-day cycles mitazalimab was administered 2 days after mFOLFIRINOX. The phase 2 primary endpoint was objective response rate. Activity and safety analyses were conducted on the full analysis set (all patients who received the combination of mitazalimab at the recommended phase 2 dose and mFOLFIRINOX for at least two treatment cycles) and safety set (all patients who received any study treatment), respectively. Enrolment is complete, and data represents a primary analysis of the ongoing trial. The trial is registered at Clinicaltrials.gov (NCT04888312).

FINDINGS:

Between Sept 29, 2021, and March 28, 2023, 88 patients were screened and 70 patients were enrolled (40 [57%] were female and 30 [43%] were male). In phase 1b, 900 μg/kg mitazalimab was determined as the recommended phase 2 dose. Overall, five patients received 450 μg/kg mitazalimab; 65 received 900 μg/kg mitazalimab. No dose-limiting toxicities were observed at 450 μg/kg, and one dose-limiting toxicity was observed at 900 μg/kg. 57 patients were evaluated for activity, and all 70 patients were included in the safety set. At data cutoff on Nov 14, 2023, median follow-up was 12·7 months (95% CI 11·1-15·7). Of the 57 patients, 29 (51%) remained on study and 18 (32%) remained on treatment. The primary endpoint (objective response rate >30%) was met (objective response rates in 23 [40%]; one-sided 90% CI ≥32 of 57 patients). The most common grade 3 or worse adverse events were neutropenia (18 [26%] of 70 patients), hypokalaemia (11 patients [16%]), and anaemia and thrombocytopenia (eight patients [11%]). Serious adverse events were reported in 29 (41%) of 70 patients, the most common being vomiting (five [7%] of 70 patients), decreased appetite (four [6%]), and diarrhoea and cholangitis (three [4%] of 70 patients for each), none considered related to mitazalimab. No treatment-related deaths were reported.

INTERPRETATION:

Mitazalimab with mFOLFIRINOX demonstrated manageable safety and encouraging activity, warranting continued development in a phase 3, randomised, controlled trial. The results from OPTIMIZE-1 pave the way for further exploration and confirmation of a novel immunotherapy treatment regimen for metastatic pancreatic ductal adenocarcinoma, which is a complex and aggressive cancer with very low survival rates and restricted treatment options.

FUNDING:

Alligator Bioscience.

2024-02-01·Cytokine & growth factor reviews

Harnessing the potential of CD40 agonism in cancer therapy

Review

作者: Yang Zhou ; Ann Richmond ; Chi Yan

CD40 is a member of the tumor necrosis factor (TNF) receptor superfamily of receptors expressed on a variety of cell types. The CD40-CD40L interaction gives rise to many immune events, including the licensing of dendritic cells to activate CD8⁺ effector T cells, as well as the facilitation of B cell activation, proliferation, and differentiation. In malignant cells, the expression of CD40 varies among cancer types, mediating cellular proliferation, apoptosis, survival and the secretion of cytokines and chemokines. Agonistic human anti-CD40 antibodies are emerging as an option for cancer treatment, and early-phase clinical trials explored its monotherapy or combination with radiotherapy, chemotherapy, immune checkpoint blockade, and other immunomodulatory approaches. In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them.

项与米佐利单抗相关的新闻（医药）

2026-11-01

·ylxu

医药前沿日报-产业篇

医药前沿日报第 306 期｜产业篇｜ 2026年11月2日AI订单暴涨30倍，CXO景气度分化订单、融资与 AI 制药三条线同时回温，客户的钱包与管线预算开始一起动。 CXO 与客户订单・投融资与资本市场・并购与合作（BD）・AI 制药　｜　编辑：予白 📌 核心速览 (Executive Summary) CXO 景气分化：药明康德在手订单达 767.4 亿元；《生物安全法案》首批限制名单将于 12 月 18 日前落地。资本市场回暖：美股前三季度 Biotech IPO 募资约 69 亿美元（达去年全年近 5 倍）；催化型降解剂平台 Lycia 首日大涨 67%。中国创新药出海：上半年 105 起对外授权交易，首付款合计约 50 亿美元，潜在总额逼近千亿美元。AI 制药送出大单：TechBio 客户湿实验订单暴涨 30 倍，每轮验证分子规模从数百跃升至 5,000 个。 05CXO与客户侧：三个核心数据与一个关键日期 ▍药明康德 Q1–Q3 2026 核心业绩指标　｜　数据　｜　同比营业总收入455.4 亿元38.6% 持续经营在手订单 (Backlog)767.4 亿元36.4% CDMO 服务收入393.6 亿元51.5% 调整后 non-IFRS 净利183.8 亿元74.4% ▍12月18日：Biosecure Act 的名单审定节点美国《Biosecure Act》已于 2025 年底成法，法案将依据五角大楼认定发布首批“受关注生物技术公司”完整名单，截止时间为 2026年12月18日前。一旦列入，联邦机构采购、合作及拨款补贴将全面受限。此外，10月22日新提案 H.R. 10859（Biotech Defense Act）正进一步强化对外部生物技术能力的审查。 ▍同行分化与传导规律：订单流向轻资产、重外包 Biotech 三季报显示 CXO 板块呈结构性分化：药明康德、昭衍新药、美迪西率先扭亏或高增，凯莱英持平，九洲药业双降。欧美融资回暖后，资金优先激活早期药物发现与临床前安全性评价，预计在随后 6 至 18 个月逐步传导至临床与商业化 CDMO 环节。纵向整合动向：10月30日，益诺思公告以 5,436 万元自有资金收购上海益临思 79.9% 股权，标志着国内临床 CRO 从“横向拼规模”走向“纵向补能力”，通过补齐 DMPK、BE 及全链条临床运营强化一体化交付。 💡 订单传导逻辑订单并非平均回流，而是向“刚完成融资的欧美 Biotech”与“具备 BD 出海能力的本土药企”集中。深度绑定国内未上市初创企业的服务商修复仍显平缓。 06投融资与资本市场：IPO 窗口重启，客户钱包回血普华永道数据显示，截至 2026 年第三季度，已有 22 家 Biotech 完成美股 IPO，累计募资约 69 亿美元（去年全年仅 7 家、募资 14 亿美元），数量达 3 倍，募资额接近 5 倍。▍近期代表性上市/融资案例 Lycia Therapeutics (LYCA)首日大涨 +67%募资约 3.18 亿美元｜定价 18 美元/股（10月23日上市）核心亮点：LYTAC 溶酶体靶向嵌合体平台，口服小分子 IgE 降解剂进入 1 期。 Iambic Therapeutics (IAM)募资 1.5 亿美元市值约 8.09 亿美元｜定价 16 美元/股（10月15日上市）核心亮点：英伟达参投 AI-native 制药，搭建“AI闭环 + 机器人高通量湿实验”体系。 Aspen Neuroscience (ASPE)募资 1.41 亿美元定价 15 美元/股（10月30日上市）核心亮点：帕金森自体 iPSC 细胞疗法 sasineprocel。 ▍中国创新药 License-out：上半年揽获 50 亿美元首付医药魔方统计，2026 上半年国内新药达成 105 起出海授权，首付款合计 50 亿美元，潜在总交易额逼近千亿美元。首付款直接支撑本土企业管线续航，而 MNC 接手后由头部 CDMO 承接高质量外包生产，形成资金与订单的双向循环。 07并购与合作：重磅交易结构与管线拆解 BMS ← BioNTech总额 111 亿美元标的：BNT327（下一代免疫肿瘤管线），首付 15 亿美元 + 联合共担成本分成辉瑞 ← 三生制药首付 14 亿美元标的：SSGJ-707 (PD-1/VEGF 双抗)，刷新出海单笔首付纪录，总额超 60 亿美元默沙东 ← SciBrunch最高 21.3 亿美元标的：SPR2015（口服 KRAS G12D (ON) 抑制剂，临床前），首付 4 亿美元 BioMarin ← GC Biopharma / 韩美最高 4.75 亿美元标的：HM15421/GC1134A（长效皮下注射 Fabry ERT），首付 7,000 万美元 💡 早期发现端信号大额首付款正进一步向具备确证临床数据的后期资产集中；早期资产更倚重里程碑与期权对赌分摊风险。CRO 需进一步强化靶点立项评估与里程碑方案设计能力。 08AI制药：从工具走向买方，湿实验订单暴增国海证券测算，2020-2025 全球 AI 制药技术交易复合增速达 30.7%。截至 2026 年 7 月，全球已达成 173 起 AI 交易，按披露口径中国贡献了约 63% 交易额与 79% 首付款。 • 英矽智能 ⇋ 施维雅：达成首个早期药物发现里程碑，英矽智能上半年总收入 1.06 亿美元 (+287%) 并实现半年度盈利。 • 剂泰科技 ⇋ 礼来：逾千万美元首付、里程碑最高 11 亿美元，围绕 NanoForge／AiLNP 平台做组织特异性 LNP 递送。 • 阿斯利康 ⇋ insitro：首付 4000 万美元、里程碑最高约 14.6 亿美元（总额约 15 亿美元），针对 MASH 与心肌病的新靶点发现。 🔥 核心动向：AI 正在给 CXO 送来成倍的湿实验订单金斯瑞 2026 投资者日披露：某全球前 20 药企单一研发基地 2026 上半年服务收入扩大至 5 倍，AIDD 从序列到数据 (S2D) 收入占比升至 64%；单轮需验证候选分子从数百个激增至 1,000–5,000 个，检测深度提升 5 倍。另一家 TechBio 客户服务收入同比暴增超 30 倍，单季度下单频次及平均批次分别提升 5 倍与 3 倍。 ▍AI-native 进阶：亲自下场做资产买方 Formation Bio 设立 6 亿美元加速基金：直接收购 10–15 个进入 1/2 期临床的项目，目标在 2–4 年内推至关键临床里程碑再转授权大药企；Biossil 收购 Alligator CD40 抗体：AI-native 公司正由单纯的算法输出方演变为持有实质性管线与资本的临床资产买方。 ★行业趋势速览 01. 资金回流传导链早期发现与临床前评价最先复苏，6 至 18 个月后向临床及生产 CDMO 传导。 02. AI 公司的双重属性AI 工具用于内部降本，而 AI-native 制药企业正在成为带来巨量验证订单的新客户群。 03. 明确政策风险时点在手订单增长的同时，12月18日公布的《Biosecure Act》关注清单将决定下一阶段地缘业务边界。参考链接｜原文溯源 1. Fierce Pharma：药明康德 Q3 表现与全年指引上调https://www.fiercepharma.com/manufacturing/wuxi-apptec-bucks-dod-uncertainty-through-q3-lifting-forecast-2026 2. 药明康德公告：2026 年前三季度业绩https://www.wuxiapptec.com/news/wuxi-news/wuxi-apptec-delivers-strong-q1-q3-2026-results-and-further-raises-full-year-guidance-driven-by-greater-success-of-multiple-customers-products-and-crdmo-model 3. 上海证券报：益诺思收购案http://paper.cnstock.com/html/2026-10/30/content_2284488.htm 4. 国泰海通核查意见摘要：CXO 板块https://stock.stockstar.com/AN2026103000024573.shtml 5. 财联社：CXO 分化与复苏调查http://m.163.com/dy/article/LAMH2IJ805567I2C.html 6. 南方+：2026 中国医药创新指数https://www.nfnews.com/content/ryepgJ59og.html 7. 横琴合作区：CHIPS 2026 官方信息https://www.hengqin.gov.cn/macao_zh_hans/hzqgl/dtyw/dtxx/content/post_3945769.html 8. H.R.10859 法案原文（Biosecure Act）https://www.govinfo.gov/bulkdata/BILLS/119/2/hr/BILLS-119hr10859ih.xml 9. BioPharm Wire：Alligator 出售 mitazalimab 给 Biossilhttps://biopharmawire.com/2026/10/31/alligator-sells-mitazalimab-to-biossil-in-upfront-and-contingent-deal/ 10. BMS 与 BioNTech 的 111 亿美元授权交易https://www.akm.ru/eng/news/american-bristol-myers-acquires-license-for-innovative-drug-from-german-biontech-for-11-1-billion/ 11. 三生国健公告：辉瑞 SSGJ-707 合作与全球执行进展https://www.3sbio.com/en/news/details.aspx?id=348 12. 辉瑞公告：完成与三生国健的 SSGJ-707 授权协议https://investors.pfizer.com/Investors/News/news-details/2025/Pfizer-Completes-Licensing-Agreement-with-3SBio/default.aspx 13. 默沙东公告：思璞锐 SPR2015 全球授权（首付 4 亿美元）https://www.merck.com/news/merck-enters-into-exclusive-global-license-agreement-with-scibrunch-therapeutics-for-spr2015-an-investigational-oral-kras-g12d-on-inhibitor/ 14. BioMarin 公告：与 GC Biopharma／韩美授权下一代酶替代疗法https://www.prnewswire.com/news-releases/biomarin-enters-into-exclusive-worldwide-license-agreement-with-gc-biopharma-and-hanmi-pharm-for-investigational-next-generation-enzyme-replacement-therapy-adding-a-second-potential-treatment-for-fabry-disease-302923678.html 15. Formation Bio 公告：6 亿美元药物开发加速基金https://www.prnewswire.com/news-releases/formation-bio-announces-600-million-debut-fund-to-expand-drug-development-capacity-302921852.html 16. 中证网：英矽智能上市后首份半年报https://www.cs.com.cn/ssgs/01/2026/08/29/detail_2026082910035587.html 17. 英矽智能公告：与施维雅的 AI 药物发现合作达成首个里程碑https://www.prnewswire.com/news-releases/insilico-medicine-and-servier-achieve-first-milestone-in-ai-driven-rd-collaboration-triggering-an-undisclosed-milestone-payment-302913644.html 18. 金斯瑞 2026 投资者开放日：AIDD 订单与序列到数据https://www.genscript.com.cn/genscript-biotech-corporation-2026-investor-day.html 19. 经济参考报：AI 制药交易提速http://www.ce.cn/cysc/newmain/yc/jsxw/202610/t20261027_3272396.shtml 20. 智通财经：中国创新药 BD 数据http://sc.stock.cnfol.com/gushizhibo/20261030/32411583.shtml 21. 新浪财经：Lycia 上市首日表现https://finance.sina.com.cn/stock/hkstock/ggscyd/2026-10-24/doc-iniwfwah1803653.shtml 22. Iambic 公告：IPO 定价https://www.iambic.ai/post/iambic-announces-pricing-of-initial-public-offering 23. 剂泰科技港交所公告：与礼来合作推进组织特异性 LNP 递送https://www1.hkexnews.hk/listedco/listconews/sehk/2026/1019/2026101900041.pdf 24. 阿斯利康公告：与 insitro 的 AI 靶点发现合作https://www.astrazeneca.com/media-centre/press-releases/2026/astrazeneca-announces-new-strategic-collaboration-with-insitro-to-use-advanced-ai-systems-to-develop-transformative-therapeutics.html 本文汇总自监管机构公开披露、企业财报与行业公告。内容仅供医药研发专业交流与参考，不构成任何投资或医疗建议。

2026-11-01

·肽集圈

Alligator Bioscience 将 CD40 激动抗体 mitazalimab 全部资产出售给 Biossil，交易首付款 75 万美元，总潜在最高 1.08 亿美元

📌 核心要点速览 ✅ 瑞典 Biotech Alligator Bioscience（斯德哥尔摩：ATORX）与 Biossil Inc 达成协议，出售 CD40 激动抗体 mitazalimab 全部全球权益与资产，包含专利、临床 / 申报数据、技术诀窍、生产物料与药物库存Alligator ...。 ✅ 交易对价：首付款 75 万美元；最高 1.08 亿美元里程碑（欧美首次获批最高 300 万美元；销售相关里程碑最高 1.05 亿美元）；外加中等个位数比例的全球净销售额特许权使用费，特许权使用费合计上限 2.5 亿美元Alligator ...。 ✅ 签约后两年内，若 Biossil 将该资产再对外转让 / 授权，Alligator 可获得该笔交易的部分收益。交割完成后，Biossil 承担全部后续开发、生产、专利相关费用，并承诺推进 mitazalimab 临床开发；交易预计签约后 30 日内完成交割。 ✅ mitazalimab 在胰腺癌临床研究中展现积极数据；Alligator 战略重心转向 HLX22（HER2 抗体）的收益权益，本次交易延长公司现金跑道，终止 mitazalimab 项目后续成本投入Alligator ...。正文瑞典隆德，2026‑10‑31（Accesswire）瑞典生物药企 Alligator Bioscience（斯德哥尔摩纳斯达克：ATORX）今日公告，已签署协议，将 CD40 激动性抗体 mitazalimab 的全部相关权利与资产出售给 Biossil Inc。Alligator 当前核心资产为 HER2 抗体项目 HLX22 的收益权益Alligator ...。根据协议约定，Biossil 获得 mitazalimab 及其衍生物全部全球权益，覆盖所有适应症与用途，受让范围包含专利、临床与申报资料、技术诀窍、生产物料以及药物库存。交割完成起，Biossil 将承担该项目后续全部开发、生产、专利维护成本，并承诺持续推进 mitazalimab 开发工作Alligator ...。交易财务条款首付款：75 万美元；注册里程碑：美国、欧盟首次获批合计最高 300 万美元；销售里程碑：与全球净销售额挂钩，最高可达 1.05 亿美元；特许权使用费：全球净销售额中等个位数比例，使用费总上限 2.5 亿美元；除首付款外，其余全部款项均取决于未来事件，不保证一定能够实现Alligator ...。额外条款：协议签署两年内，如果 Biossil 将 mitazalimab 出售或授权给第三方，Alligator 有权分得该笔交易的部分收益。本次交易尚需完成资产移交、文件交割以及第三方必要许可等常规交割条件，预计签约后 30 天内完成交割。交易所得将延长 Alligator 的现金跑道，支撑公司战略目标落地；交割后 Alligator 不再承担 mitazalimab 项目及其知识产权组合的维护成本，契合公司此前公布的战略调整方向，将资源聚焦 HLX22 的权益收益。高管表态 Alligator Bioscience 首席执行官 Søren Bregenholt： “mitazalimab 在胰腺癌研究中已经展现出令人鼓舞的数据。本次交易让该资产交到有能力推进注册性临床试验的合作方手中。重要的是，Alligator 及其股东依旧可以分享这个项目未来的价值成长。” Biossil 首席科学官兼董事长 Alexander Mosa： “感谢 Alligator 信任，将 mitazalimab 交由我们继续开发。患者与研究者为这款疗法投入了时间与期待，我们将以严谨专注的姿态推进项目，不负这份期待。”关于 Mitazalimab mitazalimab 是一款CD40 激动型抗体，属于肿瘤免疫靶点，既往在胰腺癌 II 期临床中观察到积极抗肿瘤信号，可激活树突状细胞、重启肿瘤特异性 T 细胞免疫应答。

引进/卖出

2026-11-01

·BioSpace

Alligator Bioscience Signs Agreement To Sell Mitazalimab to Biossil

LUND, SE / ACCESS Newswire / October 31, 2026 / Alligator Bioscience (STO:ATORX)(Nasdaq Stockholm:ATORX), a biotechnology company whose principal asset is a financial interest in the HER2-targeting antibody program HLX22, today announced that it has signed an agreement to sell all rights and assets related to the CD40 agonist antibody mitazalimab to Biossil Inc. ("Biossil"). Alligator will receive USD 0.75 million upfront and is eligible for up to USD 108 million in milestone payments, as well as royalties on future sales. Under the agreement, Biossil acquires worldwide rights to mitazalimab, including its derivatives, for all indications and uses, including patents, clinical and regulatory data, know-how, manufacturing materials and drug inventory. From closing, Biossil will be responsible for all further development, manufacturing and patent costs, and has committed to develop mitazalimab. As consideration, Alligator will be paid USD 0.75 million as an upfront payment. The milestone payments consist of up to USD 3 million in total upon first regulatory approval in the US and EU. In addition, Alligator is eligible for up to USD 105 million linked to worldwide net sales, and mid-single-digit royalty on worldwide net sales, capped at USD 250 million in total. All payments other than the upfront payment are contingent on future events and there can be no assurance that they will be received. If Biossil sells or licenses mitazalimab to a third party within two years of the signing of the agreement, Alligator will receive a share of the proceeds from such transaction. Alligator believes the transaction provides an attractive balance between near-term value realization and potential future upside through milestone and/or royalty-based consideration. Completion of the transaction is subject to customary closing conditions, including the transfer of assets and documentation and receipt of required third-party consents. Closing is expected within 30 days of signing. The proceeds are expected to extend Alligator's financial runway and support the execution of its strategic objectives. The sale of mitazalimab is in line with Alligator's previously communicated strategy to focus on its economic interest in HLX22 , and ends Alligator's costs for maintaining the mitazalimab program and related IP portfolio from closing. "Mitazalimab has shown promising data in pancreatic cancer, and with this agreement it gets an owner that can take mitazalimab forward towards registrational trials. Importantly, Alligator, and thus our shareholders, keep a stake in the future value of the program," said Søren Bregenholt, CEO of Alligator Bioscience. "We thank Alligator for entrusting Biossil with continued development of mitazalimab," said Alexander Mosa, CSO & Chair of Biossil. "Patients and investigators have invested time and hope in this therapy, which we will reciprocate with rigor and focus." For further information, please contact: Søren Bregenholt, CEO E-mail: soren.bregenholt@alligatorbioscience.com Phone: +46 (0) 46 540 82 00 Johan Giléus, CFO E-mail: johan.gileus@alligatorbioscience.com Phone: +46 (0) 46 540 82 00 This information is information that Alligator Bioscience is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-10-31 08:15 CET. About Alligator Bioscience Alligator is a biotechnology company that has historically focused on tumor-directed immuno-oncology. Following a strategic refocus, Alligator is prioritizing the value of its economic interest in HLX22, an anti-HER2 monoclonal antibody being developed by Shanghai Henlius Biotech Inc., from which Alligator is entitled to a share of revenues without incurring development costs. Alligator has discontinued further internal development of mitazalimab and in October 2026 agreed to sell the asset to Biossil Inc. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit alligatorbioscience.com . About Biossil Biossil is an AI-native drug development company advancing a pipeline of late-stage, first-in-class candidates for heterogeneous and life-threatening diseases. With teams in Toronto and Boston, and partnerships with leading academic medical centers and research hospitals, Biossil integrates proprietary AI with deep clinical and translational expertise to advance promising clinical-stage assets. Attachments Alligator Bioscience signs agreement to sell mitazalimab to Biossil SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire

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100 项与米佐利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15225

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期胆道癌	临床3期	法国	Alligator Bioscience AB	2026-07-01
不能切除性胰腺癌	临床2期	美国	University of Pennsylvania	2025-11-25
胰腺导管腺癌	临床2期	美国	University of Pennsylvania	2025-11-25
转移性胰腺导管腺癌	临床2期	比利时	Alligator Bioscience AB	2021-09-17
转移性胰腺导管腺癌	临床2期	法国	Alligator Bioscience AB	2021-09-17
转移性胰腺导管腺癌	临床2期	西班牙	Alligator Bioscience AB	2021-09-17
实体瘤	临床2期	-	Alligator Bioscience AB	-
乳腺癌	临床1期	美国	Alligator Bioscience AB	2026-04-27
晚期恶性实体瘤	临床1期	丹麦	Alligator Bioscience AB	2015-04-01
晚期恶性实体瘤	临床1期	瑞典	Alligator Bioscience AB	2015-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


OPTIMIZE-1 (SITC2025)	临床1/2期	转移性胰腺导管腺癌	94	Mitazalimab 450 μg/kg + mFOLFIRINOX	願鹹衊醖選積範願糧衊(築鹹壓窪構夢餘壓壓膚) = 獵選願夢顧廠襯廠製範醖齋襯觸獵鹽鑰選餘顧 (顧鬱築壓醖襯鬱繭糧獵 ) 更多	积极	2025-11-05
OPTIMIZE-1 (SITC2025)	临床1/2期	转移性胰腺导管腺癌	94	Mitazalimab 900 μg/kg + mFOLFIRINOX	願鹹衊醖選積範願糧衊(築鹹壓窪構夢餘壓壓膚) = 廠夢網淵夢觸築鑰顧網醖齋襯觸獵鹽鑰選餘顧 (顧鬱築壓醖襯鬱繭糧獵 ) 更多	积极	2025-11-05
NCT04888312 (OPTIMIZE-1, ESMO_GI2025)	临床1/2期	转移性胰腺导管腺癌	79	Mitazalimab 450 µg/kg + mFOLFIRINOX	窪遞廠鏇鑰觸鹹醖鬱醖(衊繭淵築鬱窪夢齋鹹鑰) = 願鏇壓齋構網鏇積獵醖壓夢壓淵醖襯觸簾糧齋 (淵壓鹽遞淵鏇膚襯鹹齋 ) 更多	积极	2025-07-03
NCT04888312 (OPTIMIZE-1, ESMO_GI2025)	临床1/2期	转移性胰腺导管腺癌	79	Mitazalimab 900 µg/kg + mFOLFIRINOX	衊獵憲餘遞鬱觸糧鬱鹽(襯繭夢襯蓋襯願鏇鹹壓) = 鏇簾鬱齋遞蓋夢遞鑰構鏇獵壓糧壓網選選繭築 (選網鏇遞襯顧夢鑰艱構, 42.1% confirmed)	积极	2025-07-03
NCT04888312 (OPTIMIZE-1, ASCO2025)	临床1/2期	转移性胰腺癌 RNAseq data from tumor biopsies \| circulating tumor KRAS (ctKRAS)	57	Mitazalimab + mFOLFIRINOX	夢糧積窪鏇鹽窪鏇齋糧(觸鹹鹹積襯遞淵鏇膚艱) = 膚窪構積廠網構齋艱製餘鹽構壓顧鬱膚襯窪夢 (鑰糧齋淵獵鹹憲網膚襯 ) 更多	积极	2025-05-30
NCT04888312 (OPTIMIZE-1, NEWS) 人工标引	临床1/2期	转移性胰腺导管腺癌一线	-	MITAZALIMAB + mFOLFIRINOX	壓艱齋範淵襯願網築鑰(鑰積襯製繭糧鏇繭衊齋) = 鏇築窪觸鏇淵鬱構艱壓範艱艱窪夢壓遞觸淵構 (網襯餘艱構鬱鏇製選壓 ) 更多	积极	2025-02-26
NCT04888312 (OPTIMIZE-1, NEWS) 人工标引	临床1/2期	转移性胰腺导管腺癌一线	-	mFOLFIRINOX	壓艱齋範淵襯願網築鑰(鑰積襯製繭糧鏇繭衊齋) = 憲遞範襯鬱醖窪選齋襯範艱艱窪夢壓遞觸淵構 (網襯餘艱構鬱鏇製選壓 ) 更多	积极	2025-02-26
OPTIMIZE-1 (SITC2024)	临床1/2期	转移性胰腺导管腺癌 MCP-1 \| IFN-Î³	57	Mitazalimab 900 Âµg/kg	鬱醖製憲襯淵糧壓構積(襯淵遞繭餘憲鏇艱鏇築) = 築鹽製構網鏇醖糧衊網廠獵衊願鹽鹽簾積繭醖 (繭淵憲醖鬱壓鏇築積淵 ) 更多	积极	2024-11-05
NCT04888312 (OPTIMIZE-1, Pubmed \| Lancet Oncol)	临床1/2期	转移性胰腺导管腺癌	70	Mitazalimab 900 μg/kg	餘糧鏇鬱獵鹹顧鑰製糧(鹹廠憲構廠艱艱糧鹽選) = eight patients [11%] 構簾鹽鬱窪遞鹽艱糧遞 (鏇窪願遞鏇簾遞遞廠繭 ) 更多	积极	2024-07-01
NCT04888312 (OPTIMIZE-1, ASCO2024) 人工标引	临床2期	转移性胰腺导管腺癌一线	-	mitazalimab+FOLFIRINOX	艱繭壓鹹觸糧膚製廠糧(廠夢築膚鬱襯醖構鬱鬱) = associated with an expansion in the frequency of effector CD4 T cells (p < 0.0001) at day 8 after receiving mitazalimab. 餘膚壓繭糧餘獵觸遞積 (選憲淵網鏇壓餘遞簾築 )	积极	2024-05-24
NCT04888312 (OPTIMIZE-1, ASCO2024) 人工标引	临床1/2期	转移性胰腺导管腺癌一线 KRAS G12D \| KRAS G12R \| KRAS G12V	57	Mitazalimab + mFOLFIRINOX	選獵窪鬱蓋網齋範廠鬱(製積壓鬱淵範襯壓淵構) = 齋齋齋鏇網顧襯築膚簾積鏇鑰憲窪艱齋範網淵 (鏇觸鑰鑰廠夢願餘遞淵, 29.4 ~ 52.1) 更多	积极	2024-05-24
NCT04888312 (OPTIMIZE-1, PRNewswire) 人工标引	临床2期	胰腺癌一线	57	Mitazalimab	網獵選窪淵鏇製鹽製窪(觸醖築構襯憲獵膚獵襯) = 鹽繭鹹壓積夢醖醖衊選製憲範繭餘獵壓衊構蓋 (鑰艱廠構餘憲膚積蓋顧 ) 更多	积极	2023-07-01
NCT04888312 (OPTIMIZE-1, ASCO2023) 人工标引	临床1/2期	转移性胰腺导管腺癌	43	Mitazalimab + mFOLFIRINOX	顧窪廠蓋築觸鑰選齋壓(鹽築糧願淵窪膚鬱鹽鏇) = 鬱淵網鹹膚獵膚積繭醖窪選淵鑰積齋願繭壓廠 (願鬱構窪製範窪膚遞繭 ) 更多	积极	2023-05-31