This is a phase I study of an agonistic CD40 antibody (mitazalimab) injected intratumorally at the time of surgical IRE in patients with locally advanced pancreatic cancer. Intratumoral delivery has potential to be more effective than systemic (intravenous) delivery while decreasing the systemic side effects of immunotherapy. We hypothesize that local delivery of mitazalimab at the time of IRE in patients with locally advanced pancreatic cancer will be safe, augment the immune effects of IRE, and decrease the risk of recurrence.

开始日期2024-06-25

申办/合作机构

University of California San Diego

[+2]

NCT04888312

/ Active, not recruiting临床1/2期

An Open-label Phase 1b/2 Study Assessing the Safety and Efficacy of Mitazalimab in Combination with Chemotherapy in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

Phase 1b/2 study to assess the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.

开始日期2021-09-17

申办/合作机构

Alligator Bioscience AB

[+2]

NL-OMON27591

/ RecruitingN/AIIT

Dendritic Cells loaded with allogeneic tumor lysate (MesoPher) in combination with a CD40 agonist (Mitazalimab) for metastatic pancreatic disease

开始日期2021-07-20

申办/合作机构-

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）

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

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: Richmond, Ann ; Zhou, Yang ; Yan, Chi

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.

2023-02-01·Investigational new drugs

A phase 1 study of intravenous mitazalimab, a CD40 agonistic monoclonal antibody, in patients with advanced solid tumors

Article

作者: Hellemans, Peter ; Peretz-Yablonski, Tamar ; Girgis, Suzette ; Calvo, Emiliano ; Pendás, Natalia ; Xia, Qi ; Guo, Yue ; Fourneau, Nele ; Perets, Ruth ; Verona, Raluca ; Moreno, Victor ; Geva, Ravit

Mitazalimab is an agonistic human monoclonal antibody targeting CD40, a target for anti-tumor immunotherapy. This phase 1, dose-escalation study evaluated the safety, dose-limiting toxicities (DLTs), pharmacokinetic and pharmacodynamic profile of mitazalimab. Adults with advanced solid malignancies received mitazalimab intravenously once every-2-weeks. Dose-escalation was pursued with and without pre-infusion corticosteroids for mitigation of infusion-related reactions (IRRs). In all, 95 patients were enrolled in 7 cohorts (n = 50, 75-2000 µg/kg) with corticosteroids and in 5 cohorts (n = 45, 75-1200 µg/kg) without corticosteroids. Two patients experienced DLTs (transient Grade-3 headache; Grade-3 drug-induced liver injury [Hy's law]). The most frequently reported (≥ 25%) treatment-emergent adverse events were fatigue (44.2%), pyrexia (38.9%), pruritus (38.9%), chills (27.4%), and headache (26.3%). IRRs were reported in 51.6% of patients; pruritus (30.5%; with corticosteroids [36.0%], without corticosteroids [24.4%]) was the most frequent. Following the first infusions of 600 μg/kg and 2000 μg/kg, mitazalimab was rapidly cleared from the systemic circulation with mean terminal half-life of 11.9 and 24.1 h, respectively. Pharmacokinetics appeared to exhibit target-mediated drug disposition at the tested doses. Mitazalimab treatment induced higher levels of selected chemokines and transient reduction of B-cells, T-cells, and NK cells. One patient (renal cell carcinoma) displayed partial response lasting 5.6 months. Stable disease was reported by 35 (36.8%) patients, persisting for ≥ 6 months in 9 patients. Mitazalimab has a manageable safety profile with acceptable pharmacokinetic and pharmacodynamic properties. Future clinical development will evaluate combination with existing treatment options. Trial registration NCT02829099 (ClinicalTrials.gov; July 7, 2016).

项与米佐利单抗相关的新闻（医药）

2025-02-27

·SYNAPSE

2025年2月27日全球新药进展早知道

1. Keytruda获FDA优先审评资格，针对头颈部鳞癌 2月25日，默沙东（MSD）宣布，美国FDA已接受该公司为重磅免疫疗法Keytruda递交的补充生物制品许可申请（sBLA），寻求批准Keytruda作为手术前的新辅助疗法，用于治疗可切除局部晚期头颈部鳞状细胞癌（LA-HNSCC）患者，随后联合标准放疗（有或无顺铂）作为辅助治疗，然后再作为单药进行辅助治疗。FDA同时授予这一申请优先审评资格，预计在今年6月23日之前完成审评。该sBLA基于3期临床试验KEYNOTE-689的积极数据，预先设定的首次中期分析结果将在即将召开的医学会议上公布。结果显示，在可切除LA-HNSCC患者中，包含Keytruda的围手术期治疗方案与单独采用辅助放疗（有或无顺铂）相比，在无事件生存期（EFS）方面具有统计学显著且临床意义重大的改善。 2. 阿斯利康下一代口服SERD一线乳腺癌III期研究成功 2月26日，阿斯利康宣布III期SERENA-6研究积极的中期分析结果，口服选择性雌激素受体降解剂（SERD）camizestrant联合CDK4/6抑制剂（palbociclib、ribociclib或abemaciclib）在无进展生存期（PFS）的主要终点方面显示出具有统计学意义和临床意义的改善。这意味着，camizestrant成为了首个也是唯一一个证明与已获批的CDK4/6抑制剂联用时具有一线治疗获益的新一代口服SERD和完全ER拮抗剂。SERENA-6研究评估了在一线治疗HR阳性、HER2阴性且具有ESR1突变晚期乳腺癌患者中，改用camizestrant组合疗法与继续使用芳香化酶抑制剂（阿那曲唑或来曲唑）联合CDK4/6抑制剂这一标准护理治疗的疗效与安全性比较。 3. 一周一次创新抗菌药在中国申报上市 2月26日，中国国家药监局药品审评中心（CDE）官网最新公示，由萌蒂制药（Mundipharma）申报的5.1类新药注射用醋酸瑞扎芬净的新药上市申请已获得受理。公开资料显示，瑞扎芬净（rezafungin）是一种环肽药物，是一种创新、一周一次的棘球白素（echinocandin），其已经于2023年3月获得美国FDA批准，用于治疗没有替代治疗选择或选择有限的念珠菌血症与侵袭性念珠菌病患者。瑞扎芬净最初由Cidara Therapeutics开发，萌蒂制药此前通过合作拥有rezafungin在美国和日本以外的商业权利。2024年4月，Cidara Therapeutics宣布将rezafungin的所有权利剥离给萌蒂制药。 4. Alligator更新CD40抗体胰腺癌2期临床数据，股价大涨90% 2月26日，Alligator Bioscience报告了CD40激动型抗体药物MITAZALIMAB（Mitazalimab，米佐利单抗）在胰腺癌的二期临床OPTIMIZE-1研究的最新结果。OPTIMIZE-1是一项开放标签、单臂、多中心的1b/2期临床试验，旨在评估Mitazalimab联合mFOLFIRINOX（改良FOLFIRINOX方案）作为一线治疗方案在转移性胰腺导管腺癌（mPDAC）患者中的疗效和安全性。数据显示，接受MITAZALIMAB单抗联用mFOLFIRINOX治疗的患者的24个月生存率为29.4%，中位总生存期 (mOS) 为14.9个月，显著优于FOLFIRINOX和最近的NALIRIFOX。基于这些结果和已确认的监管途径，Alligator Bioscience 仍在推进MITAZALIMAB单抗单抗进入确认性临床试验。受此消息推动，Alligator股价一度大涨100%以上。 5. 恒瑞ADC新药NSCLC研究结果荣登《柳叶刀·肿瘤学》 2月25日，由上海交通大学附属胸科医院陆舜教授以及李子明教授团队牵头开展的HORIZON-Lung研究II期阶段主要结果发表于国际肿瘤学领域顶级期刊《柳叶刀·肿瘤学》《The Lancet Oncology》（IF:41.6）。该研究结果显示，瑞康曲妥珠单抗（研发代号：SHR-A1811）单药用于既往经治HER2突变晚期非小细胞肺癌患者，表现出了令人鼓舞的抗肿瘤疗效及良好的安全性。HORIZON-Lung研究是一项开放性、多中心、剂量递增/拓展的I/II期临床试验。I期阶段旨在评估瑞康曲妥珠单抗在治疗HER2过表达、扩增或者突变的非小细胞肺癌（NSCLC）受试者中的安全性、耐受性、PK特征及有效性，II期阶段作为关键单臂研究，旨在评估瑞康曲妥珠单抗单药对HER2突变的晚期NSCLC受试者的抗肿瘤疗效和安全性，主要研究结果已于2024年9月递交上市申请且已被纳入优先审评。 6. Arrowhead公布ALK7 siRNA临床前结果，可增强替尔泊肽疗效 2月25日，Arrowhead Pharmaceuticals 公布了ARO-ALK7的临床前结果，这是一种靶向激活素受体样激酶7（ALK7）的在研RNA干扰（RNAi）疗法，有望成为治疗肥胖症的潜在疗法。ARO-ALK7是首个直接靶向脂肪组织中表达基因的RNAi疗法，目前已在新西兰启动ARO-ALK7的1/2a期临床试验，Arrowhead预计将于2025年第二季度开始给药。在啮齿动物和非人灵长类动物的临床前研究中，ARO-ALK7显示出脂肪组织中ALK7 mRNA表达的剂量依赖性和持久性降低。在饮食诱导的肥胖小鼠模型中的药理学研究表明，脂肪组织中ALK7的沉默导致身体成分改善，脂肪量减少约50%，同时保留了瘦体重。此外，GLP-1/GIP受体共激动剂替尔泊肽与ALK7 siRNA的联合治疗增强了治疗效果，与替尔泊肽单药治疗相比，在减轻体重和脂肪量方面具有叠加效应，同时缓解了替尔泊肽单药治疗相关的瘦体重显著减少。 1. 3.95亿美元！和铂医药就一款抗体新药达成授权合作 2月26日，和铂医药宣布，由其孵化的创新型生物技术公司HBM Alpha Therapeutics宣布与一家业务合作伙伴达成战略合作与许可协议，共同推进针对多种疾病的新型促肾上腺皮质激素释放激素（CRH）靶向疗法。根据协议，该合作伙伴获得在大中华区（包括中国大陆、中国台湾、中国香港和中国澳门地区）以外的全球市场开发和商业化HAT001（一款强效且选择性靶向CRH的中和抗体，和铂医药内部代号为HBM9013）的独家权利。HBMAT将获得高达3.95亿美元的总付款，包括首付款和开发、监管及商业里程碑付款，以及基于未来产品净销售额的分级特许权使用费。此外，HBMAT还有权获得认股权证以获取合作伙伴的少数股权。内容来源于网络，如有侵权，请联系删除。

优先审批临床结果临床成功

2024-12-17

·Business Wire

CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight Report 2025 - First CD40 Targeted Therapy Approval Expected By 2027 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2025" report has been added to ResearchAndMarkets.com's offering. CD40 targeted therapies have become a focal point in immunotherapy research, with growing attention on harnessing the potential of the CD40 receptor to treat a variety of diseases. While no CD40 targeted therapies have yet been approved for clinical use, some promising candidates are currently undergoing late stage clinical development. Moreover, additional candidates are slated to enter late-stage trials within the next year, expanding the pool of CD40 targeted therapies in clinical development. These ongoing research and clinical trials suggest that CD40 targeted therapies could become a vital treatment option for patients with prevalent diseases in the coming years. Global CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2025 Report Highlights: First CD40 Targeted Therapy Approval Expected By 2027 CD40 Targeted Therapies In Clinical Trials: > 20 Therapies CD40 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase CD40 Targeted Therapy Research & Development Trends By Indication CD40 Targeted Therapy Market Trend Analysis By Region CD40 Targeted Therapies Proprietary Technologies By Company Historically, the primary focus of CD40 targeted therapies has been on autoimmune and inflammatory diseases. However, there is an increasing interest in exploring their potential for treating cancer and other conditions. More recent studies have expanded the scope of CD40 targeting to include infectious diseases, such as HIV and COVID-19, as well as neurodegenerative diseases like Alzheimer's and Parkinson's disease. Some research has also suggested that CD40 targeted therapies might be beneficial for diseases like cardiovascular conditions, where CD40's signaling pathway, although not directly involved in disease initiation, plays a role in disease progression and inflammation. Over the years, various strategies have been employed to target the CD40 receptor and its ligand. These include traditional monoclonal antibodies as well as next-generation molecular therapeutics such as small interfering RNA (siRNA). While antibodies are developed either as CD40 agonists or as antagonists, CD40 targeted siRNAs aim to reduce CD40 protein expression by degrading CD40 mRNA. Several other conventional and next-generation approaches are undergoing active research and clinical trials to assess their safety and efficacy. Nonetheless, antibody therapies remain the dominant approach in CD40 targeted research. Among the most advanced CD40/CD40L targeted antibodies are those for autoimmune and inflammatory diseases, with some entering phase 3 clinical trials. For example, Sanofi's Frexalimab, a promising anti CD40 antibody, is currently in phase 3 trials for autoimmune conditions. In the cancer domain, CD40 targeted antibodies are also making significant strides, with companies like Alligator Bioscience preparing to initiate phase 3 clinical trials for its lead candidate, mitazalimab, an anti-CD40 antibody for pancreatic ductal adenocarcinoma (PDA) and pancreatic cancer. The development of CD40 targeted therapies has been greatly facilitated by the advent of proprietary technologies and platforms. One notable example is GenMab's DuoBody platform, which enables the creation of bispecific antibodies that can target two different antigens simultaneously. This technology has been leveraged to develop several promising immunotherapies, including its CD40 targeted therapy, GEN1042/BNT312, currently in phase 2 trial for malignant solid tumors. As the field of CD40 targeted therapies evolves, the competitive landscape is becoming increasingly crowded, with many major pharmaceutical companies entering the arena. Notable players include Amgen, Sanofi, GenMab, BioNTech, and Biogen, all of which are investing heavily in this space. Collaborations between pharmaceutical companies and academic institutions have been essential in advancing the scientific understanding of CD40 targeted therapies, combining cutting edge research with clinical expertise to bring these therapies closer to market. In conclusion, while CD40 targeted therapies have not yet been approved for clinical use, they represent a promising and rapidly developing area of research across a wide range of diseases. As more therapies enter clinical trials and the competitive landscape intensifies, it is clear that CD40 targeted therapies could become a cornerstone of treatment for cancer, autoimmune diseases, infectious diseases, and beyond in the near future. Key Topics Covered: Introduction To CD40 Targeted Therapies Considering CD40 As Drug Target Over Other CD Markers History & Evolution Of CD40 Targeting Therapies CD40 Targeted Therapies - Mechanism Of Action Agonist Mediated Activation Of CD40 Signaling Antagonist-Mediated Inhibition Of CD40 Signaling CD40 Targeted Therapeutic Approaches Antibody Formats Fusion Proteins Peptides Nucleic Acids CD40 Targeted Therapy Research & Development Trends By Indication Cancer Neurological Diseases Autoimmune & Inflammatory Disorders Transplant Rejection Microbial Infections Global CD40 Targeted Therapy Market Outlook Current Market Trends & Developments Future Market Opportunities CD40 Targeted Therapy Market Trend Analysis By Region US Europe China Japan Australia CD40 Targeted Therapies Clinical Trials Insight By Company, Country, Indication & Phase Research Preclinical Phase I Phase I/II Phase II Phase III CD40 Targeted Therapies - Proprietary Technologies By Company Alligator Bioscience - FIND Technology & Neo-X-Prime Aprilbio - SAFA Platform Biocytogen - RenMice EnnoDC - Unnamed Platform Genmab - DuoBody Harbour BioMed - Harbour Mice & HBICE Kyowa Kirin - REGULGENT Strike Pharma - ADAC Technology Platform Global CD40 Targeted Therapy Market Dynamics Competitive Landscape Alligator Bioscience Amgen Biogen BioNTech Eledon Pharmaceuticals EnnoDC Genmab Innovent Bio Novartis Sanofi Tonix Pharmaceuticals UCB For more information about this report visit https://www.researchandmarkets.com/r/46sm5e About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

免疫疗法临床3期临床2期

2024-12-13

·access wire

Last Day of Trading in Warrants Series TO 9 in Alligator Bioscience AB is 13 December 2024

LUND, SE / ACCESSWIRE / December 13, 2024 / Alligator Bioscience (STO:ATORX) 13 December 2024 is the last day of trading in warrants series TO 9 in Alligator Bioscience AB ("Alligator Bioscience" or the "Company"). Subscription of ordinary shares by exercise of warrants series TO 9 is ongoing until 18 December 2024. One (1) warrant series TO 9 entitles the holder to subscribe for one (1) new ordinary share in the Company at a subscription price of SEK 0.55 per share.During March - April 2024, Alligator Bioscience carried out a rights issue of units (the " Rights Issue "). Each unit issued in the Rights Issue consisted of one (1) ordinary share and one (1) warrant series TO 9. One (1) warrant series TO 9 entitles the holder to subscribe for one (1) new ordinary share in the Company. Upon full exercise of all warrants, Alligator Bioscience will receive approximately SEK 55.0 million before issue costs. 13 December 2024 is the last day of trading in warrants series TO 9.Complete terms and conditions for the warrants are available on the Company's website, www.alligatorbioscience.com .Summarized terms for warrants series TO 9Exercise period : 4 December 2024 - 18 December 2024.Subscription price : SEK 0.55 per share. The subscription price corresponds to 90 per cent of the volume-weighted average price of the Company's ordinary share on Nasdaq Stockholm during the period 4 - 29 November 2024.Issue volume : 100,084,946 warrants series TO 9. For each warrant series TO 9, the holder can subscribe for one (1) new ordinary share in the Company. If all warrants are exercised, 100,084,946 ordinary shares will be issued, which will provide the Company with approximately SEK 55.0 million before issue costs.Last day of trading in warrants series TO 9 : 13 December 2024.Share capital and dilution : Upon full exercise of all 100,084,946 warrants series TO 9, the share capital will increase by a maximum of SEK 80,067.9568 to SEK 687,259.2256 through the issuance of a maximum of 100,084,946 new ordinary shares, resulting in that the total number of outstanding shares in the Company will increase from 758,989,086 to 859,074,032, whereof 858,294,863 are ordinary shares and 779,169 are series C shares. Upon full exercise of all warrants series TO 9, the dilution of the ordinary shares amounts to approximately 11.7 per cent. The total number of votes in the Company will, following full exercise of all warrants TO 9, amount to 858,372,779.9.Please note that the warrants series TO 9 that are not exercised by 18 December 2024, or sold by 13 December 2024, will expire without value. In order for the warrants not to lose their value, active subscription of shares or sale of warrants is required. Please note that some nominees may close their application earlier than 18 December 2024.AdvisersVator Securities AB acts as Sole Global Coordinator and bookrunner in connection with the Rights Issue and Van Lanschot Kempen N.V. acts as financial adviser to Alligator Bioscience in connection with the Rights Issue. Setterwalls Advokatbyrå AB is legal adviser to Alligator Bioscience in connection with the Rights Issue. Vator Securities AB acts as the issuing agent in connection with the Rights Issue.For further information, please contact:Søren Bregenholt, CEOE-mail: [email protected]Phone: +46 (0) 46 540 82 00The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on December 13, 2024.About Alligator BioscienceAlligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. Its portfolio includes lead drug candidate mitazalimab, for which the company reported unprecedented survival data at 18-months follow up in first-line metastatic pancreatic cancer patients in Phase 2 testing and is in preparation for Phase 3 development. The follow-on bispecific antibody ATOR-4066 is in preclinical testing. Alligator has a proprietary technology platform, comprised of two antibody libraries, ALLIGATOR-GOLD® and ALLIGATOR-FAB™, the powerful protein optimization strategy FIND® and the bispecific antibody format RUBY™, which drives rapid design and development of innovative drugs.Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.For more information, please visit alligatorbioscience.com .IMPORTANT INFORMATIONThe information in this press release does not contain or constitute an offer to acquire, subscribe for or otherwise trade in shares, warrants or other securities in Alligator. The invitation to the persons concerned to subscribe for units consisting of shares and warrants in Alligator has only been made through the prospectus published by Alligator on 15 March 2024, and through the supplement prospectus published by Alligator on 22 March 2024. The prospectuses have been approved and registered by the Swedish Financial Supervisory Authority and have been published on the Company's website, www.alligatorbioscience.com .Since Alligator Bioscience conducts essential services according to the Swedish Screening of Foreign Direct Investments Act ( Sw. lag (2023:560) om granskning av utländska direktinvesteringar), the exercise of warrants for subscription of ordinary shares may require review by the Inspectorate of Strategic Products (ISP). The Company will, no later than in connection with the commencement of the exercise period for the warrants, publish more information about this on the Company's website, www.alligatorbioscience.com .AttachmentsLast day of trading in warrants series TO 9 in Alligator Bioscience AB is 13 December 2024SOURCE: Alligator Bioscience

临床2期

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
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
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
晚期恶性实体瘤	临床1期	英国	Alligator Bioscience AB	2015-04-01

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临床结果

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分期

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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


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	選築簾衊遞顧顧選鏇鹽(醖窪築夢願膚憲窪鏇觸) = 窪鹽夢膚鹽範構艱鏇積觸壓鹹積觸積夢獵鹽鹽 (憲餘選餘餘網夢餘鏇壓 ) 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	選築簾衊遞顧顧選鏇鹽(醖窪築夢願膚憲窪鏇觸) = 鑰範醖簾糧艱襯鹹窪醖觸壓鹹積觸積夢獵鹽鹽 (憲餘選餘餘網夢餘鏇壓 ) 更多	积极	2025-02-26
NCT04888312 (OPTIMIZE-1, Pubmed)	临床1/2期	转移性胰腺导管腺癌	70	Mitazalimab 900 μg/kg	醖鹽憲築願壓醖糧蓋鬱(願網築艱網衊顧顧鏇網) = eight patients [11%] 遞遞醖廠築襯遞積遞廠 (鑰糧襯築構窪蓋觸餘夢 ) 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	壓淵餘鏇鹽選選淵膚網(壓選糧製齋醖鏇鏇餘範) = associated with an expansion in the frequency of effector CD4 T cells (p < 0.0001) at day 8 after receiving mitazalimab. 衊選夢鑰淵衊鬱襯鬱夢 (糧繭齋壓構製醖壓淵糧 )	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	築艱淵製蓋衊獵製淵襯(糧蓋窪糧膚築鏇積鬱膚) = 襯鹽蓋範範鬱蓋鏇繭廠鑰範繭獵衊簾艱鑰遞顧 (製窪鹹鹽鬱淵衊繭鑰憲, 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	廠鑰製鹹蓋鹹鬱繭選餘(夢鹽鬱淵製遞獵艱築蓋) = 積廠廠鹽網鏇夢積鹽觸積觸繭壓壓壓顧醖網淵 (築繭糧繭鬱糧憲壓膚範 ) 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	廠遞構選醖願齋鏇醖鬱(餘顧鏇窪選壓鏇遞願醖) = 膚鑰簾艱鹽糧網範鹽觸廠構夢壓鑰淵簾製壓願 (廠鏇製鏇憲積願鏇觸膚 ) 更多	积极	2023-05-31
NCT04888312 (OPTIMIZE-1, PipelineReview) 人工标引	临床2期	转移性胰腺癌一线	23	mFOLFIRINOX+Mitazalimab	獵夢衊網積願鑰簾繭遞(襯膚憲構廠鑰鑰廠糧遞) = 膚願願鹹遞夢遞遞窪鹹廠淵鏇遞襯衊壓襯網夢 (憲淵鑰鑰醖膚壓鹹壓糧 ) 更多	积极	2023-01-02
NCT02829099 (Pubmed)	临床1期	晚期恶性实体瘤	95	Mitazalimab	淵簾範繭繭鬱願鬱網選(糧顧鏇艱鹹糧獵襯鑰網) = 艱夢積廠願顧獵夢艱餘蓋廠鬱艱衊夢獵蓋淵襯 (鑰餘鬱鹽鑰鏇夢鹹廠鬱 ) 更多	-	2022-12-20
NCT04888312 (OPTIMIZE-1, AACR2022) 人工标引	临床1/2期	转移性胰腺导管腺癌一线	11	Mitazalimab+mFOLFIRINOX	淵壓膚夢廠膚淵艱遞觸(顧廠願網鏇築鹹願顧齋) = 蓋齋衊衊膚夢壓網淵壓製選範願艱觸願鹹鏇壓 (鹽廠積鏇憲膚鑰繭鬱選 ) 更多	积极	2022-11-15
NCT04888312 (OPTIMIZE-1, ASCO2022) 人工标引	临床1期	转移性胰腺导管腺癌	5	mFOLFIRINOX+Mitazalimab	網糧築壓鬱襯夢糧積願(蓋觸繭製選獵鹽膚膚獵) = 遞膚積鬱築蓋餘襯餘鑰憲膚餘廠鏇膚廠鹽獵遞 (願窪鑰顧衊膚餘膚鹹選 ) 更多	积极	2022-06-02