A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma

Urothelial carcinoma (UC) is the ninth most common cancer type worldwide. While the treatment of front-line metastatic urothelial carcinoma (mUC) has improved, there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab.
Livmoniplimab is an investigational drug being developed for the treatment of mUC. There are 3 treatment arms in this study and participants will be randomized in a 1:1:1 ratio. Participants will either receive livmoniplimab (at one of 2 different doses) in combination with budigalimab (another investigational drug), or either docetaxel, paclitaxel, or gemcitabine (based on investigator's choice). Approximately 150 adult participants will be enrolled in the study across 56 sites worldwide.
In arm 1, participants will receive intravenously (IV) infused livmoniplimab (dose A) in combination with IV infused budigalimab. In arm 2, participants will receive IV infused livmoniplimab (dose B) in combination with IV infused budigalimab. In arm 3 (control), participants will receive the investigator's choice: IV infused or injected docetaxel; IV infused or injected paclitaxel; or IV infused gemcitabine. The estimated duration of the study is up to approximately 3.5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

开始日期2024-12-31

申办/合作机构

AbbVie, Inc.

NCT06628310 / Not yet recruiting临床2期

A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977)

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Leucovorin, and a programmed cell death receptor 1 (PD1) inhibitor (Budigalimab) (AFLB) to adult participants to treat locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEA).
ABBV-400 and Budigalimab are investigational drugs being developed for the treatment of mGEA. Fluorouracil and Leucovorin are drugs approved for the treatment of mGEA. This study will be divided into two stages, with the first stage treating participants with increasing doses of ABBV-400 within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into groups called treatment arms where one group will receive fluorouracil, leucovorin, and oxaliplatin (FOLFOX). A further two treatment groups will receive AFLB, but with two optimized doses of ABBV-400 to allow for the best dose to be studied in the future. Approximately 180 adult participants with mGEA will be enrolled in the study in 51 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of ABBV-400 within the AFLB regimen until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive AFLB, but with one of two optimized doses of ABBV-400The study will run for a duration of approximately 6 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

开始日期2024-12-08

申办/合作机构

AbbVie, Inc.

NCT06487559 / Recruiting临床1期

A Phase 1b Study to Evaluate the Safety and Pharmacokinetics of Livmoniplimab in Combination With Budigalimab in Chinese Subjects With Locally Advanced or Metastatic Child-Pugh A Hepatocellular Carcinoma Who Have Progressed After a First-Line Regimen That Includes an Immune Checkpoint Inhibitor

Hepatocellular carcinoma (HCC) is a common cancer worldwide and a leading cause of cancer-related death. The majority of participants first presenting with HCC have advanced unresectable or metastatic disease. The purpose of this study is to assess adverse events and how livmoniplimab in combination with budigalimab moves through the body in adult Chinese participants with Locally Advanced or metastatic Child-Pugh A Hepatocellular Carcinoma (HCC).
Livmoniplimab is an investigational drug being developed for the treatment of HCC. There are 2 stages to this study. Stage 1 is a safety run-in. There are 2 treatment arms in stage 1 and participants will receive escalating doses of Livmoniplimab in combination with budigalimab (fixed dose). Stage 2 is dose expansion. There are 2 treatment arms in stage 2 and participants will receive Livmoniplimab in combination with budigalimab in multiple doses. Approximately 20 adult participants will be enrolled in the study across 15 sites in China.
In part 1 (dose escalation), participants will be intravenously infused with escalating doses of livmoniplimab in combination with budigalimab every 3 weeks. In part 2 (dose expansion), participants will be intravenously infused with livmoniplimab in combination with budigalimab in multiple doses every 3 weeks. The estimated duration of the study is up to 2 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

开始日期2024-09-11

申办/合作机构

AbbVie, Inc.

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100 项与布格利单抗相关的专利（医药）

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项与布格利单抗相关的文献（医药）

2022-10-01·Annals of Oncology

Circulating L-arginine predicts the survival of cancer patients treated with immune checkpoint inhibitors

Article

作者: Even, C ; Barlesi, F ; Italiano, A ; Fontan, L ; Danlos, F-X ; Bessede, A ; Cousin, S ; Le Loarer, F ; Soria, J-C ; Khettab, M ; Nafia, I ; Chaput, N ; Tselikas, L ; Peyraud, F ; Bodet, D ; Roubaud, G ; Chomy, F ; Marabelle, A ; Auzanneau, C ; Planchard, D ; Besse, B ; Cabart, M ; Guégan, J-P

BACKGROUNDThe discovery of immune checkpoint inhibitors (ICIs) has revolutionized the systemic approach to cancer treatment. Most patients receiving ICIs, however, do not derive benefits. Therefore, it is crucial to identify reliable predictive biomarkers of response to ICIs. One important pathway in regulating immune cell reactivity is L-arginine (ARG) metabolism, essential to T-cell activation. We therefore aimed to evaluate the association between baseline plasma ARG levels and the clinical benefit of ICIs.PATIENTS AND METHODSThe correlation between ARG levels and clinical ICI activity was assessed by analyzing plasma samples obtained before treatment onset in two independent cohorts of patients with advanced cancer included in two institutional molecular profiling programs (BIP, NCT02534649, n = 77; PREMIS, NCT03984318, n = 296) and from patients in a phase 1 first-in-human study of budigalimab monotherapy (NCT03000257). Additionally, the correlation between ARG levels and ICI efficacy in preclinical settings was evaluated using a syngeneic mouse model of colorectal cancer responsive to ICIs. Using matched peripheral blood mononuclear cell (PBMC) plasma samples, we analyzed the correlation between ARG levels and PBMC features through multiplexed flow cytometry analysis.RESULTSIn both discovery and validation cohorts, low ARG levels at baseline (<42 μM) were significantly and independently associated with a worse clinical benefit rate, progression-free survival, and overall survival. Moreover, at the preclinical level, the tumor rejection rate was significantly higher in mice with high baseline ARG levels than in those with low ARG levels (85.7% versus 23.8%; P = 0.004). Finally, PBMC immunophenotyping showed that low ARG levels were significantly associated with increased programmed death-ligand 1 expression in several immune cell subsets from the myeloid lineage.CONCLUSIONSWe demonstrate that baseline ARG levels predict ICI response. Plasma ARG quantification may therefore represent an attractive biomarker to tailor novel therapeutic regimens targeting the ARG pathway in combination with ICIs.

2022-04-01·Journal of Immunotherapy4区 · 医学

Association of Baseline and Pharmacodynamic Biomarkers With Outcomes in Patients Treated With the PD-1 Inhibitor Budigalimab

4区 · 医学

Article

作者: Turan, Tolga ; Afar, Daniel ; Vosganian, Greg ; Zhang, Chun ; Sheridan, James ; Lambert, Stacie L. ; Masica, David L. ; Fang, Yuni ; McLaughlin, Robert Tyler ; Tribouley, Catherine ; Guo, Claire ; Englert, Stefan

Budigalimab, a novel anti–PD-1 monoclonal antibody, demonstrated efficacy and biomarker pharmacodynamics in patients with head and neck squamous cell carcinoma (HNSCC) or non–small cell lung cancer (NSCLC) consistent with those reported by other PD-1 inhibitors. Herein are presented additional outcomes of biomarker analyses from the phase 1 study of budigalimab monotherapy in patients with HNSCC and NSCLC (NCT03000257). PD-1 inhibitor naive patients with advanced HNSCC (n=41) or NSCLC (n=40) received budigalimab intravenously at 250 mg every 2 weeks (Q2W) or 500 mg Q4W until progression. Archival tumor specimens were evaluated by immunohistochemistry for CD8 and tumor PD-1 ligand 1 (PD-L1) expression, RNA, and whole-exome sequencing. Serum and whole blood samples were acquired at baseline and at select on-treatment time points. As of October 2019, best overall response of 15% in HNSCC and 18% in NSCLC was observed in all treated patients; both cohorts reported responses in PD-L1+ and PD-L1– tumors. Treatment with budigalimab was associated with increases in multiple soluble biomarkers including interferon gamma-induced chemokines. Expanded overall T-cell counts, total CD8 T-cell counts, and percentages of CD8+CD45RA–CD62L– effector memory T cells were observed at cycle 1, day 15 in responders. Univariate analysis demonstrated an association between prolonged progression-free survival and higher tumor mutational burden/neoantigen load, smaller tumor size, lower platelet-lymphocyte ratios, lower CCL23, lower colony-stimulating factor 1, and lower interleukin-6 levels at baseline. The biomarker analysis presented herein identified additional early pharmacodynamic biomarkers associated with anti–PD-1 activity and improved clinical responses to budigalimab in patients with advanced HNSCC and NSCLC.

2022-02-01·Cancer Immunology, Immunotherapy2区 · 医学

First-in-human phase 1 study of budigalimab, an anti-PD-1 inhibitor, in patients with non-small cell lung cancer and head and neck squamous cell carcinoma

2区 · 医学

Article

作者: Italiano, Antoine ; Gao, Bo ; Millward, Michael ; Alanko, Tuomo ; Shiah, Her-Shyong ; Tosi, Diego ; Cassier, Philippe A ; Moreno, Victor ; Lambert, Stacie ; Tanner, Minna ; Roda, Desamparados ; Peltola, Katriina J ; Warburton, Lydia ; Afar, Daniel E ; Parikh, Apurvasena ; Cervantes, Andrés ; Calvo, Emiliano ; Englert, Stefan ; Lin, Chia-Chi ; Gazzah, Anas ; Vosganian, Gregory

AbstractBackgroundBudigalimab is a humanized, recombinant immunoglobulin G1 monoclonal antibody targeting programmed cell death protein 1 (PD-1). We present the safety, efficacy, pharmacokinetic (PK), and pharmacodynamic data from patients enrolled in the head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) expansion cohorts of the phase 1 first-in-human study of budigalimab monotherapy (NCT03000257; registered 15 December 2016).Patients and methodsPatients with recurrent/metastatic HNSCC or locally advanced/metastatic NSCLC naive to PD-1/PD-1-ligand inhibitors were enrolled; patients were not selected on the basis of oncogene driver mutations or PD-L1 status. Budigalimab was administered at 250 mg intravenously Q2W or 500 mg intravenously Q4W until disease progression/unacceptable toxicity. The primary endpoints were safety and PK; the secondary endpoint was efficacy. Exploratory endpoints included biomarker assessments.ResultsIn total, 81 patients were enrolled (HNSCC: N = 41 [PD-L1 positive: n = 19]; NSCLC: N = 40 [PD-L1 positive: n = 16]); median treatment duration was 72 days (range, 1–617) and 71 days (range, 1–490) for the HNSCC and NSCLC cohorts, respectively. The most frequent grade ≥ 3 treatment-emergent adverse event was anemia (HNSCC: n = 9, 22%; NSCLC: n = 5, 13%). Both dosing regimens had comparable drug exposure and increased interferon gamma-induced chemokines, monokine induced by gamma interferon, and interferon-gamma-inducible protein 10. Objective response rates were 13% (90% CI, 5.1–24.5) in the HNSCC cohort and 19% (90% CI, 9.2–32.6) in the NSCLC cohort. Median progression-free survival was 3.6 months (95% CI, 1.7–4.7) and 1.9 months (95% CI, 1.7–3.7) in the HNSCC and NSCLC cohorts.ConclusionsThe safety, efficacy and biomarker profiles of budigalimab are similar to other PD-1 inhibitors. Development of budigalimab in combination with novel anticancer agents is ongoing.

项与布格利单抗相关的新闻（医药）

2024-09-16

·PRNewswire

Trishula Therapeutics Presents Positive Results from Phase 1 Trial of TTX-030 in First-Line Metastatic Pancreatic Cancer Patients

Results presented at ESMO Congress 2024 SOUTH SAN FRANCISCO, Calif., Sept. 16, 2024 /PRNewswire/ -- Trishula Therapeutics, Inc., a clinical stage, privately held biotechnology company, today reported final results from a Phase 1 trial of TTX-030, a potential first-in-class, anti-CD39 antibody, in patients with first-line metastatic pancreatic cancer. Results were presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. "The Phase 1 results demonstrated a strong median overall survival in patients with metastatic pancreatic cancer following treatment with TTX-030 combinations as well as marked benefit in those with high levels of tumor HLA-DQ biomarker expression," said Anil Singhal, Chief Executive Officer of Trishula Therapeutics. "These findings have led to our currently enrolling global, randomized Phase 2 ELTIVATE study with results expected in 2026." The Phase 1 trial evaluated TTX-030 in combination with gemcitabine/nab-paclitaxel, with or without budigalimab (an investigational anti-PD-1 antibody), as first-line treatment for pancreatic adenocarcinoma. In the efficacy-evaluable population (n=57) consisting of 92% first-line metastatic and 8% locally advanced nonresecetable patients, the objective response rate (ORR) was 30%, with 3 complete responses; the median progression free survival (mPFS) was 7.5 months (95%CI 5.2, 9.4); and median overall survival was 19.1 months (9.8, NR). Analysis of pre-treatment tumor biopsies identified a subset of patients with a high expression of an immune-associated biomarker, HLA-DQ (HLA-DQhigh) and favorable clinical outcomes with TTX-030 combinations. Of the 28 HLA-DQhigh patients, the ORR was 46%, mPFS was 9.6 months (95% CI 3.9, 11.8), and mOS of 21.9 months (9.8, NR). Both treatment combinations were well-tolerated, with only five patients (8%) discontinuing treatment due to adverse events (AEs). The most frequent AEs were those expected from the standard of care chemotherapy backbone without an increase in frequency or severity. "Prior evaluation of immune checkpoint treatment has demonstrated limited benefit in this patient population and new approaches are needed. These results are very encouraging, especially in the biomarker high patients and warrant further investigation of TTX-030 for patients with advanced pancreatic cancer," said Zev Wainberg, MD, Professor of Medicine, UCLA. TTX-030 is currently being evaluated as first-line treatment for metastatic pancreatic adenocarcinoma in the global Phase 2 ELTIVATE trial (NCT06119217) that is randomizing approximately 180 patients into three study arms: TTX-030 and chemotherapy (gemcitabine and nab-paclitaxel); TTX-030 plus budigalimab and chemotherapy; or chemotherapy alone. The primary endpoint of the trial is progression-free survival (PFS) in a biomarker-enriched (HLA-DQhigh) population. Secondary endpoints include PFS in the overall population, safety, objective response rate, duration of response and overall survival. Further information on the study can be found at (clinicaltrials.gov link). About TTX-030 TTX-030 is a potential first-in-class, anti-CD39 antibody designed to inhibit the activity of CD39, an enzyme that converts adenosine triphosphate (ATP) to adenosine monophosphate (AMP), the initial step in the generation of adenosine in the tumor microenvironment. TTX-030 prevents the formation of immune-suppressive extracellular adenosine and maintains high levels of immune-activating extracellular ATP, stimulating dendritic and myeloid-derived cells promoting both innate and adaptive anti-tumor immunity. Trishula is continuing to develop TTX-030 in collaboration with AbbVie Inc. About Trishula Trishula is a privately held biotechnology company dedicated to the development of TTX-030. For more information, please visit . Media Contact: Julie Rathbun Rathbun Communications [email protected] 206-769-9219 SOURCE Trishula Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床2期临床1期免疫疗法

2024-07-29

·医药观澜

艾伯维抗艾滋病1类新药在中国获批临床

7月29日，中国国家药监局药品审评中心（CDE）官网公示，艾伯维（AbbVie）1类新药ABBV-382注射液获批临床，拟开发用于在不联合抗逆转录病毒疗法（ART）的情况下持续抑制免疫介导的HIV（HIV血浆病毒载量处于不可检出的水平）。公开资料显示，ABBV-382是一种α4β7整合素单克隆抗体，全球处于2期临床阶段，此次是这款在研新药在中国首次获批临床。截图来源：CDE官网 α4β7整合素在HIV-1感染的发病机制中起重要作用，这是一种异二聚体受体，在不同的免疫细胞上表达。α4β7在外周血CD4+T细胞中的表达可预测HIV-1获得和疾病进展。研究发现，α4β7存在于HIV-1病毒粒子的包膜上，这表明α4β7可能是HIV-1治疗的一个高度保守的靶点。公开资料显示，ABBV-382可通过直接拮抗α4β7与其同源配体MAdCAM-1或HIV-1 gp120的相互作用，从而抑制HIV-1复制/细胞间传播。此外，ABBV-382还能结合HIV-1病毒粒子中的α4β7形成免疫复合物（ICs）。这些ICs可以结合抗原呈递细胞上表达的fcgr，增强病毒抗原向T细胞的呈递，通过直接拮抗α4β7与其同源配体MAdCAM-1或HIV-1 gp120的相互作用，潜在地诱导免疫反应来控制病毒复制/细胞间传播。临床前研究结果表明，ABBV-382表现出良好的生物学特性和新的机制特性，支持其作为HIV-1病毒控制的基于免疫的干预措施。根据艾伯维官网，该公司正在开发ABBV-181 (budigalimab，抗PD-1）和ABBV-382的组合（研发代号：ABBV-1882），正在研究作为一种抗逆转录病毒治疗(ART)的HIV病毒控制方案，目前处于2期临床阶段。艾滋病是由于HIV感染引起的严重疾病，HIV主要有两种亚型，即HIV-1和HIV-2。相对来讲，HIV-1的复制能力更强，感染传播几率更高。HIV感染人体后，会侵犯免疫系统，包括CD4+T淋巴细胞、单核巨噬细胞和树突状细胞等，主要表现为CD4+T淋巴细胞数量不断减少，最终导致人体细胞免疫功能缺陷，引起各种机会性感染和肿瘤的发生。艾滋病曾经被认为是无药可治的致命疾病。随着上世纪末鸡尾酒疗法的建立，艾滋病已经成为可控的慢性疾病。尽管目前的疗法还不能够完全治愈HIV感染，但可以显著降低患者体内病毒数量，维持患者免疫功能，并且防止HIV病毒传播患者能够达到与普通人相当的预期寿命。参考资料： [1]中国国家药监局药品审评中心（CDE）官网.Retrieved Jul 29，2024,from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d [2] ABBV-382, an Anti-α4β7 Ab That Enhances HIV-1 Antigen Presentation for Immune-Mediated Viral Control.Retrieved Jul 29,2024,from https://www.croiconference.org/abstract/abbv-382-an-anti-%ce%b14%ce%b27-ab-that-enhances-hiv-1-antigen-presentation-for-immune-mediated-viral-control/ 内容来源于网络，如有侵权，请联系删除。

临床1期免疫疗法

2024-07-29

·凯莱英药闻

艾伯维：差异化布局整合素α4β7，旨在功能性治愈HIV！“同类首创”ABBV-382注射液在国内获批临床

欢迎关注凯莱英药闻今日，中国国家药监局药品审评中心（CDE）官网公示，艾伯维（“AbbVie”）的ABBV-382注射液获批临床，拟用于在不联合抗逆转录病毒疗法（ART）的情况下，持续抑制免疫介导的HIV（HIV血浆病毒载量处于不可检出的水平）。关于ABBV-382 ABBV-382是一款靶向整合素α4β7单克隆抗体，通过直接拮抗α4β7与其同源配体黏膜地址素细胞粘附分子1 (MAdCAM-1)或HIV-1 gp120的相互作用，从而抑制HIV-1复制/细胞间传播；此外，该药物能结合HIV-1病毒粒子中的α4β7形成免疫复合物（ICs），ICs可结合抗原呈递细胞上表达的fcgr，增强病毒抗原向T细胞的呈递。临床前研究表明，ABBV-382具有良好的生物学特性和新机制特性，支持其作为一种控制HIV-1病毒的干预措施。目前，该药物正在开展一项II期试验，与PD-1抑制剂ABBV-181 (budigalimab)联用，评估其在接受稳定抗逆转录病毒治疗并中断的HIV感染者中的疗效、安全性、耐受性和药代动力学；目前处于招募阶段。关于α4β7药物整合素是一种跨膜蛋白，能使细胞粘附在周围环境中，并在细胞信号传导中发挥作用；研究发现，有三种不同的整合素亚基与白细胞迁移到消化道有关，即α2β2、α4β1、α4β7。整合素阻断剂专门用于阻止白细胞上的这些亚基与消化道血管上的MAdCAM-1受体结合，防止白细胞迁移到消化道，从而将炎症降至最低。 HIV 侵入机体后首先感染肠道相关淋巴组织（GALT）中的CD4 细胞，CD4 细胞大量丢失，继而导致肠黏膜完整性破坏，肠道微生物进入血液，引发慢性免疫活化和炎症。肠道归巢细胞是CD4细胞的一个亚群，表达归巢受体整合素α4β7，具有记忆表型，其配体为存在于肠系膜淋巴结高内皮静脉和肠固有层的黏膜地址素细胞黏附分子（MAdCAM）；α4β7与MAdCAM 结合，引导外周血CD4细胞归巢至肠道，发挥免疫功能。另一方面，α4β7 CD4细胞高表达HIV 辅受体CCR5，且HIV gp120 V2 环的一段保守序列与MAdCAM的序列极其相似，导致α4β7CD4细胞更容易被HIV 感染。归巢至肠道的被感染的α4β7 CD4细胞能够向肠道输送HIV，加重肠道感染，成为HIV致病机制之一，有效阻止或降低HIV 感染α4β7 CD4细胞，可能会对HIV致病及维持肠道免疫功能有重要作用。据不完全统计，目前在研的α4β7药物约40余种，适应症主要以包括溃疡性结肠炎（UC）、克罗恩病（CD）在内的炎症性肠病（IBD）为主。本月，礼来宣布以约32亿美元收购Morphic，并获得靶向α4β7抑制剂MORF-057在内的权益；目前MORF-057正在开展两项治疗UC的II期临床、一项治疗CD的II期临床。目前，仅武田的维多珠单抗（vedolizumab）、艾伯维的ABBV-382，Population Council的Rh-α4β7开发用于HIV感染；其中在该适应症领域，最为活跃的即为艾伯维的ABBV-382，具有“同类最佳”的潜力。关于HIV HIV是一种逆转录病毒，在人体细胞内感染过程如下：(1)HIV与细胞粘附开始感染，(2)与细胞膜融合、脱衣壳进入细胞，(3)在细胞质中逆转录后进入细胞核并整合到宿主细胞染色体的DNA中，(4)转录、翻译、装配、出芽并成熟后形成新的子代病毒。 HIV主要侵犯人体免疫系统，主要表现为CD4+ T细胞数量不断减少，最终导致人体免疫细胞功能缺陷并引起各种感染和肿瘤发生，还会增加心血管疾病、骨病、肾病等疾病的发病风险。根据感染后的临床表现，HIV感染全过程可分三个期，(1)急性期，通常发生在感染HIV后的6个月内，临床表现以发热最为常见；(2)无症状期，一般持续4-8年，HIV在感染者体内不断复制，免疫系统受损；(3)艾滋病期，感染HIV后的终末阶段。根据联合国艾滋病规划署(UNAIDS)于2023年7月发布的数据：2022年全球有3,900万艾滋病感染者，2,980万人正接受抗逆转录病毒治疗；新增130万艾滋病感染者，63万人死于艾滋病相关疾病。根据中国疾病预防控制中心(CDC)数据：截止2022年底，我国现存HIV感染患者约122.3万例，新增10.7万例，新增艾滋病相关死亡3.0万例。从传播途径看，目前我国HIV感染者以性传播为主，占比达到97.6%，其中异性传播占72.0%，同性传播占25.6%。我国HIV患者新发和死亡数量针对HIV的抗病毒治疗是为了最大限度抑制病毒复制，重建免疫功能，降低HIV感染的发病率和病死率，从而延缓疾病进展、延长患者生命、提高生活质量。根据《中国艾滋病诊疗指南(2021年版)》，目前国际上抗逆转录病毒药物主要有六大类：核苷类反转录酶抑制剂(NRTIs)、非核苷类反转录酶抑制剂(NNRTIs)、蛋白酶抑制剂(PIs)、整合酶抑制剂(INSTIs)、融合抑制剂(FIs)、CCR5拮抗剂。鸡尾酒疗法(HAART)通过联合使用3种抗病毒药物治疗艾滋病，能够减少耐药、增强疗效以有效控制病情，是治疗艾滋病的标准治疗方案，并使得艾滋病成为一种慢性疾病。提高有效性、安全性以及克服耐药推动抗HIV药物迭代以及新机制药物出现，同类药物迭代解决上一代产品存在的问题，开发新机制药物为多重耐药患者带来新的希望。根据弗若斯特沙利文的资料显示，全球HIV 药物市场预计2025 年将达到479亿美元及2030 年将达到575 亿美元，2021 年至2025 年的复合年增长率为6.0%，而2025 年至2030 年的复合年增长率为3.7%。全球HIV药物市场（2017-2030E，十亿美元）关于艾伯维在HIV的布局除传统蛋白酶抑制剂(PI)利托那韦和洛匹那韦，及CCR5 拮抗剂cenicriviroc外，公司近年来在HIV领域重点开发的另一款药物是PD-1单抗budigalimab，目的是在不用ART的情况下，实现持久性HIV抑制，也就是艾滋缓解或功能性治愈。根据在欧洲艾滋病大会上(EACS 2023)披露的数据，budigalimab以每两周一次的频率，通过静脉注射方式给予参与者，每次注射剂量为10毫克，总共进行了四次注射。在完成治疗的9名参与者中，6名参与者出现了病毒反弹延迟，和/或无ART的病毒抑制，其中2人被认为是治疗后控制者。在这2人中，一人在ART中断后，病载无法检测状态维持了约50天，然后增加到约350个拷贝，随后下降并在19个月里持续抑制病毒在100个拷贝以下；另一人在治疗中断后约20天出现了病载高峰，达到约700拷贝，随后迅速下降，并在18个月里持续抑制病毒在200拷贝以下。艾伯维在HIV感染的布局参考资料 1、CDE官网 2、王蕊,计云霞,陆小凡.HIV感染急性期治疗对α4β7肠道归巢CD4细胞保护作用的研究[J].中国艾滋病性病,2024,30(01):1-7.DOI:10.13419/j.cnki.aids.2024.01.01. 3、广发证券、华创证券、华安证券 4、红枫湾Redmaplebay 感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

并购临床2期引进/卖出临床结果临床终止

100 项与布格利单抗相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
非鳞状非小细胞肺癌	临床3期	澳大利亚	AbbVie, Inc.	2024-04-10
非鳞状非小细胞肺癌	临床3期	以色列	AbbVie, Inc.	2024-04-10
非鳞状非小细胞肺癌	临床3期	中国台湾	AbbVie, Inc.	2024-04-10
非鳞状非小细胞肺癌	临床3期	美国	AbbVie, Inc.	2024-04-10
肝细胞癌	临床3期	意大利	AbbVie, Inc.	2024-01-11
肝细胞癌	临床3期	美国	AbbVie, Inc.	2024-01-11
肝细胞癌	临床3期	西班牙	AbbVie, Inc.	2024-01-11
肝细胞癌	临床3期	法国	AbbVie, Inc.	2024-01-11
肝细胞癌	临床3期	波多黎各	AbbVie, Inc.	2024-01-11
肝细胞癌	临床3期	中国台湾	AbbVie, Inc.	2024-01-11

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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


NCT04306900 (ESMO2024) 人工标引	临床2期	晚期胰腺腺癌一线 HLA-DQ	59	TTX-030/TTX-030+budigalimab	(餘築構鏇齋憲艱窪齋憲) = neutrophil count decreased (41%), neutropenia (22%), anaemia (20%), fatigue (12%) and ALT increased (10%). 糧鹽鏇鬱壓衊願夢夢鹽 (構鏇鹹鬱觸窪憲淵選觸 )	积极	2024-09-14
				TTX-030/TTX-030+budigalimab (HLA-DQ high)
NCT03821935 (AACR2024) 人工标引	临床1期	卵巢颗粒细胞瘤	57	Livmoniplimab + Budigalimab	(餘艱鹹範齋獵窪蓋夢襯) = 鏇遞築觸壓廠廠窪選膚鹹積鹽衊築鹹廠積遞構 (窪鹹醖範願簾齋鏇構衊 ) 更多	积极	2024-04-05
NCT03821935 (ASCO_GU2024) 人工标引	临床1期	尿路上皮癌	48	Livmoniplimab + budigalimab	(繭遞顧衊蓋觸積齋網窪) = 鬱窪鬱遞艱簾網壓壓膚衊艱鹽壓簾鹽選選獵餘 (網蓋觸願壓製淵膚製鹹, 12.9 ~ 39.5) 更多	积极	2024-01-25
NCT03000257 (Pubmed \| J Immunother)	临床1期	HR阳性/HER2低表达实体瘤	182	Budigalimab 250mg Q2W	(憲壓艱膚獵糧鏇範築艱) = 鹹廠觸鏇獵夢鑰鹹壓壓廠築網鏇積齋鬱艱鹽鹹 (廠壓顧醖憲糧觸廠壓網 )	积极	2022-01-17
				Budigalimab 500mg Q4W	(憲壓艱膚獵糧鏇範築艱) = 製壓衊憲網壓獵鹹觸選廠築網鏇積齋鬱艱鹽鹹 (廠壓顧醖憲糧觸廠壓網 )
NCT03000257 (Pubmed \| Cancer Immunol Immunother)	临床1期	头颈部鳞状细胞癌 \| 非小细胞肺癌	81	Budigalimab 250 mg	(製範襯鹽築蓋築窪繭鹹) = 艱顧鑰憲構膚繭襯窪選餘鹽範艱觸鑰鏇淵憲繭 (簾艱艱鏇觸醖窪齋選遞, 5.1 ~ 24.5)	-	2021-07-03
				Budigalimab 500 mg	(製範襯鹽築蓋築窪繭鹹) = 製觸鏇鹹製衊齋獵憲製餘鹽範艱觸鑰鏇淵憲繭 (簾艱艱鏇觸醖窪齋選遞, 9.2 ~ 32.6)
NCT03000257 (M15-892, Pubmed) 人工标引	临床1期	小细胞肺癌	31	rovalpituzumab tesirine+budigalimab	(窪觸積選構膚糧艱簾壓) = 窪願憲憲窪獵鑰網獵餘鑰襯蓋夢醖觸襯構顧構 (簾廠衊構衊衊齋遞顧鹽 ) 更多	积极	2021-01-01
NCT03000257 (AACR2020)	临床1期	HR阳性/HER2低表达实体瘤	81	Budigalimab IV 250 mg every two weeks	(鬱構夢夢製製範壓艱願) = 鑰醖鏇齋簾範衊製範壓憲鹽糧艱選淵醖糧觸憲 (遞範膚襯範積襯範鑰壓 )	-	2020-08-15
				Budigalimab IV 500 mg every four weeks	(鬱構夢夢製製範壓艱願) = 鬱廠構餘餘醖構壓構廠憲鹽糧艱選淵醖糧觸憲 (遞範膚襯範積襯範鑰壓 )