An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Budigalimab in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) inhibitor (budigalimab) to adult participants to treat NSCLC.
ABBV-400 and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of ABBV-400 in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 4 treatment groups. Two groups will receive budigalimab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed. One group will receive the standard of care (SOC) pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 172 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with budigalimab or receive IV budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed, or IV SOC pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.
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2025-02-20

申办/合作机构

AbbVie, Inc.

NCT06632951

/ Recruiting临床2期

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2025-01-20

申办/合作机构

AbbVie, Inc.

NCT06628310

/ 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2024-12-13

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 : official journal of the European Society for Medical Oncology

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

Article

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

BACKGROUND:

The 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 METHODS:

The 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.

RESULTS:

In 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.

CONCLUSIONS:

We 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 immunotherapy (Hagerstown, Md. : 1997)4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: Tribouley, Catherine ; McLaughlin, Robert Tyler ; Masica, David L. ; Sheridan, James ; Vosganian, Greg ; Englert, Stefan ; Turan, Tolga ; Guo, Claire ; Afar, Daniel ; Zhang, Chun ; Lambert, Stacie L. ; Fang, Yuni

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, immunotherapy : CII2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: Warburton, Lydia ; Englert, Stefan ; Gazzah, Anas ; Shiah, Her-Shyong ; Lin, Chia-Chi ; Parikh, Apurvasena ; Afar, Daniel E ; Cassier, Philippe A ; Moreno, Victor ; Gao, Bo ; Vosganian, Gregory ; Cervantes, Andrés ; Calvo, Emiliano ; Alanko, Tuomo ; Tanner, Minna ; Italiano, Antoine ; Lambert, Stacie ; Peltola, Katriina J ; Roda, Desamparados ; Tosi, Diego ; Millward, Michael

Abstract:

Background:

Budigalimab 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 methods:

Patients 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.

Results:

In 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.

Conclusions:

The 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）

2025-02-19

·医药观澜

一年只需两针，HIV疗法获新突破！超10款新药正在中国开展临床研究

▎药明康德内容团队报道今日，吉利德科学（Gilead Sciences）宣布，美国FDA已接受其长效HIV预防药物lenacapavir（来那帕韦）的新药申请，用于HIV感染的暴露前预防（PrEP）。这款新药已于今年1月在中国获批首个适应症，用于治疗多重耐药型HIV感染成人患者。其一年仅需注射两次，有望为HIV预防带来重要突破。这一消息再次将公众视野聚焦于HIV治疗领域。近年来，HIV治疗领域不断取得突破，从每日服药到长效注射，从单一疗法到联合用药，患者拥有了更多治疗选择。与此同时，更多在研HIV新药管线还在继续推进，致力于为患者带来更多高效、安全、便利的治疗选择。本文盘点10多款正在中国进行临床开发的HIV研发管线（包括联合疗法，不完全统计），这些在研产品涵盖核苷类逆转录酶抑制剂、非核苷类逆转录酶抑制剂、整合酶抑制剂、IL-7融合蛋白、IL-21融合蛋白、α4β7整合素单克隆抗体、抗PD-L1联合疗法、治疗性核酸疫苗等各类机制药物。图片来源：123RF 歌礼：ASC22联合西达本胺作用机制：抗PD-L1抗体联合HDAC抑制剂根据歌礼公开资料，该公司正在推进ASC22联合西达本胺用于人类免疫缺陷病毒（HIV）感染功能性治愈的2期临床研究。ASC22（恩沃利单抗）是一款可皮下注射的抗PD-L1单域抗体，通过阻断PD-1/PD-L1信号通路发挥治疗作用，具有重建慢性病毒感染患者病毒特异性免疫应答的潜力。歌礼已经从苏州康宁杰瑞获得ASC22全球独家开发和商业化权益，用于治疗包括乙型肝炎和艾滋病在内的所有病毒性疾病。西达本胺是微芯生物开发的一款亚型选择性组蛋白去乙酰化酶（HDAC）抑制剂，已在中国获批用于治疗外周T细胞淋巴瘤、乳腺癌等适应症。此前于2023年7月公布的2期临床研究结果显示，ASC22联合西达本胺疗法具有良好的耐受性，且有效地激活了潜伏的HIV病毒库。前沿生物：FB1002（3BNC117联合艾博韦泰）作用机制：抗HIV的广谱中和抗体+HIV长效融合抑制剂 FB1002是前沿生物正在开发一种抗HIV病毒药物，这是将艾博韦泰（艾可宁，已在中国获批上市）与3BNC117组成的联合疗法，为长效、注射、双靶点融合抑制剂，拟每2~4周给药一次。根据前沿生物公开资料介绍，该组合疗法拟探索“多重耐药、维持疗法、免疫治疗和预防”多种适应症。在多重耐药适应症方面，艾博韦泰联合3BNC117抗体作用靶点分别为HIV膜蛋白GP41和GP120，都可阻止HIV病毒进入CD4+T细胞，也可以阻断细胞介导的感染。两药组合可提供更广泛的病毒株覆盖，产生更高数量级和持续时间更长的抗逆转录病毒效果。在免疫疗法适应症上，通过激活免疫系统清除被HIV病毒感染的细胞（即病毒库），提高针对HIV病毒的自身免疫反应，使患者在一定期间内不使用任何药物而病毒复制得到有效控制，探索功能性治愈。目前，该组合疗法正处于2期临床研究阶段。艾迪药业：ACC017片作用机制：HIV整合酶抑制剂 ACC017片是艾迪药业在研的化学1类新药，为全新结构的整合酶链转移抑制剂。通过抑制HIV整合酶活性，可有效阻断HIV基因组整合进入宿主基因组DNA，临床拟用于治疗HIV感染。临床前研究显示ACC017抗病毒效果良好、与其它多种抗逆转录病毒药物具有协同作用、安全窗大等特点。该产品药物口服吸收暴露水平良好，可支持每日给药一次。目前，ACC017片已进入1b/2a期临床研究阶段。康宝生物、中国医学科学院病原生物学研究所：利普韦肽、LP-98 作用机制：HIV膜融合抑制剂利普韦肽是一款多肽类HIV膜融合抑制剂。该产品是在对HIV融合蛋白结构与功能深入研究的基础上，通过理性设计而获得的强效膜融合抑制剂，研究表明，其对各种亚型HIV的抑制活性提高数千倍之多，而且对T20耐药病毒株也高度有效；在恒河猴SHIV感染模型，利普韦肽单独给药可以迅速将病毒载量降到检测线以下水平，表现出长效的治疗效果。根据中国药物临床试验登记与信息公示平台，康宝生物与中国医学科学院病原生物学研究所正在开展一项2期临床研究，评价注射用利普韦肽联合核苷药物在未接受过抗病毒治疗的HIV感染者中的有效性、安全性。此外，康宝生物与中国医学科学院病原生物学研究所还正在开发LP-98，这是在对利普韦肽结构与功能深入研究的基础上进一步优化的膜融合抑制剂，通过恒河猴模型研究发现，其低剂量单药治疗能够有效抑制SHIV（一种HIV和SIV嵌合病毒）病毒复制，且维持长期有效的治疗效果。该产品正处于1/2期临床阶段，研究旨在评估在未接受过抗病毒治疗的HIV感染者中多次皮下注射LP-98后的安全性和耐受性。杰科生物：JL18008注射液作用机制：长效IL-7融合蛋白 JL18008注射液为杰科生物及美国Jecho Labs研发的长效IL-7细胞因子融合蛋白，其通过受体结合，激活JAK/STAT、PI3K/AKT信号通路，提高HIV免疫重建不良患者的CD4+T淋巴细胞计数水平，进而重建免疫功能。该分子通过巧妙的序列设计，解决了传统细胞因子类药物在体内半衰期较短的痛点。该产品目前正在中国开展1/2期临床研究，并已经在美国获批临床，针对HIV免疫重建不良患者。绝大多数HIV/AIDS患者经抗逆转录病毒治疗后可实现免疫功能重建，即CD4+ T淋巴细胞数量和免疫功能恢复至正常或接近正常水平，但仍有部分HIV/AIDS患者即使能够长期维持病毒抑制，仍不能实现免疫重建，这些患者被称为免疫重建不良者或免疫无应答者（INRs）。艾伯维：ABBV-382 作用机制：α4β7整合素单克隆抗体 α4β7整合素在HIV-1感染的发病机制中起重要作用。ABBV-382是一种α4β7整合素单克隆抗体，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。在中国，ABBV-382正在开展1期临床，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。在全球范围内，艾伯维还在开发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。真实生物：CL-197 作用机制：嘌呤核苷抗病毒药物 CL-197是一款在研新型口服HIV候选药物，为新一代口服长效嘌呤核苷抗病毒药物。该产品通过口服给药，其半衰期超过168小时，有望每周仅需服药一次。这种相对方便的服药方案亦可能提高服药依从性，从而改善临床结果。根据真实生物最新的招股书显示，该公司已经针对CL-197开展了1期临床研究，预计2025年完成。此外，真实生物还基于阿兹夫定与CL-197在治疗HIV感染方面的潜在联合长效作用，开发了全口服长效复方片剂（阿兹夫定/CL-197），目前正处于临床前研究阶段。阿兹夫定是一款同时针对逆转录酶和病毒感染因子的双靶点治疗HIV感染核苷类口服药物，真实生物认为，阿兹夫定/CL-197通过对三靶点的联合作用，作为一种鸡尾酒疗法，可有效降低耐药性出现。医克生物：ICVAX 作用机制：艾滋病治疗性核酸疫苗 ICVAX为医克生物在研的艾滋病治疗性核酸疫苗，该产品旨在诱导具有广谱、多功能病毒特异性T细胞，实现无须抗逆转录病毒疗法（ART）而控制病毒复制的目标。2024年11月，医克生物公布了ICVAX的1期临床研究积极结果。研究显示，接受ICVAX疫苗的受试者皆诱导出预期的T细胞免疫应答。在接受最佳ICVAX剂量的受试者中，大多数人的T细胞反应增加了2倍以上。值得关注的是，受试者体内的一种独特的T细胞亚群在接种ICVAX后有所增长，而这种T细胞亚群是在“精英控制者”（elite controllers）内能够抑制艾滋病病毒的功能性T细胞。目前，医克生物正准备与NMPA沟通多中心、双盲、安慰剂对照、剂量探索的2期临床试验方案，进一步探索 ICVAX 的免疫原型性和控制病毒载量的有效性。乘典生物：CD-001 作用机制：IL-21融合蛋白药物 CD-001是乘典生物针对目前临床PD-1抑制剂肿瘤治疗有效率不高的问题，自主研发的一种靶向肿瘤反应性CD8+T细胞的IL-21融合蛋白药物，在阻断PD-1免疫抑制信号的同时，体内选择性扩增肿瘤反应性CD8+T细胞，可显著提高免疫治疗的疗效。该产品拟开发的适应症包括肿瘤和HIV感染，其中针对实体瘤适应症已经在中国和美国获批IND，针对HIV适应症预计于2025年上半年在中国和美国申报IND。恒瑞医药：HRS5685 作用机制：化药1类新药根据恒瑞医药此前公告，HRS5685能够抑制HIV-1复制，临床拟用于HIV-1感染者的治疗。根据中国药物临床试验登记与信息公示平台，恒瑞医药子公司瑞可迪生物正在针对HRS5685片开展针对健康受试者的安全性、耐受性和药代动力学1期研究。中国科学院上海药物研究所、中国科学院昆明动物研究所：塞拉维诺片作用机制：CCR5拮抗剂几乎所有HIV-1病毒感染初期均以CCR5受体作为共受体，CCR5受体在HIV-1感染过程中发挥重要作用，因此成为抗HIV-1的重要靶点。塞拉维诺片是通过计算机辅助药物设计，采用基于结构和改变代谢统计的药物设计策略开发出新结构类型CCR5拮抗剂。该产品对CCR5受体具有更好的拮抗活性，对多种HIV病毒株、临床株及耐药株的抑制活性和治疗指数相当或更佳。该产品正处于针对HIV感染的1期临床研究阶段。以上仅盘点部分在中国研发的HIV临床管线，目前还有其他多款针对HIV的在研产品正在进行前期研发，比如多款处于研究者发起的临床研究（IIT）阶段的CAR-T细胞药物、iNKT细胞药物等等。此外多款已经获批上市的HIV药物也正在探索更多的适应症。作为创新的赋能者、客户信赖的合作伙伴以及全球健康产业的贡献者，药明康德致力于通过其独有的CRDMO模式，以及其业内领先的感染性疾病新药研发赋能平台，助力全球共同应对这一重大的健康威胁。早在2019年，HIV“鸡尾酒”疗法开发先驱何大一教授就曾做客药明康德健康产业论坛，分享抗HIV药物开发的洞见。在2024年世界艾滋病日前后，药明康德内容团队也发表了盘点文章，系统回顾HIV标准疗法的现状，同时梳理在研新药亮点。期待在行业内外人士的共同合作和努力下，一个没有艾滋病的未来能够早日成为现实。参考资料： [1]中国药物临床试验登记与信息公示平台官网. [2]各公司官网及公开资料本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床2期疫苗免疫疗法临床1期ASCO会议

2025-01-15

·SYNAPSE

2025年1月15日全球新药进展早知道

1. 智翔金泰狂犬病病毒双特异抗体申报上市 1月14日，CDE官网显示，智翔金泰瑞的斯乐韦米单抗注射液（GR1801）上市申请已获受理，用于成人疑似狂犬病病毒暴露后的被动免疫。斯乐韦米单抗是全球首个用于狂犬病被动免疫的双特异性抗体，由智翔金泰自主研发，作用靶点为RABV的包膜糖蛋白（Glycoprotein，G蛋白）。该药为scFv+Fab结构的双特异性抗体，使用KIH技术解决重链错配问题，使用scFv融合技术解决轻链错配问题，通过靶向结合G蛋白表位I和/或III，阻断其与受体的结合，在狂犬疫苗主动免疫完全发挥保护作用前阻滞病毒对神经的侵染，预防狂犬病。截至目前，国内仅有2款抗狂犬病病毒抗体药物获批上市。 2. 乐普生物溶瘤病毒拟纳入突破性治疗 1 月 14 日，CDE 官网显示，乐普生物递交的 CG0070 注射液拟纳入突破性治疗，适应症为对卡介苗（BCG）无应答的高危非肌层浸润性膀胱癌（NMIBC）伴原位癌（CIS）患者。CG0070（Cretostimogene Grenadenorepvec）是 CG Oncology 公司开发的一款具有双重作用机制的溶瘤病毒免疫疗法，靶向 Rb-E2F 通路，可选择性复制、裂解癌细胞并刺激免疫反应。乐普生物拥有 CG0070 在中国内地、香港、澳门地区的开发、制造和商业化权益。 3. 艾伯维c-MET ADC启动肺癌二线联合治疗临床 1月13日，艾伯维在clinical trials网站上，登记了下一代c-Met ADC药物Telisotuzumab Adizutecan 联合PD-1抗体 Budigalimab 二线治疗转移性鳞状非小细胞肺癌的1/2期临床试验NCT06772623，该临床预计于2025年2月底启动，入组人数为172例。此前于2024年9月27日，艾伯维宣布已向FDA递交c-Met靶向ADC药物telisotuzumab vedotin（Teliso-V，ABBV-399）的生物制品许可申请（BLA），用于治疗既往接受过治疗的c-Met蛋白过表达、表皮生长因子受体（EGFR）野生型晚期/转移性非鳞状非小细胞肺癌（NSCLC）成人患者。 4. 再生元PD-1抑制剂辅助治疗高危皮肤鳞状细胞癌显著提升无病生存期 1月13日，再生元制药宣布了3期C-POST试验的积极结果。该试验表明，PD-1抑制剂Libtayo®（cemiplimab）辅助治疗，能显著提高高危皮肤鳞状细胞癌（CSCC）患者术后的无病生存期（DFS），这一成果为这类患者的治疗带来了新希望。在首次预设的中期分析中，与安慰剂相比，接受Libtayo®治疗的患者疾病复发或死亡风险降低了68%（风险比：0.32；95%置信区间：0.20 - 0.51；$p<0.0001$）。这使得Libtayo®成为首个在辅助治疗高危CSCC中，展现出具有统计学意义和临床意义疗效的免疫疗法，而近期Keytruda®在相同辅助治疗场景下的3期试验却未能成功。 5. 绿叶制药新一代抗精神病药物在美国获准开展临床试验 1月14日，绿叶制药集团宣布，其自主开发的新一代抗精神病药物LY03020已获得美国食品药品监督管理局（FDA）许可开展临床试验，拟用于治疗精神分裂症。LY03020基于绿叶制药新分子实体/新治疗实体技术平台开发，是全球首个痕量胺相关受体1（TAAR1）和5-羟色胺2C受体（5-HT2CR）双靶点激动剂。临床前研究已表明，LY03020可显著改善精神分裂症阳性、阴性症状和认知障碍，且未见明显的EPS和体重增加、糖脂代谢异常等代谢综合征风险。LY03020亦在中国进入临床阶段。 1. 礼来25亿美元收购Scorpion，获得小分子PI3Kα抑制剂 1月13日，礼来公司和开Scorpion Therapeutics宣布，礼来公司将收购Scorpion的小分子PI3Kα抑制剂项目STX-478。STX-478是一种每日一次的口服突变选择性PI3Kα抑制剂，目前正在乳腺癌症和其他晚期实体瘤的1/2期临床试验中进行评估。根据协议条款，礼来将收购Scorpion，Scorpion股东将获得高达25亿美元的现金，包括预付款和在达到某些监管和销售里程碑后的后续付款。此外，作为交易的一部分，Scorpion将剥离一个新实体，以拥有其员工和非PI3Kα管线资产。 2. 吉利德17亿美元合作开发STAT6小分子疗法 1月13日，吉利德与LEO Pharma日前宣布达成战略合作伙伴关系，共同加速LEO Pharma的小分子口服STAT6项目的开发和商业化，旨在为炎症性疾病患者提供潜在治疗方案。根据该合作协议，吉利德将收购LEO Pharma的全部口服STAT6小分子抑制剂和靶向蛋白降解剂项目。吉利德将拥有开发、生产和商业化小分子口服STAT6项目的全球权利。LEO Pharma将有权选择在美国以外地区的皮肤病领域共同商业化口服项目。LEO Pharma将有资格获得总计高达17亿美元的款项，其中包括2.5亿美元的预付款。内容来源于网络，如有侵权，请联系删除。

小分子药物并购突破性疗法申请上市临床研究

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

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


NCT03821935 (NCT03821935, Pubmed \| Front Oncol)	临床1期	晚期恶性实体瘤 GARP:TGF-ß1 complex	-	Livmoniplimab	顧繭齋製壓鹹壓鑰蓋蓋(蓋艱襯衊醖壓蓋製鹽鏇) = 鏇淵積網壓鏇選鹹齋衊艱製願構壓範鏇餘窪餘 (鹽鏇憲鬱醖構膚顧膚鏇 )	积极	2024-10-29
				Budigalimab	蓋簾選鬱選憲觸壓衊齋(觸窪艱壓製獵簾遞膚窪) = 窪憲選構顧鹹糧蓋獵鏇遞淵膚積窪餘範夢膚願 (鑰網夢襯糧醖顧積餘淵 ) 更多
NCT03821935 (ASCO2024)	临床1期	实体瘤 \| 尿路上皮癌 TGF-β1 \| GARP:TGF-β1 complex	200	Livmoniplimab 1500 mg + Budigalimab 500 mg	獵繭齋築壓顧膚壓積範(鏇構願築製鏇觸獵範積) = 鬱構夢獵襯廠繭窪製廠範願選簾齋齋鑰蓋齋鏇 (鏇膚鬱遞醖壓構齋醖築, 12.9 ~ 39.5) 更多	积极	2024-05-24
NCT03821935 (ASCO_GU2024) 人工标引	临床1期	尿路上皮癌	48	Livmoniplimab + budigalimab	願餘襯膚醖膚築鹹蓋選(鹽憲壓醖簾獵繭艱齋艱) = 網糧簾醖襯範夢積鹹觸鏇襯艱鏇衊製顧壓簾艱 (餘窪鏇網蓋衊鬱積膚衊, 12.9 ~ 39.5) 更多	积极	2024-01-25
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	網鹹製糧廠顧選艱鏇獵(膚壓艱憲夢艱鹽壓鑰遞) = 夢餘製積選襯夢蓋築窪蓋簾顧鹹選鏇襯夢窪齋 (壓廠製願窪餘遞顧夢餘, 5.1 ~ 24.5)	-	2021-07-03
				Budigalimab 500 mg	網鹹製糧廠顧選艱鏇獵(膚壓艱憲夢艱鹽壓鑰遞) = 窪選構糧醖觸網衊廠壓蓋簾顧鹹選鏇襯夢窪齋 (壓廠製願窪餘遞顧夢餘, 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	窪襯憲壓夢鹽淵積廠鹹(鬱願憲鑰餘鏇鬱齋築鑰) = 夢蓋糧觸壓齋襯製網鏇獵糧觸壓廠衊願遞鑰獵 (糧鹽餘鏇醖繭衊齋膚繭 ) 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	齋鑰蓋淵網鏇遞範餘繭(艱夢齋糧觸網鏇衊餘範) = 築簾憲淵構夢製鏇餘夢夢鹽艱範獵衊淵膚選鹽 (醖襯鬱餘獵膚糧餘製餘 )	-	2020-08-15
				Budigalimab IV 500 mg every four weeks	齋鑰蓋淵網鏇遞範餘繭(艱夢齋糧觸網鏇衊餘範) = 艱蓋夢鬱顧選網遞餘膚夢鹽艱範獵衊淵膚選鹽 (醖襯鬱餘獵膚糧餘製餘 )
NCT03000257 (M15-891, SITC2018)	临床1期	晚期恶性实体瘤	62	ABBV-181 1 mg/kg	襯糧鹽鏇簾網鏇鹹繭夢(製齋憲膚鹹鑰襯衊膚淵) = 憲繭繭壓繭糧製淵積鹽範製鑰醖鏇鏇鬱構膚膚 (憲膚襯鹽觸蓋夢繭艱鹽, 31 ~ 59) 更多	积极	2018-11-06
				ABBV-181 3 mg/kg	襯糧鹽鏇簾網鏇鹹繭夢(製齋憲膚鹹鑰襯衊膚淵) = 壓網簾襯醖選廠衊鏇齋範製鑰醖鏇鏇鬱構膚膚 (憲膚襯鹽觸蓋夢繭艱鹽, 31 ~ 59) 更多