Among critically ill patients, many die, and many of the survivors and their family members struggle for years with reduced quality of life. Critically ill patients are treated in intensive care units (ICUs). Here, they receive life support, e.g., mechanical ventilation and advanced support of the circulation (heart and blood vessels) and kidneys. In addition, ICU patients receive many other treatments. It is, however, uncertain if all the treatments provide value for the patients. The desirable effects of many treatments are uncertain, and some may be wasteful or even harmful.
Clinical trials are necessary to validly assess the desirable and undesirable effects of different treatments. However, conventional clinical trials have limitations:
* They typically only assess a single question related to a single comparison of treatments at a time.
* They are often not very flexible, including with regards to the number of participants needed, and this increases the risk that a trial will end up as inconclusive.
* There is no or limited re-use or sharing of infrastructure across trials, leading to duplicate work and resource use.
* Trial participants do usually not benefit from the obtained knowledge before the trial concludes.
* Involvement of patients, family members, and other stakeholders is typically limited, which may decrease the relevance of the questions addressed.
With the Intensive Care Platform Trial (INCEPT), we aim to tackle these challenges by establishing a flexible platform trial that continuously learns from the obtained results. The platform trial may run forever with simultaneous and continuous assessment of many treatments. INCEPT will continuously learn from the accrued data and use these to improve the treatment of both participating and future patients. With INCEPT, we are also building a framework for thorough and extensive involvement of key stakeholders, including patients and family members. INCEPT will improve the way clinical trials are done and increase the probabilities that treatments are improved. This will:
* Directly improve outcomes for ICU patients.
* Relieve a strained healthcare system by discarding inefficient or harmful treatments.
* Ensure that new treatments are beneficial or cost-effective before implementation.
* Lower the costs and burdens of assessing more treatments in the critically ill.

开始日期2025-03-01

申办/合作机构

Rigshospitalet

[+18]

NCT06637618 / Not yet recruitingN/AIIT

Cluster and Registry Trial Of the Working Group of Heart Failure in Denmark. Does the Strategy of Initiation of Heart Failure Medication Matter in the Real World.

This study will tests whether a strategy of upfront prescription of mineralocorticoid receptor antagonists (MRA) is different from usual care, where MRA are usually prescribes as the last drug of the four drug classes used in the treatment of heart failure with reduced cardiac pump function (ace-inhibitor, beta blocker, sodium-glucose-2 inhibitors, MRA).
The study is a national study that intends to include all adult Danish patients diagnosed with heart failure and reduced pump function from early 2025 til early 2029.
Treatment strategy will be decided by randomisation, where each heart failure clinic is randomised to one of the two strategies (upfront MRA vs. usual care) for one year, followed by cross-over to the other treatment strategy for one year.
Patients will be followed according to usual care at their respective heart failure clinic. Study-specific followup will be conducted through the Danish registries for a minimum of two years.
The primary goal of the study is to evaluate whether one of the two treatment strategies leads to fewer hospitalisations for heart failure and/or death at one year after study entry.
Other goals of the study is to evaluate whether one of the two strategies leads to less kidney disease, improved quality of life and improved cost-effectiveness

开始日期2025-02-01

申办/合作机构

Århus Universitetshospital

[+10]

NCT06617754 / Not yet recruitingN/AIIT

InternatioNal SeVerE CRSwNP Registry (INVENT) 2024-2028

The objective of the study is to collect real-life data worldwide, which already have been collected in national databases, to merge the data and the knowledge with the focus of better care for the individual patients, more efficient use of the hospital cost of biologics and working for "personalized medicine".

开始日期2025-01-01

申办/合作机构

Rigshospitalet

100 项与 Rigshospitalet 相关的临床结果

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0 项与 Rigshospitalet 相关的专利（医药）

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项与 Rigshospitalet 相关的文献（医药）

2024-12-31·European Clinical Respiratory Journal

Added value of EUS-B-FNA to bronchoscopy and EBUS-TBNA in diagnosing and staging of lung cancer

Review

作者: Christiansen, Ida S ; Crombag, Laurence ; Vilmann, Peter ; Clementsen, Paul F ; Laursen, Christian B ; Bodtger, Uffe ; Issa, Mohammad A

Background:

Bronchoscopy and EBUS are standard procedures in lung cancer work-up but have low diagnostic yield in lesions outside the central airways and hilar/mediastinal lymph nodes. Growing evidence on introducing the EBUS endoscope into the oesophagus (EUS-B) in the same session as bronchoscopy/EBUS gives access to new anatomical areas that can be safely biopsied.

Objective:

To summarize the current evidence of the added value of EUS-B-FNA to bronchoscopy and EBUS-TBNA in lung cancer work-up.

Methods:

A narrative review.

Results:

Few randomized trials or prospective studies are available. Prospective studies show that add-on EUS-B-FNA increases diagnostic yield when sampling abnormal mediastinal lymph nodes, para-oesophageal lung and left adrenal gland. A large retrospective series on EUS-B-FNA from retroperitoneal lymph nodes suggests high diagnostic yield without safety concerns, as do casuistic reports on EUS-B-FNA from mediastinal pleural thickening, pancreatic lesions, ascites fluid and pericardial effusions. No study has systematically assessed both diagnostic yield, safety, patient reported outcomes, adverse events and costs.

Conclusion:

The diagnostic value of add-on EUS-B to standard bronchoscopy and EBUS in lung cancer work-up appears very promising without safety concerns, giving the pulmonologist access to a variety of sites out of reach with other minimally invasive techniques. Little is known on patient-reported outcomes and costs. Future and prospective research should focus on effectiveness aspects to clarify whether overall benefits of add-on EUS-B sufficiently exceed overall downsides.

2024-12-31·BLOOD PRESSURE

Cardiovascular events according to blood pressure thresholds recommended by ACC/AHA

Article

作者: Eske Bruun, Niels ; Thanh Pham, Vi ; Søgaard, Peter ; Torp-Pedersen, Christian ; Boje Jensen, Gorm ; Nielsen, Gitte ; Louis Marott, Jacob ; Joseph, Gowsini ; Prescott, Eva ; Biering-Sørensen, Tor ; Møgelvang, Rasmus ; Kragh Andersen, Per

AIM:

The latest guidelines from ACC/AHA define hypertension at systolic blood pressure (SBP) 130-139 mmHg or diastolic blood pressure (DBP) 80-89 mmHg in contrast to guidelines from ESC/ESH defining hypertension at SBP ≥ 140 mmHg or DBP ≥ 90 mmHg. The aim was to determine whether the ACC/AHA definition of hypertension identifies persons at elevated risk for future cardiovascular outcome.

METHODS:

In a Danish prospective cardiovascular study, 19,721 white men and women aged 20-98 years were examined up to five occasions between 1976 and 2015. The population was followed until December 2018. The ACC/AHA definition of the BP levels were applied: Normal: SBP <120 mmHg and DBP <80 mmHg, Elevated: SBP 120-129 mmHg and DBP <80 mmHg, Stage 1: SBP 130-139 mmHg or DBP 80-89 mmHg, Stage 2: SBP ≥140 mmHg or DBP ≥90 mmHg. Absolute 10-year risk was calculated taking repeated examinations, covariates, and competing risk into account.

RESULTS:

For all outcomes, the 10-year risk in stage 1 hypertension did not differ significantly from risk in subjects with normal BP: The 10-year risk of cardiovascular events in stage 1 hypertension was 14.1% [95% CI 13.2;15.0] and did not differ significantly from the risk in normal BP at 12.8% [95% CI 11.1;14.5] (p = 0.19). The risk was highest in stage 2 hypertension 19.4% [95% CI 18.9;20.0] and differed significantly from normal BP, elevated BP, and stage 1 hypertension (p < 0.001). The 10-year risk of cardiovascular death was 6.6% [95% CI 5.9;7.4] in stage 1 hypertension and did not differ significantly from the risk in normal BP at 5.7% [95% CI 4.1;7.3] (p = 0.33).

CONCLUSIONS:

Stage 1 hypertension as defined by the ACC/AHA guidelines has the same risk for future cardiovascular events as normal BP. In contrast, the definition of hypertension as suggested by ESC/ESH identifies patients with elevated risk of cardiovascular events.

2024-12-31·European Clinical Respiratory Journal

Ultrasound in predicting improvement in dyspnoea after therapeutic thoracentesis in patients with recurrent unilateral pleural effusion

Article

作者: Frost Clementsen, Paul ; Fjaellegaard, Katrine ; Koefod Petersen, Jesper ; Laursen, Christian B ; Bhatnagar, Rahul ; Skaarup, Søren ; Alstrup, Gitte ; Bodtger, Uffe

Background:

In patients with recurrent pleural effusion, therapeutic thoracentesis is one way of relief. Correct prediction of which patients will experience relief following drainage may support the management of these patients. This study aimed to assess the association between ultrasound (US) characteristics and a relevant improvement in dyspnoea immediately following drainage.

Methods:

In a prospective, observational study, patients with recurrent unilateral pleural effusion underwent US evaluation of effusion characteristics and diaphragm movement measured by M-mode and the Area method before and right after drainage. The level of dyspnoea was assessed using the modified Borg scale (MBS). A minimal important improvement in dyspnoea was defined as delta MBS ≥ 1.

Results:

In the 104 patients included, 53% had a minimal important improvement in dyspnoea following thoracentesis. We found no association between US-characteristics, including diaphragm shape or movement (M-mode or the Area method), and a decrease in dyspnoea following drainage. Baseline MBS score ≥ 4 and a fully drained effusion were significant correlated with a minimal important improvement in dyspnoea (OR 3.86 (1.42-10.50), p = 0.01 and 2.86 (1.03-7.93), p = 0.04, respectively).

Conclusions:

In our study population, US-characteristics including assessment of diaphragm movement or shape was not associated with a minimal important improvement in dyspnoea immediately following thoracentesis.

项与 Rigshospitalet 相关的新闻（医药）

2024-10-06

·药事纵横

14家值得关注的ADC领域企业

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。抗体-药物偶联物(ADC)领域见证了偶联技术、连接子化学和使用的有效载荷的多样化，超越了传统的微管蛋白抑制剂，包括新的作用机制。随着大量融资和收购，对ADC研究的投资继续增长。此外，市场的地域扩张，特别是在中国，反映了全球对创新癌症疗法的推动，这从旨在将新型ADC带到临床的多次合作和许可协议中可以看出。以下是ADC领域的一些主要生物技术公司介绍。艾伯维/ImmunoGen 艾伯维以101亿美元收购ImmunoGen的战略举措加强了公司在ADC癌症领域，特别是实体肿瘤领域的影响力。此次收购包括ImmunoGen用于铂类耐药卵巢癌的旗舰癌症疗法ELAHERE (mirvetuximab soravtansine-gynx)，表明艾伯维雄心勃勃，希望通过各种实体瘤和血液系统恶性肿瘤的潜在变革项目，扩大其肿瘤学产品线。ImmunoGen的产品组合，包括下一代adc，如用于卵巢癌的IMGN-151和用于罕见血癌的pivekimab sunirine，增强了艾伯维在肿瘤学领域的研究能力和产品供应。此次收购不仅加速了艾伯维进入ADC市场的步伐，也是其在实体肿瘤治疗领域取得重大进展战略的关键一步。ELAHERE是首个在铂类耐药卵巢癌中显示出总生存获益的药物，其成功为艾伯维提供了一个在ADC领域领先的独特机会，并进一步开发创新的癌症治疗方法。除了收购ImmunoGen，艾伯维的ADC管线还包括早期开发项目，如ABBV-400，一种用于实体瘤的c-Met(间充质上皮转化因子)ADC，以及两种抗sez6(癫痫相关的6同源)ADC, ABBV-011和ABBV-706，旨在解决各种癌症适应症。 Adcendo Adcendo成立于2017年，是哥本哈根大学和Rigshospitalet的分拆公司。这家位于哥本哈根的生物技术公司利用其科学创始人发现的新靶点uPARAP受体，开发旨在改善癌症治疗结果的ADC。 uPARAP受体，也被称为Endo180，在人体细胞外基质的管理中起着关键作用，特别是在胶原重塑中。它对组织修复和维持至关重要，但在癌症进展中也起着重要作用，因为它在几种癌症类型中过度表达。 Adcendo已与澳大利亚免疫肿瘤公司GlyTherix合作，推进靶向GPC-1(一种与多种实体瘤类型相关的蛋白)的ADC的开发。此次合作旨在利用GlyTherix的Miltuximab(一种领先的抗GPC -1单克隆抗体)，进一步推进Adcendo将创新治疗方案推向市场的使命。最近，Adcendo与Duality Biologics达成了一项期权许可协议。该协议是Adcendo进一步发展其ADC产品线战略的一部分，该产品线专注于为各种类型的癌症创建疗法。此次合作旨在利用Duality Biologics的能力，潜在地增强Adcendo现有的ADC技术。这一合作关系反映了Adcendo正在努力探索ADC开发的新途径，旨在扩大其癌症治疗的范围和有效性。 Adcendo在2021年获得了5500万美元(5100万欧元)的A轮融资，并在2023年获得了3300万美元(3100万欧元)的额外融资，Adcendo处于有利地位，可以继续其在ADC领域的开创性工作。 AdcentrX Therapeutics AdcentrX正在建立一个创新ADC的内部管线，以解决当前该领域的限制和挑战。Adcentrx最近在A +轮融资中获得了3800万美元，后来又追加了1300万美元。此次融资继2021年的5000万美元A轮融资之后，标志着其ADC肿瘤学产品线的临床开发迈出了重要一步。 Adcentrx的主要候选产品ADRX-0706是一种针对Nectin-4的ADC, Nectin-4是一种在多种人类癌症中过度表达的细胞表面粘附蛋白。这种靶向策略是Adcentrx利用更稳定的连接器技术和利用“旁观者效应”更精确地向肿瘤输送有效载荷的方法的一部分，从而提高疗效，同时最大限度地减少副作用。该公司计划每年至少推进一个其他管线项目进入临床测试，这表明该项目正在开发中。ADRX-0706于2023年7月获得FDA新药研究申请批准。除了ADRX-0706, Adcentrx正在研究肿瘤学适应证的第二种候选药物，以及另一种旨在治疗免疫学疾病的候选药物。该公司还于2022年2月与AvantGen达成了为期三年的合作伙伴关系，共同开发用于新型ADC的抗体，以扩大其产品线，并解决癌症和其他严重疾病患者的需求。 Alentis Therapeutics Alentis Therapeutics是一家临床阶段的生物技术公司，专门开发ADC治疗Claudin-1阳性的器官纤维化和癌症。该公司的研发管线专注于抗claudin -1抗体作为治疗CLDN1阳性肿瘤和器官纤维化的一种新型治疗方法。Alentis正在通过临床开发推进两种领先的单克隆抗体，并且也在研究下一代抗CLDN1疗法，包括ADC、双特异性抗体和T细胞衔接器。 Alentis因其创新工作而备受关注，其在2023年4月完成了1.05亿美元的C轮融资。这笔资金用于支持其主要研究产品ALE的2期和1期项目F02和ALE，分别开发了C04及其CLDN1平台。 Alentis在其ALE的首次人体1期临床研究中报告了多次递增剂量(MAD)部分的阳性背线结果。F02证实该药物具有良好的安全性、暴露性和靶向生物活性。此外，该公司已经启动了第一例ALE患者的2期试验。F02用于ANCA相关性血管炎伴急进性肾小球肾炎(RPGN)。本试验具有重要意义，因为它研究了该药物的安全性、耐受性，以及在已知导致快速肾衰竭的情况下，保留肾功能的可能性。Lixudebart靶向Claudin-1 (CLDN1)有可能阻止和逆转纤维化，标志着治疗严重肾脏疾病的新方法。 Araris Biotech Araris Biotech AG 在 ADC 领域取得了显著进展，最近来自 Samsung Ventures 的投资就是其中的亮点。这笔资金支持 Araris 的 ADC 管线的发展，该管线专注于癌症治疗，采用创新的连接技术，旨在简化开发和提高药物疗效。该公司还成功筹集了 2400 万美元，以推进其 ADC 连接子技术，并将其 ADC候选药物（例如前景广阔的抗 CD79b）推向临床阶段。抗CD79b ADC 在临床前研究中显示出积极结果，显示出优于现有疗法的潜在优势。在 2023 年 AACR 年会上，Araris 展示了使用其专有连接子技术创建的两种 ADC 的临床前数据。这些靶向抗 Nectin-4 和抗 HER2 的 ADC 与已批准的 ADC 相比，显示出优异的抗肿瘤活性和稳定性，这表明 Araris 的技术具有开发更有效、更安全、药物载量更低的 ADC 的潜力。阿斯利康/第一三共阿斯利康和第一三共在 ADC 领域开展了重要合作，专注于 DS-1062 的开发和商业化，DS-1062 是一种靶向 TROP2（滋养层细胞表面抗原 2）的 ADC。这项合作凸显了 DS-1062 利用第一三共专有的 DXd ADC 技术治疗多种肿瘤类型的潜力，包括非小细胞肺癌（NSCLC）和三阴性乳腺癌（TNBC）。该合作伙伴关系使阿斯利康和第一三共能够分摊开发、商业化成本和利润，但日本除外，第一三共保留日本的独家权利。此外，肺癌研究基金会（LCRF）宣布与第一三共和阿斯利康开展一项新的研究合作，旨在资助多达三项专注于 ADC 的研究资助，以改善肺癌患者的预后。该计划旨在探索 ADC 在肺癌治疗中的潜力，特别关注 HER2 导向和 TROP2 导向的 ADC，包括 DS-1062，以研究其作用机制、生物标志物和耐药机制。此次战略合作是在他们在 HER2 定向 DXd ADC Enhertu 上的初步合作之后建立的。Enhertu 于 2022 年获得 FDA 批准，用于治疗携带特异性 HER2 突变的非小细胞肺癌（NSCLC）成人患者。该批准基于 DESTINY-Lung02 研究的结果，该研究表明 Enhertu 显着缩小了大多数患者的肿瘤，为特定肺癌患者提供了新的治疗选择。第一三共的 ADC 产品线广泛，包括针对不同抗原和癌症的各种候选药物。最前沿的是治疗 EGFR 突变（表皮生长因子受体）NSCLC 的 patritumab deruxtecan （HER3-DXd）和用于治疗 NSCLC 的 datopotamab deruxtecan （Dato-DXd）。第一三共在 ESMO Asia 和 SABCS 等重要会议上展示了其 DXd ADC 产品组合的数据，展示了其肿瘤学产品组合的深度。这包括对 NSCLC 中具有可操作基因组改变的 datopotamab deruxtecan 和 HER2 突变 NSCLC 中的 ENHERTU 的研究，展示了第一三共正在进行的研究，以通过 ADC 推进癌症治疗。两家公司都是 ADC 领域的关键参与者，阿斯利康利用合作来增强其肿瘤学产品线，而第一三共则专注于其专有的 DXd 技术，以开发有可能在癌症治疗中产生重大影响的 ADC。 BioNTech/DualityBio BioNTech 与 Duality Biologics 合作，一直专注于开发针对癌症和自身免疫性疾病的 ADC 疗法。他们著名的 ADC 候选药物 BNT323/DB-1303 目前正在进行针对转移性乳腺癌患者的关键 3 期试验。该试验是基于早期 1/2 期研究的积极安全性和有效性数据启动的，这些数据表明具有有希望的抗肿瘤活性，尤其是在既往接受过大量治疗的 HER2 低乳腺癌患者中。观察到的客观缓解率和疾病控制率令人鼓舞，突出了 BNT323/DB-1303 改善晚期实体瘤患者预后的潜力。此外，BNT323/DB-1303 已获得FDA的突破性疗法认定，用于治疗晚期子宫内膜癌。此次合作有望加快这些创新疗法向全球患者提供，BioNTech 拥有除中国大陆、香港和澳门以外的全球商业权利，而 DualityBio 保留这些地区的权利。百时美施贵宝百时美施贵宝（BMS）通过旨在增强其肿瘤产品组合的战略合作，显著加强了其在 ADC 市场的地位。其中一个值得注意的合作伙伴关系是与 SystImmune，涉及 EGFRxHER3 双特异性ADC BL-B01D1 的联合开发和商业化，交易价值 84 亿美元。在另一项战略举措中，BMS 与 Tubulis 达成了一项价值 10 亿美元的协议，利用 Tubulis 专有的 P5 偶联平台、一种用于半胱氨酸选择性偶联的新型化学试剂和“Tubutecan”有效载荷来开发针对实体瘤的 ADC。此次合作不仅涉及向 Tubulis 支付 2275 万美元的预付款，还包括潜在的开发、监管和商业里程碑付款，以及上市产品的特许权使用费。该联盟旨在为每个抗体靶点生成唯一匹配的 ADC，BMS 全权负责其后续开发、制造和商业化。 BMS 还以 1 亿美元的价格从 Orum Therapeutics 收购了一种 1 期血癌药物，从而扩大了其在 ADC 领域的影响力。有问题的药物 ORM-6151 是一种一流的抗 CD33（唾液酸结合 Ig 样凝集素 3）抗体驱动的 GSPT1 降解剂，针对急性髓性白血病（AML）和高危骨髓增生异常综合征，如果该计划成功，有可能获得 8000 万美元的里程碑付款。这些合作代表了公司扩大其 ADC 产品线的方法，利用创新技术开发癌症治疗疗法。葛兰素史克葛兰素史克（GSK）还通过战略收购和合作伙伴关系积极扩展其肿瘤产品组合，尤其是在 ADC 领域。最近一个值得注意的进展是 GSK 向 Hansoh Pharma 支付了 1.85 亿美元的预付款，以获得 HS-20093 的权利，HS-20093 是一种靶向 B7-H3 的 ADC，B7-H3 是一种在包括肺癌在内的许多不同癌症中表达的蛋白质。ADC 已在实体瘤（尤其是小细胞肺癌和肉瘤）中显示出临床活性的早期迹象，并将于 2024 年在中国以外的地区开始 1 期临床试验。此外，该公司还达成了另一笔涉及靶向 B7-H4 的 ADC 的重大交易，称为 HS-20089，这表明 GSK 对靶向各种癌症（包括卵巢癌和子宫内膜癌）中丰富蛋白质的 ADC 具有战略兴趣。此举使 GSK 与辉瑞等主要参与者在开发针对这些癌症的有效治疗方法的竞争中处于竞争状态。最近，DREAMM-7 III 期试验表明，GSK 的 Blenrep （belantamab mafodotin）联合硼替佐米和地塞米松治疗复发/难治性多发性骨髓瘤方面有显著改善。与标准护理组合相比，这种组合几乎使中位无进展生存期增加了两倍，显示疾病进展或死亡风险降低了 59%。该试验还表明，总生存期获益呈强劲趋势，死亡风险降低了 43%。这些发现突出了 Blenrep 在首次复发时或之后重新定义多发性骨髓瘤治疗策略的潜力。 MBrace 这家生物技术公司正在积极致力于 ADC 领域，专注于 MBRC-101，该药物针对 EphA5（肝配蛋白 A 型受体 5）受体酪氨酸激酶。靶向 EphA5 的意义在于其在多种实体瘤中普遍存在，例如三阴性乳腺癌（TNBC）和非小细胞肺癌（NSCLC），使其成为 ADC 开发的重要靶点。 MBRC-101 的基础在于其特异性靶向 EphA5（一种膜相关酪氨酸激酶受体）的能力。这种特异性对于癌症的治疗至关重要，因为与正常细胞相比，EphA5 在肿瘤细胞中的表达差异，为选择性癌细胞靶向和治疗提供了途径。MBRC-101 采用与单甲基 auristatin E （MMAE）偶联的人源化抗 EphA5 IgG1 抗体，MMAE 是一种有效的细胞毒剂。在与癌细胞上的 EphA5 结合后，MBRC-101 被内化，将 MMAE 直接递送到癌细胞中以诱导细胞死亡。 MBRC-101 的临床前数据令人信服，在乳腺癌模型中显示出显着的疗效。它已显示出与 EphA5 的独家结合、快速内化和对表达 EphA5 的细胞的细胞毒性。在患者来源的 TNBC 异种移植小鼠模型中，MBRC-101 表现出剂量依赖性、稳健且可重复的抗肿瘤活性，为其临床开发提供了强有力的依据。值得注意的是，MBRC-101 在临床前模型中在不同剂量下的耐受性良好，毒理学结果归因于 MMAE 有效载荷，而不是靶点本身。 MBrace Therapeutics 目前正在通过 1/1b 期临床试验推进 MBRC-101，旨在确定最佳生物学相关剂量并评估 MBRC-101 在 TNBC、NSCLC 和其他实体瘤中的安全性和初步活性。在财务方面，MBrace Therapeutics 最近在 B 轮融资中筹集了 8500 万美元，以进一步开发其肿瘤学产品线。牛津生物 Oxford Biotherapeutic （OBT）领先的 ADC 之一 OBT076 靶向 CD205 受体，该受体在一系列实体瘤和液体瘤中过表达。这种创新方法旨在治疗头颈部腺样囊性癌（ACC），这是一种罕见的侵袭性癌症类型。OBT 与 GORTEC 合作，正在进行一项 1b 期试验，以研究 OBT076 作为单一疗法和与 PD-1（程序性细胞死亡蛋白 1）阻断抗体 balstilimab 联合使用。这项试验因其专注于治疗选择有限的癌症而引人注目。此外，OBT 与 Boehringer Ingelheim 的合作促成了 BI 764532 的开发，这是一种靶向 DLL3（Delta 样配体 3）的研究性 T 细胞接合器，DLL3 是使用 OBT 专有的 OGAP 平台发现的一种蛋白质。这种合作伙伴关系已经取得了重要的里程碑，包括获得美国 FDA 的快速通道资格，用于治疗晚期或转移性肺神经内分泌癌（LCNEC-Lung）。 OBT 的 ADC 开发工作以 OGAP 平台（癌症特异性膜蛋白库）为基础，有助于识别癌症靶标的新型、高特异性抗原。这个广泛的数据库支持 OBT 开发基于 ADC 的疗法的战略。辉瑞/Seagen 辉瑞于 2023 年 12 月 14 日完成对 Seagen 的收购，价值约 430 亿美元，标志着辉瑞肿瘤学能力的重大扩展。这一战略举措进一步确立了辉瑞作为肿瘤学领域领先公司的地位，加速下一代癌症治疗方法的开发。此次收购将 Seagen 的开创性 ADC 技术与辉瑞的广泛能力和专业知识相结合。 Seagen 在收购时的投资组合包括四种已获批准的癌症疗法，2022 年的总销售额接近 20 亿美元。此次收购不仅为辉瑞的肿瘤产品组合增加了重要价值，其中包括超过 25 种已批准的药物和生物仿制药，涵盖 40 多个适应症，而且还使辉瑞的肿瘤产品线翻了一番，达到 60 个项目。这些项目涵盖多种模式，包括 ADC、小分子、双特异性和其他免疫疗法，有望对多种癌症类型产生广泛影响。 Seagen 最先进和最著名的 ADC 之一是 Tivdak （tisotumab vedotin-tftv），它已获得 FDA 批准，用于治疗化疗后进展的复发性或转移性宫颈癌。Tivdak 代表了宫颈癌治疗的重大进步，标志着第一个获批用于该适应症的 ADC。这是 Seagen 第三款获得监管部门批准的 ADC，展示了该公司在 ADC 领域的领导地位和创新能力。除了 Tivdak，Seagen 还参与了其他新型 ADC 的开发，包括 SGN-B7H4V，它针对在各种实体恶性肿瘤中过表达的 T 细胞检查点配体 B7-H4。罗氏罗氏著名的 ADC 之一是 Kadcyla（曲妥珠单抗 emtansine），旨在直接向 HER2 阳性癌细胞提供有效的化疗。Kadcyla 已在包括美国和欧盟在内的 100 多个国家/地区获得批准，用于治疗既往接受过赫赛汀和紫杉烷类化疗的 HER2 阳性晚期乳腺癌患者。它还被批准用于新辅助治疗（包括基于赫赛汀和紫杉烷类药物的化疗）后有残留浸润性疾病的 HER2 阳性早期乳腺癌的辅助治疗。罗氏开发的另一种重要 ADC 是 Polivy （polatuzumab vedotin），这是一种获批与苯达莫司汀加利妥昔单抗联合使用的抗 CD79b 抗体-药物偶联物。它用于治疗不适合造血干细胞移植的复发或难治性弥漫性大 B 细胞淋巴瘤成人患者。罗氏还通过战略合作伙伴关系和投资推进 ADC 技术和癌症治疗。例如，罗氏已与 Moma Therapeutics 达成重要合作，投入超过 20 亿美元用于开发精准癌症药物。这笔交易突显了罗氏的战略，即利用外部专业知识和平台来确定与癌细胞生长和存活有关的新药靶点，以开发下一代精准药物。另一项合作是与 MediLink Therapeutics 公司合作开发 YL211，这是一种针对实体瘤的下一代 ADC。MediLink 将其专有的肿瘤微环境可激活 LINker-payload （TMALIN） ADC 技术平台引入合作伙伴关系，专注于 c-间充质上皮转化因子（c-Met）作为该疗法的靶点。罗氏将拥有开发、生产和营销 YL211 的独家国际权利，进一步巩固其在 ADC 和肿瘤学领域的地位。该协议包括向 MediLink 支付总计 5000 万美元的预付和近期里程碑付款，潜在的开发、监管和商业里程碑高达 10 亿美元，以及未来产品净销售额的特许权使用费。武田制药武田制药一直积极参与 ADC 的开发和商业化。其中一项值得注意的合作是与 ImmunoGen 的合作，武田获得了将 ImmunoGen 的新型 ADC 技术（包括新型 DNA 作用 IGN 有效载荷剂）用于最多两个未公开靶点的独家权利。ImmunoGen 收到了武田的预付款，有可能获得总额高达 2.1 亿美元的里程碑付款，外加任何 ADC 产品的商业净销售额的特许权使用费。该公司还扩大了与 Mersana Therapeutics 的合作伙伴关系，旨在推进 Fleximer ADC 的开发，包括靶向 HER2 表达肿瘤的 XMT-1522。此次合作不仅授予武田在美国和加拿大以外对 Mersana 主要候选产品的权利，而且还为其他靶点提供了对 Mersana 的 Fleximer ADC 平台的访问权限。此外，武田和Seagen强调了ADCETRIS （brentuximab vedotin）治疗晚期霍奇金淋巴瘤的重要性。ADCETRIS已在70多个国家获批用于治疗复发或难治性霍奇金淋巴瘤和全身性间变性大细胞淋巴瘤（sALCL）。它正在 70 多项临床试验中进行评估，表明它在治疗 CD30 阳性恶性肿瘤方面具有广泛的潜力。最近，武田还与 Innate Pharma 签订了独家许可协议，以开发针对乳糜泻的ADC。武田已同意向Innate Pharma支付500万美元的预付款，在开发、监管和商业里程碑方面可能达到高达4.1亿美元的费用，外加通过此次合作开发的任何商业产品的净销售额的特许权使用费。这笔交易是武田解决乳糜泻问题的更广泛战略的一部分，这是其自 2019 年以来的第四项举措，旨在开发该病的候选药物。该协议授予武田使用Innate抗体研究、开发、制造和商业化ADC的全球独家权利，这标志着武田将ADC技术从传统肿瘤学应用扩展到乳糜泻等自身免疫性疾病的重大举措。参考资料：各公司官网 www.labiotech.eu -END- 2025CMC-CHINA药博会 • 展位火热预定中！

并购抗体药物偶联物临床2期申请上市

2024-10-01

·PRNewswire

Conformal Medical Announces Launch of the GLACE Study with Next-Gen CLAAS® AcuFORM™ Left Atrial Appendage Occlusion Device

Study will assess the Company's Next-Generation device under Intracardiac Echocardiography (ICE) imaging for Left Atrial Appendage Occlusion (LAAO) procedures. NASHUA, N.H., Oct. 1, 2024 /PRNewswire/ -- Conformal Medical, Inc. today announced the initiation of the GLACE Study. This European study* aims to assess the use of intracardiac echocardiography (ICE) imaging of the left atrial appendage (LAA) during appendage closure procedures with the next-generation CLAAS® AcuFORM™ device in patients with non-valvular atrial fibrillation. The prospective, multicenter, non-randomized, single-arm investigation will enroll approximately 80 patients in Denmark, Italy, and the Czech Republic. Continue Reading "Simplified sizing and ease of use enabled by this device will drive improved workflow in the lab." Post this Conformal CLAAS AcuFORM LAAO Initial patients were treated by the study's co-principal investigators Professor Jens Erik Nielsen-Kudsk, M.D. of Aarhus University Hospital and Professor Ole De Backer, M.D. of Rigshospitalet, Copenhagen University Hospital at their respective institutions in Denmark. Additionally, Shephal Doshi, M.D., from Providence Saint John's Health Center and the Pacific Heart Institute in Santa Monica, California and Principal Investigator of the CONFORM Pivotal Trial was present for the initial cases. "I am excited about the new CLAAS AcuFORM implant and the ability to confirm seal with angiography providing procedural confidence, ensuring the patient has been properly treated," stated Nielsen-Kudsk. "ICE has become our primary imaging platform for LAAO, the GLACE Study allows us to validate the use of ICE with this innovative technology." ICE imaging facilitates real-time visualization of cardiac structures during LAAO closure, enhancing precision while reducing radiation exposure and procedure time. This approach often eliminates the need for general anesthesia, improving patient comfort and operational efficiency."The CLAAS AcuFORM device enhances and simplifies the procedure, with only two sizes, one of which effectively treats over 90% of patients," stated Dr. Doshi. "Simplified sizing and ease of use enabled by this device will drive improved workflow in the lab."Designed to optimize anchor penetration and featuring an improved ePTFE material, and a simplified delivery system, the CLAAS AcuFORM LAAO System builds upon the novel CLAAS device and is engineered to conform to and seal the LAA with its proprietary foam-based architecture. The implant addresses the clinical spectrum of LAA anatomies with only two sizes. The system aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram (TEE) so that physicians may perform the procedure without general anesthesia, a significant advancement with the potential to shift clinical practice to a same-day, single-operator procedure. Over 350 patients have been successfully implanted with the Conformal CLAAS System as part of early feasibility studies and the ongoing CONFORM Pivotal Trial."The use of ICE imaging in LAAO is growing significantly and will continue," said James Reinstein, President and CEO of Conformal Medical. "Our next-generation LAAO technology conforms to individual anatomies, enabling clinicians to simplify the procedure with 2 sizes, the ability to confirm seal, and eliminate general anesthesia & intubation." About Conformal MedicalConformal Medical, Inc., is a medical device company developing devices to prevent stroke in patients with non-valvular atrial fibrillation. The company's proprietary technology is intended to make left atrial appendage closure a same-day, single-operator procedure. For more information, visit . About Left Atrial Appendage ClosureMore than six million people in the United States suffer from Afib, placing them at an increased risk of stroke.1 Current standard of care for stroke prevention is chronic oral anticoagulants, which are not well accepted by patients due to concern about associated risk of bleeding. Left Atrial Appendage Occlusion (LAAO) is emerging as an important alternative to blood thinners for preventing strokes in patients with non-valvular Afib. First-generation LAAO devices are an estimated $1.4B global market in 2023 and are expected to grow to over $6B by 2030.2,3 CAUTION: Investigational Device. The CLAAS System is limited by Federal (or United States) law to investigational use*Study is designed to comply with EU MDR Chapter VI, Article 62 4(i). Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20. Piper Sandler Market Analyst Report, September 2023. Boston Scientific Investor Update, September 2023. SOURCE Conformal Medical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-09-02

·drugs

Endometriosis Linked to Higher Heart Risks for Women

MONDAY, Sept 2, 2024 -- Endometriosis can be a painful, debilitating condition for many women, but new research suggests even more serious consequences: higher odds for heart attacks or strokes. Endometriosis occurs when uterine tissue that normally grows on the inside of the organ grows outside of it instead. Cysts, scar tissue and other conditions can infiltrate nearby organs, resulting in pain and troubles with fertility, according to the Mayo Clinic . The new Danish study was led by Dr. Eva Havers-Borgersen , from Rigshospitalet Copenhagen University Hospital, in Copenhagen. Her team presented its findings Thursday in London at the annual meeting of the European Society of Cardiology. "One in three women die from cardiovascular disease and one in 10 women suffer from endometriosis ," she said in a meeting news release. "Our results suggest that it may be time to routinely consider the risk of cardiovascular disease in women with endometriosis." The study looked at information from a Danish database that identified endometriosis cases among over 60,000 women from 1977 through 2021. The team then compared rates of heart attack and stroke for those women to rates among more than 242,000 women without endometriosis, matched for age. The women's health was followed for an average of 16 years. Women with endometriosis had a 35% higher odds for heart attack and a 20% higher risk for an ischemic (caused by a clot) stroke, compared to women without the condition, the study found. Endometriosis also appeared to raise the odds for a heart arrhythmia by 21% and heart failure by 11%, the Danish team found. "These results provide more evidence that female-specific risk factors and cardiovascular disease in women need greater attention," Havers-Borgersen said. "We suggest that women with endometriosis undergo cardiovascular disease risk assessment, and it is now time for female-specific risk factors -- such as endometriosis, but also gestational diabetes and preeclampsia -- to be considered in cardiovascular risk prediction models." Because these findings were presented at a medical meeting, they should be considered preliminary until published in a peer-reviewed journal. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

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