Expert Opinion on Biological Therapy最新文献_第4页

Bispecific therapeutics: a state-of-the-art review on the combination of immune checkpoint ‎inhibition with costimulatory and non-checkpoint targeted therapy. 双特异性疗法：关于免疫检查点抑制与成本刺激和非检查点靶向疗法相结合的最新综述。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-12-01 Epub Date: 2024-11-18 DOI: 10.1080/14712598.2024.2426636

Samin Mortaheb, Parmida Sadat Pezeshki, Nima Rezaei

{"title":"Bispecific therapeutics: a state-of-the-art review on the combination of immune checkpoint ‎inhibition with costimulatory and non-checkpoint targeted therapy.","authors":"Samin Mortaheb, Parmida Sadat Pezeshki, Nima Rezaei","doi":"10.1080/14712598.2024.2426636","DOIUrl":"10.1080/14712598.2024.2426636","url":null,"abstract":"Introduction: Immune checkpoint inhibitors (ICIs) have revolutionized the field of cancer immunotherapy and have enhanced the survival of patients with malignant tumors. However, the overall efficacy of ICIs remains unsatisfactory and is faced with two major concerns of resistance development and occurrence of immune-related adverse events (irAEs). Bispecific antibodies (bsAbs) have emerged as promising strategies with unique mechanisms of action to achieve a better efficacy and safety than monoclonal antibodies (mAbs) or even their combination. BsAbs along with other bispecific platforms such as bispecific fusion proteins, nanobodies, and CAR-T cells may help to avoid development of resistance and reduce irAEs caused by on-target/off-tumor binding effects of mAbs.Areas covered: A literature search was performed using PubMed for English-language articles to provide a comprehensive overview of preclinical and clinical studies on bsAbs specified for both immune checkpoints and non-checkpoint molecules as a well-enhanced class of therapeutics.Expert opinion: Identifying suitable targets and selecting effective engineering platforms enhance the potential of bsAbs to address the challenges associated with conventional therapies such as ICIs, positioning them as a promising class of therapeutics in the landscape of cancer immunotherapy.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1335-1351"},"PeriodicalIF":3.6,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

An evaluation of risankizumab for the treatment of moderate-to-severe ulcerative colitis. 评估利桑珠单抗治疗中重度溃疡性结肠炎的效果。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-12-01 Epub Date: 2024-11-13 DOI: 10.1080/14712598.2024.2428311

Amanda M Johnson, Edward V Loftus

引用次数: 0

Immunobiology of biliary tract cancer and recent clinical findings in approved and upcoming immune checkpoint inhibitors. 胆道癌的免疫生物学以及已批准和即将批准的免疫检查点抑制剂的最新临床发现。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-12-01 Epub Date: 2024-11-18 DOI: 10.1080/14712598.2024.2431088

Carmelo Laface, Emanuela Fina, Angela Dalia Ricci, Deniz Can Guven, Francesca Ambrogio, Simona De Summa, Elsa Vitale, Raffaella Massafra, Oronzo Brunetti, Alessandro Rizzo

{"title":"Immunobiology of biliary tract cancer and recent clinical findings in approved and upcoming immune checkpoint inhibitors.","authors":"Carmelo Laface, Emanuela Fina, Angela Dalia Ricci, Deniz Can Guven, Francesca Ambrogio, Simona De Summa, Elsa Vitale, Raffaella Massafra, Oronzo Brunetti, Alessandro Rizzo","doi":"10.1080/14712598.2024.2431088","DOIUrl":"10.1080/14712598.2024.2431088","url":null,"abstract":"Introduction: Recently, immunotherapy has offered new hope for treating biliary tract cancer (BTC). However, several issues are to be considered, including the lack of validated predictive biomarkers that could help to identify patient groups which are most likely to benefit from such therapeutic approaches.Areas covered: In the current article, we will provide an overview of recent results and ongoing and future research directions of immunotherapy in BTC, with a special focus on recently published, practice-changing data, and ongoing active and recruiting clinical trials.Expert opinion: At this moment, dozens of clinical trials in phases I to III are evaluating the role of cancer immunotherapy in this setting, with the hope of adding more therapeutic options for BTC patients. Future research must focus on the development of novel agents and combinations, but the validation of biomarkers remains an urgent need. As more research results emerge, novel combinatorial strategies are destined to further transform the treatment paradigm for this heterogeneous and aggressive tumor type.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1363-1374"},"PeriodicalIF":3.6,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Evaluation of orphan maintained biological medicinal products in the European Union between 2018 to 2023: a regulatory perspective. 2018 年至 2023 年欧盟孤儿维护生物药品评估：监管视角。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-11-01 Epub Date: 2024-11-11 DOI: 10.1080/14712598.2024.2422360

Paolo Caferra, Thomas Fraisse, Maria Letizia Trincavelli, Laura Marchetti, Anna Maria Piras

{"title":"Evaluation of orphan maintained biological medicinal products in the European Union between 2018 to 2023: a regulatory perspective.","authors":"Paolo Caferra, Thomas Fraisse, Maria Letizia Trincavelli, Laura Marchetti, Anna Maria Piras","doi":"10.1080/14712598.2024.2422360","DOIUrl":"10.1080/14712598.2024.2422360","url":null,"abstract":"Objectives: Orphan medicinal products (OMPs) authorized by the European Union (EU) benefit from market exclusivity, fee waivers, and national incentives. Maintaining orphan status during a marketing authorization application requires meeting eligibility criteria, especially demonstrating significant benefit (SB), which is challenging. This study identifies key features linked to successful orphan status maintenance for biological OMPs approved in the EU between 2018 and 2023.Methods: Data from European public assessment reports and orphan maintenance assessment reports were analyzed.Results: Among the 50 biological OMP maintained orphan designations, 68.0% had to demonstrate SB over existing treatments, with 91.2% leveraging the clinically relevant advantage area, utilizing better clinical efficacy (83.9%) and efficacy in subpopulations (38.7%) subdomains. However, 32.0% did not need to demonstrate SB due to a lack of alternative treatments, most of which were ultra-orphan drugs. Advanced therapy medicinal products and monoclonal antibodies were the most numerous OMP categories, whereas oncology and immunomodulation were the preferred therapeutic areas.Conclusion: The Orphan Regulation is essential in advancing treatments for rare diseases, fostering innovation while addressing unmet medical needs. Nonetheless, the insufficient return on investment criterion remains underused, whereas refining major contribution to patient care guidelines and incorporating real-world evidence may enhance regulatory evaluations.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1279-1297"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

An evaluation of mirikizumab for the treatment of ulcerative colitis. 米利珠单抗治疗溃疡性结肠炎的评估。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-11-01 Epub Date: 2024-10-16 DOI: 10.1080/14712598.2024.2412650

Christopher White, Peter M Irving

{"title":"An evaluation of mirikizumab for the treatment of ulcerative colitis.","authors":"Christopher White, Peter M Irving","doi":"10.1080/14712598.2024.2412650","DOIUrl":"10.1080/14712598.2024.2412650","url":null,"abstract":"Introduction: Treatment of ulcerative colitis (UC) aims to reduce symptoms and complications by decreasing intestinal inflammation. A proportion of patients do not respond to, do not tolerate, or are inappropriate candidates for current therapies. Interleukin (IL)-23 is a therapeutic target and mirikizumabis the first p19-targeted IL-23 antibody approved for the treatment of moderately to severely active UC.Areas covered: This review summarizes the pro-inflammatory effects of IL-23 and outlines the pharmacokinetics of mirikizumab. It provides a synopsis of the available phase II and phase III evidence for the efficacy and safety of mirikizumab in UC.Expert opinion: The mirikizumab clinical development program demonstrated its superiority over placebo and its favorable safety profile in the treatment of UC. Its positioning in therapeutic algorithms remains to be fully understood but mirikizumab has proven efficacy in both advanced therapy (AT)-naïve and AT-experienced patients. The inclusion in the license of extended induction for non-responders as well as rescue intravenous dosing allows for flexibility in patient with limited primary response and secondary loss of response.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1199-1206"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Dynamics of biological markets with multiple biosimilar competitors in the United States. 美国存在多个生物仿制药竞争者的生物市场动态。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-11-01 Epub Date: 2024-10-09 DOI: 10.1080/14712598.2024.2412648

Morgane C Mouslim, Mariana P Socal, Antonio J Trujillo

{"title":"Dynamics of biological markets with multiple biosimilar competitors in the United States.","authors":"Morgane C Mouslim, Mariana P Socal, Antonio J Trujillo","doi":"10.1080/14712598.2024.2412648","DOIUrl":"10.1080/14712598.2024.2412648","url":null,"abstract":"Background: The dynamics of biological markets with multiple biosimilar competitors in the United States are poorly understood. Moreover, due to confidentiality issues, the relationship between originator biologic net prices, rebates, and biosimilar entry is largely unexplored.Research design and methods: We conducted a review of the Food Drug Administration (FDA) purple book and manufacturer websites to identify all originator biologics with multiple competitors and their characteristics. We leveraged a novel data source to examine originator biologic net prices and rebates over time and used descriptive statistics and interrupted time-series analyses to assess their relationship with biosimilar entry.Results: By December 2022, only five originator biologics had three or more available biosimilar competitors. Mean time between biosimilar approval and biosimilar launch was 9 months (SD = 7.04 months). By third biosimilar competitor, entry net prices for originator biologics had decreased by 9.34% to 50.93%, while rebates had increased by 25.35% to 89.71%.Conclusions: Very few originator biologics have multiple available biosimilar competitors. Barrier to biosimilar availability seems to be at the approval level as the time between approval and launch is relatively short. However, originator biologics respond quickly to biosimilar competition, mainly through an increase in rebates.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1271-1278"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142389160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Probiotic therapy as a promising strategy for gestational diabetes mellitus management. 益生菌疗法是治疗妊娠糖尿病的有效策略。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-11-01 Epub Date: 2024-09-30 DOI: 10.1080/14712598.2024.2409880

Deborah Emanuelle de Albuquerque Lemos, José Luiz de Brito Alves, Evandro Leite de Souza

{"title":"Probiotic therapy as a promising strategy for gestational diabetes mellitus management.","authors":"Deborah Emanuelle de Albuquerque Lemos, José Luiz de Brito Alves, Evandro Leite de Souza","doi":"10.1080/14712598.2024.2409880","DOIUrl":"10.1080/14712598.2024.2409880","url":null,"abstract":"Introduction: Gestational diabetes mellitus (GDM) has become the most common pregnancy medical complication, and its prevalence has increased in recent years. The GDM treatment primarily relies on adopting healthy eating habits, physical exercise, and insulin therapy. However, using probiotics to modulate the gut microbiota has been the subject of clinical trials as a promising therapeutic strategy for GDM management.Areas covered: Due to the adverse effects of gut dysbiosis in women with GDM, strategies targeting the gut microbiota to mitigate hyperglycemia, low-grade inflammation, and adverse pregnancy outcomes have been explored. Probiotic supplementation may improve glucose metabolism, lipid profile, oxidative stress, inflammation, and blood pressure in women with GDM. Furthermore, decreased fasting blood glucose, insulin resistance, and inflammatory markers, such as TNF-α and CRP, as well as increased total antioxidant capacity, lipid profile modulation, and improved blood pressure in women with GDM, are some of the important results reported in the available literature.Expert opinion: To fill the knowledge gap, further studies are needed focusing on modulating gut microbiota composition and metabolic activity and their systemic repercussions in GDM.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1207-1219"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Assessment of cell-binding capacity of shed rAAV particles after gene therapy vector administration: implications for environmental risk and hygiene recommendations. 评估基因治疗载体使用后脱落的 rAAV 粒子与细胞的结合能力：对环境风险和卫生建议的影响。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-11-01 Epub Date: 2024-10-22 DOI: 10.1080/14712598.2024.2418961

Tobias Fleischmann

{"title":"Assessment of cell-binding capacity of shed rAAV particles after gene therapy vector administration: implications for environmental risk and hygiene recommendations.","authors":"Tobias Fleischmann","doi":"10.1080/14712598.2024.2418961","DOIUrl":"10.1080/14712598.2024.2418961","url":null,"abstract":"Background: Currently, adeno-associated viruses (AAVs) are the most commonly used in vivo gene therapy (GT) vector platform. Risks posed to the environment, including the public, have not been well studied in the past. There is uncertainty concerning the necessary level of biocontainment and appropriate hygiene behavior for the handling of secreta/excreta of GT patients during the shedding phase.Research design and methods: Here, feces and urine samples from non-human primates, treated with an AAV9-based vector at 2 × 1013 vector genomes per kilogram body weight (vg/kg), were analyzed for vector presence and subsequently analyzed for their capacity to bind to cells.Results: Both sample types contained particles which bound to cells at concentrations in the range of ~104 (and higher) vg/mL of culture medium. Novel control rAAV vector displayed a ~2-3 orders of magnitude higher affinity to cells than shed particles.Conclusions: The lower binding capacity of the shed vector particles speaks in favor of a more relaxed containment and hygiene approach in the context of GT. It is recommended that current hygiene and contact-avoidance-based containment measures after GT administration are reduced. The results also support the efforts to achieve a simplification of the regulatory review process of medicinal genetically modified organisms.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1299-1309"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A systematic review of the efficacy and safety of anti-amyloid beta monoclonal antibodies in treatment of Alzheimer's disease. 抗淀粉样蛋白 beta 单克隆抗体治疗阿尔茨海默病的疗效和安全性系统综述。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-11-01 Epub Date: 2024-11-12 DOI: 10.1080/14712598.2024.2416947

Akanksha Chhabra, Siddhant Solanki, Prithvi Saravanabawan, Arun Venkiteswaran, NagaTarang Nimmathota, Nishi Manojkumar Modi

{"title":"A systematic review of the efficacy and safety of anti-amyloid beta monoclonal antibodies in treatment of Alzheimer's disease.","authors":"Akanksha Chhabra, Siddhant Solanki, Prithvi Saravanabawan, Arun Venkiteswaran, NagaTarang Nimmathota, Nishi Manojkumar Modi","doi":"10.1080/14712598.2024.2416947","DOIUrl":"10.1080/14712598.2024.2416947","url":null,"abstract":"Introduction: Alzheimer's disease can cause dementia through brain matter degradation. This study investigates the monoclonal antibody usage for AD treatment, following PRISMA 2020 guidelines, and aims to discern the monoclonal antibody that offers the optimal balance of efficacy and safety for individuals with AD.Methods: A systematic search was conducted across databases such as PubMed, Cochrane Library, and clinical trial registries for randomized controlled trials. The quality of studies was assessed using the Cochrane risk of bias 2 tool. Cognitive function and daily activities were evaluated using MMSE, ADAS-Cog, and CDR-SB test data.Results: According to CDR-SB measurements, lecanemab showed effectiveness in reducing brain amyloid and cognitive decline, with a change from baseline of 1.21. Aducanumab resulted in a decrease of -0.39 (-22%). Bapineuzumab showed no significant benefit, with scores of 2.4 (2.8). Gantenerumab, scoring 1.69 (1.37, 2.01), reduces amyloid, particularly in early Alzheimer's stages. Crenezumab was ineffective, with a score of 3.61.Conclusion: The findings provide various perspectives. Lecanemab showed the most promise in brain amyloid reduction and decelerating cognitive decline compared to the other therapies. Further research is needed, highlighting the necessity of AD therapeutic research to alter AD's trajectory and provide reliable treatment.Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42024504358.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1261-1269"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The role of antibody therapies in treating relapsed chronic lymphocytic leukemia: a review. 抗体疗法在治疗复发慢性淋巴细胞白血病中的作用。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-11-01 Epub Date: 2024-10-10 DOI: 10.1080/14712598.2024.2413365

Magdalena Witkowska, Agata Majchrzak, Paweł Robak, Anna Wolska-Washer, Tadeusz Robak

{"title":"The role of antibody therapies in treating relapsed chronic lymphocytic leukemia: a review.","authors":"Magdalena Witkowska, Agata Majchrzak, Paweł Robak, Anna Wolska-Washer, Tadeusz Robak","doi":"10.1080/14712598.2024.2413365","DOIUrl":"10.1080/14712598.2024.2413365","url":null,"abstract":"Introduction: Chronic lymphocytic leukemia (CLL) is one of the most common types of leukemia in adult patients. The landscape of CLL therapy has changed in the last decades with the introduction of antibody-based therapies and novel targeted agents resulting in improved outcomes.Areas covered: This article describes the use of monoclonal antibodies, bispecific antibodies and antibody-drug conjugates in the treatment of relapsed and refractory CLL. The mechanism of action and clinical applications and safety of antibody-based therapies, both as monotherapy and in combination with other drugs, are discussed. A literature search was performed using PubMed, Web of Science, and Google Scholar for articles published in English. Additional relevant publications were obtained by reviewing the references from the chosen articles.Expert opinion: Antibody-based therapeutic strategies have drastically changed the treatment of CLL, as they have introduced the concept of boosting immune responses against tumor cells. While immunotherapy is generally effective, some treatment failure can occur due to antigen loss, mutation, or down-regulation, and this remains the main obstacle to cure. The development of novel antibody therapies, including their combinations with targeted drugs and bispecific antibodies, might help to reduce toxicity and improve efficacy.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1233-1244"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0