{"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":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Protocol registration: </strong>www.crd.york.ac.uk/prospero identifier is CRD42024504358.</p>","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}
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":"<p><strong>Introduction: </strong>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.</p><p><strong>Areas covered: </strong>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.</p><p><strong>Expert opinion: </strong>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.</p>","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}
Nada Chaoul, Eleonora Lauricella, Andrea Giglio, Gabriella D'Angelo, Carlo Ganini, Mauro Cives, Camillo Porta
{"title":"The future of cellular therapy for the treatment of renal cell carcinoma.","authors":"Nada Chaoul, Eleonora Lauricella, Andrea Giglio, Gabriella D'Angelo, Carlo Ganini, Mauro Cives, Camillo Porta","doi":"10.1080/14712598.2024.2418321","DOIUrl":"10.1080/14712598.2024.2418321","url":null,"abstract":"<p><strong>Introduction: </strong>Systemic treatment options for renal cell carcinoma (RCC) have expanded considerably in recent years, and both tyrosine kinase inhibitors and immune checkpoint inhibitors, alone or in combination, have entered the clinical arena. Adoptive cell immunotherapies have recently revolutionized the treatment of cancer and hold the promise to further advance the treatment of RCC.</p><p><strong>Areas covered: </strong>In this review, we summarize the latest preclinical and clinical development in the field of adoptive cell immunotherapy for the treatment of RCC, focusing on lymphokine-activated killer (LAK) cells, cytokine-induced killer (CIK) cells, tumor-infiltrating T cells (TILs), TCR-engineered T cells, chimeric antigen receptor (CAR) T cells, and dendritic cell vaccination strategies. Perspectives on emerging cellular products including CAR NK cells, CAR macrophages, as well as γδ T cells are also included.</p><p><strong>Expert opinion: </strong>So far, areas of greater therapeutic success of adoptive cell therapies include the adjuvant administration of CIK cells and the transfer of anti-CD70 CAR T cells in patients with metastatic RCC. Bench to bedside and back research will be needed to overcome current limitations of adoptive cell therapies in RCC, primarily aiming at improving the safety of immune cell products, optimizing their antitumor activity and generating off-the-shelf products ready for clinical use.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1245-1259"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557430","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}
{"title":"Recent developments and industry interest in gene therapy for Duchenne muscular dystrophy.","authors":"Hidenori Moriyama, Toshifumi Yokota","doi":"10.1080/14712598.2024.2422998","DOIUrl":"10.1080/14712598.2024.2422998","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1189-1191"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497638","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}
{"title":"Stem cell therapy for type-2 diabetes: keeping the pedal to the metal to deliver translation to the clinic.","authors":"Ning Yang, LaTonya J Hickson, Lilach O Lerman","doi":"10.1080/14712598.2024.2422358","DOIUrl":"10.1080/14712598.2024.2422358","url":null,"abstract":"","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1183-1187"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11606765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Denis T Balaban, Michael Levy, Ray Borrow, Monique R Anderson
{"title":"An evaluation of ravulizumab for the treatment of neuromyelitis optica spectrum disorder.","authors":"Denis T Balaban, Michael Levy, Ray Borrow, Monique R Anderson","doi":"10.1080/14712598.2024.2423002","DOIUrl":"10.1080/14712598.2024.2423002","url":null,"abstract":"<p><strong>Introduction: </strong>Following the CHAMPION-NMOSD trial, the FDA recently granted approval for ravulizumab, a humanized monoclonal antibody against complement C5 protein in AQP-4 seropositive neuromyelitis optica spectrum disorder (NMOSD). Similar to eculizumab, ravulizumab offers near-complete prevention of NMOSD relapses, but has a longer half-life, providing decreased infusion frequency and increased convenience for patients. While targeting the complement pathway has clear advantages, patients are at risk for infection with encapsulated organisms, in particular <i>Neisseria meningitidis</i>.</p><p><strong>Areas covered: </strong>In this paper, we discuss the details of the CHAMPION-NMOSD trial and discuss challenges in meningitis prevention and strategies for switching therapies.</p><p><strong>Expert opinion: </strong>Ravulizumab improves on eculizumab's success as a highly effective NMOSD therapy by decreasing infusion frequency, thereby increasing patient convenience. We predict that ravulizumab will eventually replace eculizumab but may not have a similar impact on inebelizumab or satralizumab. Patients taking C5 complement inhibitors have an increased risk of serious meningococcal infections, such as invasive meningococcal disease (IMD), and have incomplete protection against IMD despite immunization. Thus, we recommend that in addition to standard pre-immunizations against <i>Neisseria meningitidis</i>, patients should also be assessed for starting on appropriate antibiotic prophylaxis against IMD, based on local resistance patterns.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1193-1198"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497635","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}
{"title":"Optimization of radiation target volume for locally advanced esophageal cancer in the immunotherapy era.","authors":"Jian Zheng, Zhunhao Zheng, Tian Zhang, Xi Chen, Qingsong Pang, Ping Wang, Cihui Yan, Wencheng Zhang","doi":"10.1080/14712598.2024.2423009","DOIUrl":"10.1080/14712598.2024.2423009","url":null,"abstract":"<p><strong>Introduction: </strong>Locally advanced esophageal cancer (EC) has poor prognosis. Preliminary clinical studies have demonstrated the synergistic efficacy of radiotherapy combined with immunotherapy in EC. Adjusting the radiotherapy target volume to protect immune function favors immunotherapy. However, there is no clear consensus on the exact definition of the EC target volume.</p><p><strong>Areas covered: </strong>Preclinical studies have provided a wealth of information on immunotherapy combined with different radiotherapy modalities, and several clinical studies have evaluated the impact of immunotherapy combined with radiotherapy on locally advanced EC. Here, we illustrate the rational target volume delineation for radiotherapy in terms of patient prognosis, pattern of radiotherapy failure, treatment-related toxicities, tumor-draining lymph nodes, and systemic immunity and summarize the clinical trials of radiotherapy combined with immunotherapy in EC.</p><p><strong>Expert opinion: </strong>We recommend applying involved-field irradiation (IFI) instead of elective nodal irradiation (ENI) for irradiated fields when immunotherapy is combined with chemoradiotherapy (CRT) for locally advanced EC. We expect that this target design will be evaluated in clinical trials to further explore more precise diagnostic modalities, long-term toxic responses, and quality of survival, and stratification factors for personalized treatment, and to provide more treatment benefits for patients.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1221-1232"},"PeriodicalIF":3.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497637","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}
Edward Tobinick, Danielle Ucci, Kirsten Bermudo, Samantha Asseraf
{"title":"Perispinal etanercept stroke trial design: PESTO and beyond.","authors":"Edward Tobinick, Danielle Ucci, Kirsten Bermudo, Samantha Asseraf","doi":"10.1080/14712598.2024.2390636","DOIUrl":"10.1080/14712598.2024.2390636","url":null,"abstract":"<p><strong>Introduction: </strong>Perispinal etanercept (PSE) is an innovative treatment designed to improve stroke recovery by addressing chronic post-stroke neuroinflammation. Basic science evidence, randomized clinical trial (RCT) evidence and 14 years of favorable clinical experience support the use of PSE to treat chronic stroke. This article provides guidance for the design of future PSE RCTs in accordance with current FDA recommendations.</p><p><strong>Areas covered: </strong>Scientific background and essential elements of PSE RCT design.</p><p><strong>Expert opinion: </strong>Intimate familiarity with PSE, its novel method of drug delivery, and the characteristics of ideal enriched study populations are necessary for those designing future PSE stroke trials. The design elements needed to enable a PSE RCT to generate valid results include a suitable research question; a homogeneous study population selected using a prospective enrichment strategy; a primary outcome measure responsive to the neurological improvements that result from PSE; trialists with expertise in perispinal delivery; optimal etanercept dosing; and steps taken to minimize the number of placebo responders. RCTs failing to incorporate these elements, such as the PESTO trial, are incapable of reaching reliable conclusions regarding PSE efficacy. SF-36 has not been validated in PSE trials and is unsuitable for use as a primary outcome measure in PSE RCTs.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1095-1108"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035597","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}
Gilda Gaudio, Enzo Martino, Gloria Pellizzari, Matteo Cavallone, Grazia Castellano, Abeid Omar, Lika Katselashvili, Dario Trapani, Giuseppe Curigliano
{"title":"Developing combination therapies with biologics in triple-negative breast cancer.","authors":"Gilda Gaudio, Enzo Martino, Gloria Pellizzari, Matteo Cavallone, Grazia Castellano, Abeid Omar, Lika Katselashvili, Dario Trapani, Giuseppe Curigliano","doi":"10.1080/14712598.2024.2408756","DOIUrl":"10.1080/14712598.2024.2408756","url":null,"abstract":"<p><strong>Introduction: </strong>Novel compounds have entered the triple-negative breast cancer (TNBC) treatment algorithm, namely immune checkpoints inhibitors (ICIs), PARP inhibitors and antibody-drug conjugates (ADCs). The optimization of treatment efficacy can be enhanced with the use of combination treatments, and the incorporation of novel compounds. In this review, we discuss the combination treatments under development for the treatment of TNBC.</p><p><strong>Areas covered: </strong>The development of new drugs occurring in recent years has boosted the research for novel combinations to target TNBC heterogeneity and improve outcomes. ICIs, ADCs, tyrosine kinase inhibitors (TKIs), and PARP inhibitors have emerged as leading players in this new landscape, while other compounds like novel intracellular pathways inhibitors or cancer vaccines are drawing more and more interest. The future of TNBC is outlined in combination approaches, and based on new cancer targets, including many chemotherapy-free treatments.</p><p><strong>Expert opinion: </strong>A large number of TNBC therapies have either proved clinically ineffective or weighted by unacceptable safety profiles. Others, however, have provided promising results and are currently in late-stage clinical trials, while a few have actually changed clinical practice in recent years. As novel, more and more selective drugs come up, combination strategies focusing the concept of synergy are fully warranted for the future.</p>","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"1075-1094"},"PeriodicalIF":3.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364935","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}