Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites by Thomas Kayser, MD, BS, Ronald Smulders, MD, PhD, Tomohiro Kusawake, PhD, Erik Wambre, PhD, Gurunadh R. Chichili, PhD, Mary B. Blauwet, DrPH, Anna Spence, MS, Melanie Patton, BS, Rima Tabash, PhD, Hannah A. DeBerg, PhD, Sugandhika Khosa, MS, Philipp Badorrek, MD, Jens M. Hohlfeld, MD, Brian C. Ferslew, PharmD, PhD

“…The novel LAMP (lysosomal-associated membrane protein)-based DNA vaccine ASP2390 targets major HDM allergens, potentially shifting immune responses toward nonallergic pathways and minimizing the risk of atopy, with positive safety and efficacy signals in preclinical models. Objective: We evaluated the safety, tolerability, and efficacy of first-in-human intradermal ASP2390 in adults with HDM allergy. …”
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Oxygenation targets for endovascular therapy in acute ischemic stroke patients (Oxy-TARGET): protocol for a single-centre, open-label randomised controlled trial by Anxin Wang, Zhengfang Hu, Ruquan Han, Fa Liang, Youxuan Wu, Minyu Jian, Xinyan Wang, Yunzhen Wang, Haiyang Liu, Xuan Hou, Kangda Zhang, Zihui Zhang

“…Introduction Preclinical studies have shown that oxygen therapy can improve ischaemic brain tissue oxygen tension, reduce reperfusion injury after revascularisation, promote neuroregeneration and inhibit inflammatory responses potentially exerting a beneficial effect after endovascular treatment (EVT) in patients with acute ischaemic stroke (AIS). …”
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A first evaluation of the efficacy of minibeam radiation therapy combined with an immune check point inhibitor in a model of glioma-bearing rats by Lorea Iturri, Emmanuel Jouglar, Cristèle Gilbert, Julie Espenon, Marjorie Juchaux, Yolanda Prezado

“…One example is minibeam radiation therapy (MBRT). Preclinical experiments have shown that MBRT leads to a remarkable widening of the therapeutic window for GBM and elicits an effective immune priming. …”
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Physiochemical and functional evaluation of the first-in-class anti-cancer IgE antibody drug, MOv18, through process development and good manufacturing practice production by Heather J Bax, Jitesh Chauhan, Alexandra J McCraw, Melanie Grandits, Chara Stavraka, Heike Lentfer, Tim Hillyer, Simon Carroll, Kim Vigor, Chris Selkirk, Mariangela Figini, Jack Cheeseman, Paulina A Urbanowicz, Richard A Gardner, Daniel I R Spencer, Nigel Westwood, Sarah Mellor, James Spicer, Debra H Josephs, Sophia N Karagiannis

“…Antibodies used for cancer therapy are monoclonal IgGs, but tumor-targeting IgE antibodies have shown enhanced effector cell potency against cancer in preclinical models. Research-grade recombinant IgE antibodies have been generated and studied for several decades. …”
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The effect of gut microbiome-targeted therapies in nonalcoholic fatty liver disease: a systematic review and network meta-analysis by Yijia Song, Yijia Song, Yijia Song, Sutong Liu, Lihui Zhang, Lihui Zhang, Wenxia Zhao, Yuanmei Qin, Yuanmei Qin, Minghao Liu

“…BackgroundThe incidence of NAFLD is increasing. Preclinical evidences indicate that modulation of the gut microbiome could be a promising target in nonalcoholic fatty liver disease.MethodA systematic review and network meta-analysis was conducted to compare the effect of probiotics, synbiotics, prebiotics, fecal microbiota transplant, and antibiotics on the liver-enzyme, metabolic effects and liver-specific in patients with NAFLD. …”
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CPEB4 modulates liver cancer progression by translationally regulating hepcidin expression and sensitivity to ferroptosis by M. Eugenia Delgado, Salvador Naranjo-Suarez, Marta Ramírez-Pedraza, Beatriz I. Cárdenas, Carmen Gallardo-Martínez, Alexandra Balvey, Eulalia Belloc, Judit Martín, Mark Boyle, Raúl Méndez, Mercedes Fernandez

“…Limitations of the study include the need for further clinical validation to confirm these preclinical findings in human disease contexts.…”
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Safety and tolerability of the M2 muscarinic acetylcholine receptor modulator BAY 2413555 in heart failure with reduced ejection fraction in the REMOTE-HF study by Marat Fudim, Muhammad Shahzeb Khan, Dominik Linz, JoAnn Lindenfeld, Calum MacRae, Nina Kimmeskamp-Kirschbaum, Michaela Meyer, Thomas Mondritzki, Hanna Tinel, Wilfried Dinh, Robert J. Mentz

“…The study was terminated early based on new and unexpected preclinical findings from a chronic animal toxicology study in monkeys in which evidence of increased vascular inflammation was observed, leading to a no longer favorable risk-benefit balance for the intended long-term (i.e., life-long) treatment of heart failure patients. …”
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IMMUnity Unveiled: A Translational NETwork for tackling PARKinson's Disease – IMMUPARKNET [version 2; peer review: 2 approved] by Tamara Saksida, Alessia di Flora, Marina Romero-Ramos, Vladimirs Pilipenko, Laura Muñoz Delgado, Franca Marino, Yasemin Gursoy Ozdemir, Neda Nikolovski, Cristoforo Comi, Dale Lawson, Inês Figueira, Mitilda Gugu, Simona Poletti, Shubhra Acharya, Dogukan Pira

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Dehydrothyrsiferol Against Cutaneous Leishmaniasis: Treatment Outcome in a Murine Model by Atteneri López-Arencibia, Carlos J. Bethencourt-Estrella, Desirée San Nicolás-Hernández, Rubén L. Rodríguez-Expósito, Angélica Domínguez-de-Barros, Lizbeth Salazar-Villatoro, Maritza Omaña-Molina, Francisco Cen-Pacheco, Ana R. Díaz-Marrero, José J. Fernández, Elizabeth Córdoba-Lanús, Jacob Lorenzo-Morales, José E. Piñero

“…One of the most important steps in preclinical drug discovery is to demonstrate the in vivo efficacy of potential leishmanicidal compounds and good characteristics at the level of parasite killing prior to initiating human clinical trials. …”
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An automated platform for simultaneous, longitudinal analysis of engineered neuromuscular tissues for applications in neurotoxin potency testing by Jacob W. Fleming, Molly C. McCloskey, Kevin Gray, David R. Nash, Vincent Leung, Christos Michas, Shawn M. Luttrell, Christopher Cavanaugh, Julie Mathieu, Shawn Mcquire, Mark Bothwell, David L. Mack, Nicholas A. Geisse, Alec S.T. Smith

“…Challenges with scarcity, scalability, throughput, and ethical considerations further limit the suitability of animal models for preclinical screening. Engineered models have emerged as alternatives for studying NMJ functionality in response to genetic and/or pharmacological challenge. …”
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The factors impacting on Gleason score upgrading in prostate cancer with initial low Gleason scores by Tzu-Heng Huang, Wei-Ming Li, Hung-Lung Ke, Ching-Chia Li, Wen-Jeng Wu, Hsin-Chih Yeh, Yen-Chun Wang, Hsiang-Ying Lee

“…To further explore preclinical variables, a cut-off value for PV (≤ 38 ml, p value = 0.0017) and PSAD (≥ 0.26 ng/ml2, p value = 0.0013) were identified to be associated with GS upgrading. …”
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Impact of family socio-economic status on the prognosis of heart transplantation in children by Shun Liu, Han Mo, Yiqi Zhao, Xiao Chen, Weiteng Wang, Yijing Li, Ningning Zhang, Mengni Bao, Zeyu Cui, Qian Zhao, Jun Yan, Xiumeng Hua, Jiangping Song

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Vectorized Treg-depleting αCTLA-4 elicits antigen cross-presentation and CD8+ T cell immunity to reject ‘cold’ tumors by Laetitia Fend, Eric Quemeneur, Monika Semmrich, Jean-Baptiste Marchand, Matilda Rehn, Nathalie Silvestre, Linda Mårtensson, Johann Foloppe, Ingrid Teige, Björn Frendeus, Petra Holmkvist, Carolin Svensson, Christelle Remy, Patricia Kleinpeter, Jules Deforges, Fred Junghus, Kirstie L Cleary, Mimoza Bodén

“…At a mechanistic level, accumulating preclinical and clinical data indicate dual mechanisms for αCTLA-4; ICB and regulatory T cell (Treg) depletion are both thought to contribute efficacy and toxicity in available, systemic, αCTLA-4 regimens. …”
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Ibuprofen reduces inflammation, necroptosis and protects photoreceptors from light-induced retinal degeneration by Ping-Wu Zhang, Zi-He Wan, Weifeng Li, Abhishek Vats, Kunal Mehta, Laura Fan, Lingli Zhou, Sean Li, Gloria Li, Casey J. Keuthan, Cynthia Berlinicke, Cheng Qian, Noriko Esumi, Elia J Duh, Donald J. Zack

“…Unfortunately, current treatments for these diseases are limited at best. Genetic and other preclinical evidence suggest a relationship between retinal degeneration and inflammation. …”
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Biochemical mechanisms and molecular interactions of vitamins in cancer therapy by Abdullahi T. Aborode, Isreal A. Onifade, Mercy M. Olorunshola, Gladys O. Adenikinju, Ibude J. Aruorivwooghene, Adeboboye C. Femi, Osasere Jude-Kelly Osayawe, Abraham Osinuga, Ebenezer A. Omojowolo, Adekunle F. Adeoye, Segun Olapade, Ibrahim O. Adelakun, Ogundepo D. Moyinoluwa, Oluwatosin M. Adeyemo, Godfred Y. Scott, Ruth A. Ogbonna, Emmanuel A. Fajemisin, Omama Ehtasham, Soyemi Toluwalashe, Adetolase A. Bakre, Ridwan O. Adesola, Seto C. Ogunleye, Nnenna R. Anyanwu, Terungwa H. Iorkula

“…Individualized supplementation plans guided by medical knowledge are crucial to achieving optimal results in clinical and preclinical settings. In this review, we critically evaluated the effects of different vitamins on the risk and development of cancer. …”
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Exploring Azithromycin’s Neuroprotective Role in Traumatic Brain Injury: Insights into Cognitive and Motor Recovery and Neuroinflammatory Modulation by Mohannad A. Almikhlafi, Nehad A. Abdallah, Aakash Kumar, Tarun Sharma, Zuber Khan, Haifa A. Fadil, Sultan Althagfan, Ahmed K. B. Aljohani, Sara A. Almadani, Samar F. Miski, Tahani Saeedi, Rayan S. Alharbi, Abdulrahman M. Al-Harthe, Mohammed H. Alsubhi, Hanaa Wanas, Ahmed Aldhafiri, Sidharth Mehan, Hossein M. Elbadawy

“…Conclusions: AZI was shown to interfere with several pathways involved in TBI’s pathophysiology. While preclinical results are promising, further studies are necessary to establish the long-term safety and efficacy of AZI in a clinical setting. …”
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The fungal microbiota modulate neonatal oxygen-induced lung injury by Isaac Martin, Mary Silverberg, Ahmed Abdelgawad, Kosuke Tanaka, Brian A. Halloran, Teodora Nicola, Erin D. Myers, Jay P. Desai, Catrina T. White, Ibrahim Karabayir, Oguz Akbilgic, Laura Tipton, Samuel J. Gentle, Namasivayam Ambalavanan, Brian M. Peters, Luan D. Vu, Viral G. Jain, Charitharth V. Lal, Stephania A. Cormier, Joseph F. Pierre, Tamás Jilling, Ajay J. Talati, Kent A. Willis

“…Results Here, we show that the fungal microbiota modulates hyperoxia-induced lung injury severity in very low birth weight premature infants and preclinical pseudohumanized and altered fungal colonization mouse models. …”
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Low-activity [18F]-somatostatin receptor (SSTR) imaging using [18F]SiTATE on a long axial field-of-view PET/CT scanner by Nils F. Trautwein, Eduardo Calderón, Pia M. Linder, Gerald Reischl, Philippe Driessen, Wenhong Lan, Andreas S. Brendlin, Thorben Groß, Helmut Dittmann, Martina Hinterleitner, Christian la Fougère, Fabian P. Schmidt, Lena S. Kiefer

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PPARα suppresses growth of hepatocellular carcinoma in a high-fat diet context by reducing neutrophil extracellular trap release by Banglun Pan, Zhu Zhang, Dongjie Ye, Xiaoxia Zhang, Yuxin Yao, Yue Luo, Haijie Hong, Xinran Cai, Yanling Chen, Nanhong Tang

“…Impact and implications:: We have identified PPARα and its agonists as therapeutic targets for controlling the neutrophil extracellular traps associated with high lipid metabolism. Results from preclinical models suggest that PPARα can limit mitochondrial oxidative stress, inhibit cGAS-STING-NF-κB signaling, and limit the release of neutrophil extracellular traps, thereby increasing the contact of anti-tumor leukocytes and hepatocellular cancer cells and limiting tumor growth.…”
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Development of a TCR-like antibody and chimeric antigen receptor against NY-ESO-1/HLA-A2 for cancer immunotherapy by Xin Liu, Yang Du, Ningyan Zhang, Zhiqiang An, Wei Xiong, Yixiang Xu, Bingnan Yin, Yuqian Huang, Junjun Chu, Changsheng Xing, Chen Qian, Tianhao Duan, Helen Y Wang, John S. Yu, Rongfu Wang

“…The second-generation CAR-T cells engineered from 2D2 specifically recognized and eliminated A2+/NY-ESO-1+tumor cells in vitro, inhibited tumor growth, and prolonged the overall survival of mice in TNBC and primary melanoma tumor model in vivo.Conclusions This study showed the specificity of the antibody identified from human scFv phage library and demonstrated the potential antitumor activity by TCR-like CAR-T cells both in vitro and in vivo, warranting further preclinical and clinical evaluation of the TCR-like antibody in patients. …”
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