Regulatory insights into nanomedicine and gene vaccine innovation: Safety assessment, challenges, and regulatory perspectives

Acta Biomaterialia, Год журнала: 2024, Номер 180, С. 1 - 17

Опубликована: Апрель 10, 2024

This analysis explores the principal regulatory concerns linked to nanomedicines and gene vaccines, including complexities involved perspectives on how navigate them. In realm of nanomedicines, ensuring safety nanomaterials is paramount due their unique characteristics potential interactions with biological systems. Regulatory bodies are actively formulating guidelines standards assess risks associated nanomedicine products, emphasizing need for standardized characterization techniques accurately gauge effectiveness. Regarding frameworks must be tailored address distinct challenges posed by genetic interventions, necessitating special considerations in efficacy evaluations, particularly concerning vector design, target specificity, long-term patient monitoring. Ethical such as autonomy, informed consent, privacy also demand careful attention, alongside intricate matter intellectual property rights, which balanced against imperative widespread access these life-saving treatments. Collaborative efforts among bodies, researchers, patent offices, private sector essential tackle effectively, international cooperation being especially crucial given global scope vaccine development. Striking right balance between safeguarding properties promoting public health vital fostering innovation equitable ground-breaking technologies, underscoring significance addressing hurdles fully harness benefits vaccines enhancing healthcare outcomes a scale. STATEMENT OF SIGNIFICANCE: Several biomaterials proposed development nanovaccines, from polymeric micelles, PLGA-/PEI-/PLL-nanoparticles, solid lipid nananoparticles, cationic lipoplexes, liposomes, hybrid materials, dendrimers, carbon nanotubes, hydrogels, quantum dots. Lipid nanoparticles (LNPs) have gained tremendous attention since US Food Drug Administration (FDA) approval Pfizer Moderna's COVID-19 raising awareness vaccines. review provides insights into current strategies issues, clinical trials. By navigating landscapes we can unlock full using range promising towards improving worldwide.

Язык: Английский

---

Targeting tumor monocyte-intrinsic PD-L1 by rewiring STING signaling and enhancing STING agonist therapy

Cancer Cell, Год журнала: 2025, Номер 43(3), С. 503 - 518.e10

Опубликована: Март 1, 2025

Highlights•STING-induced PD-L1hi Tu.Mons dominate the resistance to STING agonist therapy•Cell-intrinsic PD-L1 induced by STING-IFN-I axis drives protumoral Tu.Mons•TLR2 activation rewires signaling reduce cell-intrinsic PD-L1•STING combined with TLR2 pre-activation shows enhanced antitumor efficacySummarySTING is an important DNA sensing machinery in initiating immune response, yet therapies targeting have shown poor outcomes clinical trials. Here, we reveal that induces tumor monocytes (Tu.Mons) against therapy. Cell-intrinsic PD-L1, STING-IRF3-IFN-I axis, identified as driving factor for Tu.Mons. Notably, TLR2-activated resist STING-induced upregulation of and associated functions. Mechanistically, stimulation remodels facilitating TRAF6 interaction, which suppresses IRF3-IFN-I response enhances NF-κB activation. Moreover, demonstrate combining agonists pretreatment significantly improves efficacy murine syngeneic humanized models. Our findings uncover a aspect mediated propose promising strategy boost immunity fine-tuning outputs.Graphical abstract

Язык: Английский

---

Exploring the immuno-nano nexus: A paradigm shift in tumor vaccines

Biomedicine & Pharmacotherapy, Год журнала: 2025, Номер 184, С. 117897 - 117897

Опубликована: Фев. 7, 2025

Язык: Английский

---

Autologous Nanovaccine Induces Immunogenic Domino Effect to Prevent Postoperative Recurrence of Orthotopic Glioblastoma

Advanced Functional Materials, Год журнала: 2025, Номер unknown

Опубликована: Фев. 3, 2025

Abstract Glioblastoma (GBM), the most aggressive form of primary intracranial tumors, poses significant challenges for effective treatment. The highly invasive characteristics GBM render complete tumor resection exceedingly difficult and frequently lead to postoperative recurrence. To address this issue, a novel autologous nano vaccine is developed convert immunosuppressive microenvironment into an active immune landscape through immunogenic domino effect, thereby targeting residual cells preventing This nanovaccine formulated by co‐loading lipopolysaccharide (LPS) glioblastoma cell lysates (GCL) layered double hydroxide (LDH) nanosheets, which are subsequently integrated within injectable alginate hydrogel create LLGA‐Gel. exploits potential GCL in conjunction with immunostimulatory properties LPS induce pyroptotic death, enhance dendritic maturation, promote macrophage polarization toward M1 phenotype; these effects culminate increased CD8 + T infiltration reduced Foxp3 Tregs at site. In vivo experiments demonstrate that not only enhances efficacy death but also significantly amplifies response, markedly reducing recurrence orthotopic GBM. study underscores promise nanotechnology‐enhanced immunotherapy developing nanovaccines against

Язык: Английский

---

Boosting Peroxidase-Mimetic Activity of FeMn-NC_e Dual-Atom Radiosensitizing Nanozymes for Augmented Radiodynamic Immunotherapy

ACS Nano, Год журнала: 2025, Номер unknown

Опубликована: Март 7, 2025

Dual-atom nanozymes (DAzymes) have garnered considerable attention as catalysts for reactive oxygen species (ROS)-based therapies, effectively leveraging ROS generation within the tumor microenvironment (TME). Herein, we introduce FeMn-NCe DAzymes, which are meticulously engineered enhanced peroxidase (POD)-mimetic activity and potent radiosensitization to advance radioimmunotherapy. Density functional theory (DFT) calculations reveal that DAzymes lower energy barrier increase substrate affinity, enabling highly efficient catalytic performance. Within TME, these efficiently convert overexpressed hydrogen peroxide (H2O2) into hydroxyl radicals (•OH), potentially activating cGAS-STING immune pathway. This POD-mimetic catalysis is further accelerated under X-ray irradiation, significantly enhancing radiosensitization. Additionally, a uniform coating of ultrasmall gold nanoparticles on enhances absorption cancer cells. The incorporation STING agonist diABZI onto induces long-term antitumor immunity, reprograms immunosuppressive suppresses growth metastasis following single low-dose treatment. work highlights valuable strategy designing radiodynamic immunotherapy.

Язык: Английский

---

Nanomaterials in gastric cancer: pioneering precision medicine for diagnosis, therapy, and prevention

Medical Oncology, Год журнала: 2025, Номер 42(4)

Опубликована: Март 6, 2025

Язык: Английский

---

STING Agonist Delivered by Neutrophil Membrane-Coated Gold Nanoparticles Exerts Synergistic Tumor Inhibition with Radiotherapy

ACS Applied Materials & Interfaces, Год журнала: 2024, Номер unknown

Опубликована: Сен. 24, 2024

Radiotherapy (RT) is one of the major treatments for cancers and a promising initiator immune response. Gold nanoparticles are radiosensitizer. In this study, we sought to optimize drug delivery efficiency gold explore their function in delivering stimulator interferon genes (STING) agonists with or without RT. covalent MSA-2 (MSA-Au) were mixed cRGD-modified neutrophil membranes obtain M-Au@RGD-NM. We explored treatment M-Au@RGD-NM combined Immune cell regulation STING pathway activation detected. successfully prepared significant tumor suppression by induction ROS resulting DNA damage.

Язык: Английский

---

Nanotechnology for boosting ovarian cancer immunotherapy

Journal of Ovarian Research, Год журнала: 2024, Номер 17(1)

Опубликована: Окт. 14, 2024

Ovarian cancer, often referred to as the "silent killer," is notoriously difficult detect in its early stages, leading a poor prognosis for many patients. Diagnosis delayed until cancer has advanced, primarily due ambiguous and frequently occurring clinical symptoms. leads more deaths than any other of female reproductive system. The main reasons high mortality rates include diagnosis resistance treatment. As result, there an urgent need improved diagnostic treatment options ovarian cancer. standard treatments typically involve debulking surgery along with platinum-based chemotherapies. Among patients advanced-stage who initially respond current therapies, 50-75% experience recurrence. Recently, immunotherapy-based approaches enhance body's immune response combat tumor growth have shown promise. Immune checkpoint inhibitors promising results treating types tumors. However, only few these been effective because tumor's environment suppresses system creates barriers This hampers effectiveness existing immunotherapies. Nonetheless, advanced immunotherapy techniques delivery systems based on nanotechnology hold promise overcoming challenges.

Язык: Английский

---

A VZV-gE subunit vaccine decorated with mPLA elicits protective cellular immmune responses against varicella-zoster virus

International Immunopharmacology, Год журнала: 2025, Номер 147, С. 114033 - 114033

Опубликована: Янв. 11, 2025

Язык: Английский

---

Recent Progress in Cancer Vaccines and Nanovaccines

Biomaterials, Год журнала: 2024, Номер 314, С. 122856 - 122856

Опубликована: Сен. 28, 2024

Язык: Английский

---