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Lipid Nanoparticle (LNP) news September 11-29, 2025

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News Summary

  • Nature Communications: Circular RNA-based protein replacement therapy mitigates osteoarthritis in male mice using LNPs prepared with NanoGenerator Flex-M.

  • ACS Nano: New manufacturing approach achieves precise size control for mRNA-loaded LNPs to improve reproducibility and performance.

  • Journal of Clinical Investigation: Allergen-specific mRNA–LNP therapy prevents and treats experimental allergy in mice.

  • Advanced Materials: Polyphenol-mediated engineering yields nonlamellar LNPs with cubic/hexagonal phases, expanding drug cargo options.

  • Moderna (CIDRAP): Updated 2025–26 Spikevax formulation shows strong immune response in adults, including older and at-risk groups.

  • Pfizer/BioNTech (CIDRAP): 2025–26 Comirnaty formulation shows strong phase 3 immunogenicity with at least 4-fold antibody rise.

  • GlobeNewswire/Towards Healthcare: Lipid nanoparticles market projected 13.97% CAGR to 2034, driven by biopharma R&D and targeted therapies.

  • CordenPharma: Hosts LNP Summit 2025 in Boston with focus on extrahepatic delivery, formulation, scale-up, and regulatory pathways.

  • Drug Target Review: Microneedle patch development for mRNA–LNP delivery highlights alternative administration routes.

  • Breakthrough Group: Analysis highlights Evonik–Ethris strategic partnership to expand RNA delivery with thermostable LNP platform coverage.


Detailed Summaries

circRNA protein replacement therapy for osteoarthritis

Fig 1. MSI2 is a potential target for osteoarthritis treatment.
Fig 1. MSI2 is a potential target for osteoarthritis treatment.

A Nature Communications study reports that circular RNA-based protein replacement therapy mitigates osteoarthritis in male mice, using LNPs prepared with the NanoGenerator Flex-M system to deliver therapeutic payloads to joints. The work underscores the stability and translational capacity of circRNAs within LNPs for durable protein expression in vivo.


Precise-size manufacturing of mRNA–LNPs

Fig 2. By decoupling particle design from mixing and formulation changes, this method enables the rational engineering of LNPs with defined properties. The method leverages mixing under high fusogenicity conditions, achieved by modulating the solvent composition, followed by timed postinjection of an aqueous buffer to kinetically arrest LNPs at the desired properties.
Fig 2. By decoupling particle design from mixing and formulation changes, this method enables the rational engineering of LNPs with defined properties. The method leverages mixing under high fusogenicity conditions, achieved by modulating the solvent composition, followed by timed postinjection of an aqueous buffer to kinetically arrest LNPs at the desired properties.

An ACS Nano paper details a manufacturing strategy that enables precise size control of mRNA-loaded LNPs, enhancing batch-to-batch reproducibility and performance for nucleic acid therapeutics. The study addresses a key translational bottleneck by controlling critical quality attributes linked to biodistribution and efficacy.

Allergen-specific mRNA–LNP therapy

Fig 3. Graphic abstract describes how a novel vaccine helped treat and prevent allergic reactions in mice.
Fig 3. Graphic abstract describes how a novel vaccine helped treat and prevent allergic reactions in mice.

The Journal of Clinical Investigation reports that an allergen-specific mRNA–LNP therapy both prevents and treats experimental allergy in mice, advancing LNP applications beyond vaccines toward immune tolerance. The findings suggest a platform path for prophylactic and therapeutic allergy interventions using LNP-delivered mRNA.

  • Release date: September 22, 2025

  • Authors: Yrina Rochman, Michael Kotliar, Andrea M. Klingler, et al.

  • Website link: https://www.jci.org/articles/view/194080

  • Related institute location: Cincinnati, Ohio, USA


Polyphenol-mediated nonlamellar LNPs

Self-assembly of TA/DMG-PEG PLC-LNPs. A) Schematic of the preparation of TA/DMG-PEG micellar cubosomes using a NanoAssemblr microfluidic device. B–E) Cryo-transmission electron microscopy images of DMG-PEG NPs (B) and TA/DMG-PEG micellar cubosomes assembled using different concentrations of TA and DMG-PEG (formulations are listed in Table S1, Supporting Information) C–E). Scale bars are 200 nm. Insets are fast Fourier transform images with assigned Miller indices for the section marked with a red frame (left) and 2D SAXS patterns of the samples (right). F–H) 1D SAXS patterns (F), size distribution (G), and ζ-potential (H) of DMG-PEG (0:1) and TA/DMG-PEG NPs assembled using increasing polyphenol (TA)-to-lipid (DMG-PEG) molar ratios from 0:1 to 10:1. The concentration of DMG-PEG used for LNP preparation was 2 mm. In (H), data are shown as mean ± standard deviation (SD) (n = 3 independent replicates).
Fig 4. Self-assembly of TA/DMG-PEG PLC-LNPs. (A) Schematic of the preparation of TA/DMG-PEG micellar cubosomes using a NanoAssemblr microfluidic device. (B–E) Cryo-transmission electron microscopy images of DMG-PEG NPs (B) and TA/DMG-PEG micellar cubosomes assembled using different concentrations of TA and DMG-PEG (formulations are listed in Table S1, Supporting Information) (C–E). Scale bars are 200 nm. Insets are fast Fourier transform images with assigned Miller indices for the section marked with a red frame (left) and 2D SAXS patterns of the samples (right). (F–H) 1D SAXS patterns (F), size distribution (G), and ζ-potential (H) of DMG-PEG (0:1) and TA/DMG-PEG NPs assembled using increasing polyphenol (TA)-to-lipid (DMG-PEG) molar ratios from 0:1 to 10:1. The concentration of DMG-PEG used for LNP preparation was 2 mm. In (H), data are shown as mean ± standard deviation (SD) (n = 3 independent replicates).

A study in Advanced Materials demonstrates polyphenol-mediated engineering of LNPs to form nonlamellar mesophases (cubic and hexagonal), increasing internal surface area and enabling diverse cargo loading. This structural tunability broadens LNP versatility for drugs, proteins, ions, and nucleic acids.

Updated Spikevax immunogenicity (CIDRAP)

Fig 5. Moderna Covid 19 Vaccine vial
Fig 5. Moderna Covid 19 Vaccine vial

CIDRAP reports Moderna’s preliminary immunogenicity data showing a strong antibody response for the 2025–26 updated Spikevax formulation, including older adults and those with risk conditions. The safety profile was consistent with earlier studies, with no new safety concerns identified.

Updated Comirnaty phase 3 (CIDRAP)

Fig 6. Pfizer Covid Vaccine Vials
Fig 6. Pfizer Covid Vaccine Vials

CIDRAP highlights Pfizer/BioNTech phase 3 data for the 2025–26 Comirnaty formulation, showing at least a 4-fold increase in neutralizing antibodies across older and at-risk adults. The safety profile was consistent with prior trials and no new safety issues were identified.

LNP growth to 2034

Fig 7. LNP Market Size Chart
Fig 7. LNP Market Size Chart

A GlobeNewswire release (Towards Healthcare) projects the LNP market will reach USD 3.84B by 2034, a 13.97% CAGR, driven by biopharma R&D and targeted therapies demand. The analysis cites North American leadership and rapid Asia-Pacific growth, with therapeutics as the dominant application segment.

CordenPharma LNP Summit 2025 (Boston)

CordenPharma’s LNP Summit (held Sep 9) published its recap during the window, highlighting talks on extrahepatic targeting, formulation/process scale-up, IP, and regulatory pathways for novel lipids. The Boston-based event convened industry and academic experts on xRNA and targeted nanoparticle drug delivery.

Microneedle patch for mRNA–LNPs

Fig 8. Development of a microneedle patch for delivery of mRNA-lipid nanoparticles
Fig 8. Development of a microneedle patch for delivery of mRNA-lipid nanoparticles

Drug Target Review covered the development of a microneedle patch for delivering mRNA–LNPs, underscoring alternative administration routes that could improve access and stability. The piece summarizes recent data on LNP composition effects when transitioning to microneedle formats.

Evonik–Ethris partnership

Breakthrough Group analyzed the Evonik–Ethris strategic partnership, emphasizing its implications for thermostable, inhalable LNP delivery platforms for respiratory medicine. Although the original deal was earlier in September, this analysis article was released within the specified window and captures its RNA-delivery impact.


 
 
 

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