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Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
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Area of Science:

  • Biotechnology
  • Immunology
  • Oncology

Background:

  • Lipid nanoparticle (LNP)-encapsulated mRNA technology has advanced in vivo protein production for vaccines and therapeutics.
  • Delivering complex, multispecific biologics with higher-order structures is crucial for expanding mRNA/LNP applications.
  • Previous studies focused on simpler secreted proteins like IgG.

Purpose of the Study:

  • To evaluate the feasibility of using mRNA/LNP formulations for in vivo production of complex, oligomeric fusion proteins (SIRPα-Fc-CD40L and TIGIT-Fc-LIGHT).
  • To assess if these mRNA/LNP formulations achieve functional oligomerization, extended exposure, and potent antitumor activity comparable to recombinant proteins.

Main Methods:

  • Administered intravenous mRNA/LNP formulations encoding SIRPα-Fc-CD40L and TIGIT-Fc-LIGHT.
  • Measured in vivo protein production, oligomerization, pharmacokinetics, and biodistribution.
  • Assessed immune cell infiltration (CD8+ T cells), cytokine levels (IL2), tumor growth, survival, and combination therapy efficacy with anti-PD-L1.

Main Results:

  • Achieved rapid and sustained in vivo production of functional hexameric fusion proteins.
  • Demonstrated significantly increased protein exposure (28-140 fold) and tumor concentrations (up to 134-fold) compared to recombinant proteins.
  • Observed enhanced CD8+ T cell infiltration in tumors, increased IL2 levels, delayed tumor growth, and extended survival.
  • Showed improved efficacy in combination with anti-PD-L1 therapy.

Conclusions:

  • mRNA/LNP formulations can successfully deliver complex, oligomeric biologics for in vivo production.
  • This approach leads to superior therapeutic protein exposure, on-target activity, and antitumor immune responses.
  • mRNA/LNP delivery of complex biologics holds potential for improved patient outcomes in oncology.