Introduction
Current allergen products carry significant limits in terms of their quality and consistency and this likely accounts for their shortcomings in the clinical diagnosis of allergy and its treatment through desensitization. Increasingly, stakeholders (clinicians, the pharmaceutical industry and regulatory agencies) are seeking better, more effective products aligned with the principles of Precision Medicine.
Method
A specific plant-based biotechnology was developed to produce high-quality (“natural-like”) allergens for in vivo diagnostic at the point of care. A synthetic biology approach was then used for the design and in vivo production of therapeutic products complementary to their diagnostic counterpart under the form of allergen-bearing bioparticles. This biosynthetic approach is completely modular, and the resulting bioparticles can bear any target allergen on their surface. As for true VLPs (virus-like particles), the immunomodulation potency of these particle results from both the presence of specific components within the particle core, from the size of the bioparticle and from the repetitive pattern of allergen presentation on its surface.
Results
This novel one-step production platform provides levels of efficacy, safety, scalability and cost-efficiency for the production of pure diagnostic allergens that are inaccessible to current extraction approaches. For both the diagnostic allergens and the corresponding therapeutic bioparticle-based allergen products, the production platform is GMP compatible and makes for consistency in product quality / batch to batch reproducibility that has so far remained elusive. Of much greater importance and potential clinical impact are the results obtained from pre-clinical studies. Our recent immunogenicity studies demonstrate that administration of this new generation of allergen bioparticles triggers a strong and specific Th1-biased immune response and does not cause allergy-related manifestations. In vitro / ex vivo studies have also demonstrated that allergen bioparticles do not cause degranulation in sera of human allergic patients. Recent results obtained from these studies and more recent data on prophylaxis will be presented and discussed.
Conclusion
This new approach to the production of allergen product for the diagnosis and treatment of allergy could bring a generational change in our fight of allergy. With sophisticated and convivial products able define to more closely one’s molecular / component allergy diagnosis at the point of care, and with potent yet safe therapeutic products closely tailored to such results, immunotherapy delivered through therapeutic vaccination could thrust Precision Medicine at the center of allergy management.
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