Peanut Allergen (AraH2)

AYA22AR321

Neutralizing the Allergen at Its Source – Not Suppressing the Immune System

Peanut Allergen (AraH2)

AYA22AR321

Neutralizing the Allergen at Its Source – Not Suppressing the Immune System

AYA22AR321 is a DNA aptamer that directly binds and neutralizes the three major peanut allergens with sub-nanomolar to nanomolar affinity.
It reduces IgE-mediated allergic responses, modulates Th1/Th2 immune balance, and has been formulated as FISTOQ – an allergen-neutralizing surface spray with a complete published safety profile.

Binds Ara h1 (Kd 0.5 nM), Ara h2 (Kd 14.5 nM), and crude peanut extract (Kd 6.6 nM). Stops the allergic cascade at its molecular source.

Non-immunogenic, non-cytotoxic (human PBMCs), non-mutagenic (Ames test). Ready for regulatory advancement.

Therapeutic candidate for allergic response modulation AND FISTOQ surface decontamination product for food safety – a near-term commercial opportunity.

Peanut allergy affects approximately 2% of children worldwide and is the leading cause of food-induced anaphylaxis. The condition carries a significant psychological burden for patients and families, with constant vigilance required to avoid accidental exposure.

Current Treatment Limitations:

  • Palforzia (oral immunotherapy): Requires years of graduated allergen exposure, carries reaction risk at every dose, and does not provide complete protection. Many patients discontinue due to side effects.
  • Omalizumab (anti-IgE biologic): Treats the downstream immune response rather than addressing the allergen itself. Requires ongoing injections and costs $15,000–$30,000+ per year.
  • Avoidance: The primary strategy remains avoiding peanuts entirely — but accidental exposure in food processing, restaurants, and shared environments remains a constant, uncontrolled risk.

Neither current therapeutic approach neutralizes the allergen itself. And no existing product addresses the environmental exposure risk in food processing and consumer settings.

AYA22AR321 was designed using our computational biology platform and selected through in vitro screening to directly bind and neutralize the proteins responsible for peanut allergic reactions.

Binding Affinity:

  • Ara h1: Kd 0.5 nM (sub-nanomolar — exceptionally tight binding)
  • Ara h2: Kd 14.5 nM
  • Crude peanut extract: Kd 6.6 nM

Functional Mechanism:

By binding the major allergenic proteins, AYA22AR321 prevents IgE crosslinking on mast cells and basophils – the critical first step in the allergic cascade. When IgE cannot crosslink, mast cells do not degranulate, and the allergic reaction does not proceed. This was confirmed in RBL-2H3 cells (rat basophilic leukemia cell line) where AYA22AR321 significantly reduced IgE-mediated degranulation.

The aptamers also demonstrated effectiveness in neutralizing allergens in raw peanut seeds and commercial peanut products, confirming activity in real-world food matrices.

In vitro studies revealed that AYA22A aptamers (AYA22AR321, AYA22AR211, AYA22AR524) do more than simply bind allergens. They actively influence the Th1/Th2 cytokine balance:

  • Impact on immune cell expression and cytokine production resembles responses observed with established immunotherapies.
  • Suggests a role in genuine immune modulation – shifting the immune response away from the Th2-dominant allergic phenotype toward a more balanced Th1/Th2 profile.

This dual mechanism — direct allergen neutralization combined with immune modulation – positions AYA22AR321 as potentially more than a symptomatic treatment. It may represent a pathway toward genuine immune tolerance, a goal that current therapies have not achieved.

A comprehensive safety assessment of AYA22AR321 has been completed and published, providing a significant regulatory asset:

  • Non-Immunogenic: No immune activation detected in human PBMCs. Critical for a therapy targeting a population already prone to immune overreaction.
  • Non-Cytotoxic: Human PBMC viability fully maintained at therapeutic concentrations.
  • Non-Mutagenic: Ames test negative — no mutagenic potential detected.

This complete safety trifecta (non-immunogenic, non-cytotoxic, non-mutagenic) clears a major regulatory hurdle and differentiates AYA22AR321 from therapeutic approaches that carry inherent immune activation risks.

A Near-Term Commercial Product:

AYA22AR321 has been formulated as FISTOQ, an allergen-neutralizing surface spray designed for food processing environments, restaurants, schools, and consumer use.

Published Performance:

  • Effectively neutralized peanut allergens on peanut-butter-contaminated surfaces.
  • Eco-friendly formulation containing surfactant and preservative.
  • Confirmed stability: allergen-neutralizing efficacy maintained over time.

Commercial Significance:

FISTOQ represents a near-term revenue opportunity independent of the therapeutic development timeline. While the therapeutic aptamer continues through in vivo studies and toward clinical development, FISTOQ can enter the food safety market as a consumer and industrial product. This dual-path strategy – therapeutic + commercial product – is unique in the Ayass pipeline and reduces investor risk by providing a shorter path to market.

Current Stage: Late Lead Optimization — completing In Vivo Validations.

Completed: In silico design, binding characterization (3 allergens), degranulation assays, immune modulation profiling, comprehensive safety assessment, FISTOQ formulation and stability testing.

Two Development Paths:

  • Therapeutic Path: Further animal model studies for immune modulation, allergy prevention, and dose optimization. Progression toward IND-enabling studies.
  • Commercial Path: FISTOQ product development for food processing facilities, restaurants, schools, airlines, and direct consumer markets.

Aptamer-Enhanced Surface Decontamination: A Novel Approach for Neutralizing Peanut Allergens and Preventing Cell-Degranulation (MDPI).

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AYA22A Aptamers Mitigate Peanut Allergenicity: Insights from Degranulation Assays and Modulating Immune Responses

Dual partnership opportunity: therapeutic co-development with allergy research centers and pediatric immunology groups, plus commercial licensing or partnership for FISTOQ product launch in the food safety market. Contact us to discuss either or both opportunities.