Aravax's PVX108 Receives FDA Fast Track Designation for Peanut Allergy

The US Food and Drug Administration (FDA) has granted Fast Track designation to PVX108, Aravax's investigational peptide immunotherapy for peanut allergy, the company announced August 3, 2026.¹

PVX108 enters this pathway as a peptide-based immunotherapy distinct from oral immunotherapy products such as Palforzia, which was officially discontinued as of July 31, 2026.² PVX108 is designed to retrain immune tolerance without the acute allergic reactions associated with existing desensitization approaches.¹

“There remains a critical need for effective new treatments for food allergy, and we believe PVX108 has the potential to offer a safer, more convenient and disease-modifying treatment for the millions affected by peanut allergy worldwide," said Pascal Hickey, chief executive officer, Aravax.¹ "Receiving FDA Fast Track designation is a significant step for PVX108's future development as being able to communicate more frequently with the FDA often leads to early drug approval and access by patients."

PVX108 uses Aravax's proprietary peptide platform, engineered with 7 short synthetic fragments of the major peanut allergen. The product contains no whole allergens or extracts.³ The treatment is administered intradermally once per month and does not require dose escalation.

Early Data from the Phase 1 AVX-001 and AVX-001-EXT Trials

PVX108 safety and tolerability were evaluated in AVX-001, a randomized, double-blind, placebo-controlled phase 1 trial in 67 peanut-allergic adults.⁴ The trial comprised of a single ascending-dose stage (49 participants; 33 receiving PVX108 [doses 0.05 to 150 nmol]; 16 receiving placebo) and a repeat-dose stage (18 participants; 13 receiving 6 doses of 150 nmol over 16 weeks, 5 receiving placebo).¹ Preclinical basophil activation testing in 185 peanut-allergic donors showed negligible PVX108-induced activation compared with peanut extract, which reached 84% activation at the highest concentration tested.¹

Investigators reported no serious adverse events. The only adverse event occurring more frequently with PVX108 than placebo was mild injection site reaction, seen in 54.5% of active participants in the single ascending-dose stage and 84.6% in the repeat-dose stage, compared with 25% and 0% of placebo recipients, respectively.¹ Reactions were predominantly Grade 1 erythema and resolved without intervention.

Exploratory analyses in a subset of repeat-dose participants (n = 15) showed PVX108 shifted peanut-reactive Th-cell phenotype toward tolerance, with significant decreases in Th2A, Th2, and Th1 percentages and a significant increase in Th17 percentage by month 18 versus placebo (P =.031 for Th2A, P =.052 for Th17).¹ Regulatory T-cell frequency also rose significantly in the active group, alongside a subtle increase in peanut-specific IgG4 without change in IgE.¹ These shifts strengthened after treatment ended, unlike the plateau or reversal typically seen once oral or epicutaneous immunotherapy is stopped.¹

PVX108 Ongoing Phase 2 Trial Design

The designation arrives as Aravax's international phase 2 trial continues enrollment across the United States and Australia, with topline data expected later in 2026.¹ Aravax has not disclosed the trial's registered acronym, planned enrollment size, or specific dosing regimen in its Fast Track announcement. Topline data are anticipated later in 2026, according to the company.¹

References

1. Aravax. Aravax awarded FDA Fast Track designation for PVX108, a next-generation immunotherapy for the treatment of peanut allergy. Published August 3, 2026. Accessed August 4, 2026. https://www.biospace.com/press-releases/aravax-awarded-fda-fast-track-designation-for-pvx108-a-next-generation-immunotherapy-for-the-treatment-of-peanut-allergy

2. Wood and Ross. Palforzia Discontinued, Ending the Only FDA-Approved Peanut OIT Option. HCPLive. Published July 31, 2026. Accessed August 4, 2026. https://www.hcplive.com/view/palforzia-discontinued-ending-only-fda-approved-peanut-oit

3. PVX108 for Peanut Allergy. Aravax. Accessed August 4, 2026. https://www.aravax.com.au/programmes-and-clinical-trials/pvx108-for-peanut-allergy/

4. Voskamp AL, Khosa S, Phan T, et al. Phase 1 trial supports safety and mechanism of action of peptide immunotherapy for peanut allergy. Allergy. 2024;79(2):485-498. doi:10.1111/all.15966