PVX108 / Aravax - LARVOL DELTA

New approaches in childhood IgE-mediated food allergy treatment. (PubMed, Curr Opin Allergy Clin Immunol) - "The portfolio of available treatment options for food allergies is increasing but several relevant unmet needs remain. This review aims to provide a brief overview of the existing and future treatment options for IgE-mediated food allergies."

Journal • Allergy • Food Hypersensitivity • Immunology • Transplantation

A Safety and Efficacy Study of PVX108 in Children and Adolescents with Peanut Allergy (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Aravax Pty Ltd | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Allergy • Food Hypersensitivity • Immunology

A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy (clinicaltrials.gov) - P2 | N=90 | Enrolling by invitation | Sponsor: Aravax Pty Ltd | Recruiting ➔ Enrolling by invitation | Trial completion date: Jul 2025 ➔ Jun 2027 | Trial primary completion date: Nov 2024 ➔ Nov 2025

Enrollment status • Trial completion date • Trial primary completion date • Allergy • Food Hypersensitivity • Immunology

Interim safety review of PVX108 peptide immunotherapy in an ongoing Phase 2 trial in peanut-allergic adolescents and children (EAACI 2024) - "Conclusion An interim review of safety data from an ongoing Phase 2 trial (AVX201) suggests PVX108 continues to be safe and well tolerated by peanut allergic adolescents. The DMC approved progression to cohort 2 to enrol peanut-allergic children aged 4-11 years."

Adverse events • Clinical • P2 data • Review • Allergy • Food Hypersensitivity • Immunology

Phase 1 trial supports safety and mechanism of action of peptide immunotherapy for peanut allergy. (PubMed, Allergy) - "This study supports the concept that PVX108 could provide a safe alternative to whole peanut immunotherapies and provides evidence of durable peanut-specific T-cell modulation. Translation of these findings to clinical efficacy in ongoing Phase 2 trials would provide important proof-of-concept for using peptides to treat food allergy."

Clinical • Journal • P1 data • Allergy • Food Hypersensitivity • Immunology • CCR6

PVX108 – A Peptide Immunotherapy for Peanut Allergy Safely Induces Durable Immune Changes in Peanut- Allergic Adults (EAACI 2023) - "Conclusion The observed combination of directional changes was consistent with the anticipated mechanism of action for PVX108 and has been associated with clinical benefit in other studies of specific immunotherapy for allergy (including peanut). These data demonstrate potential for PVX108 to safely induce long-lasting modulation of peanut-specific immune responses in peanut-allergic individuals."

Clinical • IO biomarker • Allergy • Food Hypersensitivity • Immunology • Inflammation • CCR6 • CD27 • CD4 • CD40LG • FOXP3 • IL2RA • ISG20 • TNFRSF9

A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Aravax Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Allergy • Food Hypersensitivity • Immunology

A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Aravax Pty Ltd

New P2 trial • Allergy • Food Hypersensitivity • Immunology

Aravax Pty Ltd announces opening of IND for Phase 2 clinical trials of PVX108, a next-generation immunotherapy for the treatment of peanut allergy (PRNewswire) - "Phase 2 study of PVX108 to commence in United States and Australia....Aravax...today announces that it has received a green light for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA)....The IND will allow Aravax to progress the Phase 2 clinical trial program into the U.S. and expand its global operations. 'We are excited to share that FDA has allowed Aravax to commence a Phase 2 efficacy study to identify the optimal dose of PVX108 in children with peanut allergy...'"

IND • New P2 trial • Food Hypersensitivity

Therapeutically relevant immunological changes observed following a phase 1 trialof PVX108 peptide-immunotherapy in peanut-allergic adults (EAACI 2021) - "We previously reported clear safety and tolerability of PVX108 in a phase I trial (AVX-001) in peanut allergic adults. These changes occurred without requirement for ongoing dosing and without inducing large IgE responses during treatment, as seen with whole allergen immunotherapy. These findings support the improved safety profile, proposed mechanism of action and progression of PVX108 into phase 2 clinical trials."

Clinical • IO biomarker • P1 data • Allergy • Food Hypersensitivity • Immunology • Inflammation • CD4 • CD40LG

[VIRTUAL] New treatments in food allergies (WAC 2020) - "Allergen-specific approaches -Epicutaneous immunotherapy-Sublingual immunotherapy-Subcutaneous immunotherapy with inactivated allergens -Recombinant protein vaccine (EMP-123)-Synthetic peptide vaccine (PVX-108)-DNA- LAMP vaccine (ASP0892)-High-affinity mAb specific for food allergens, e.g. Ara h 2. Among them, -Anti IgE (Omalizumab) alongside OIT-Omalizumab instead of OIT-Etokimab, directed against IL-33, a mediator necessary for sensitization to food allergens and allergic responses -Dupilumab, an antiIL-4/anti-IL-13 receptor alpha antibody already approved for the treatment of asthma and atopic dermatitis, alongside OIT. -Dupilumab alone -Anti-IL-5 antibodies mepolizimab and reslizumab, specifically in EoE."

Allergy • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Food Hypersensitivity • Immunology • Respiratory Diseases • IL13 • IL5