Mabylon Advances MY006 Peanut Allergy Treatment to Phase Ib Following Positive Safety Data
核心洞察
Mabylon AG (搜索) reported positive Phase Ia safety data for MY006, a multi-specific antibody treatment for peanut allergy (搜索), with no treatment-related serious adverse events observed in healthy volunteers.
The Safety Monitoring Committee recommended initiation of Phase Ib dosing in peanut-allergic patients based on favorable safety profile and pharmacokinetic data showing linear dose proportionality and extended half-life.
The company also advanced its MY010 tree pollen allergy (搜索) program into GMP manufacturing for toxicology studies, targeting birch, oak, hazel, and alder allergens (搜索).
Swiss biotechnology company Mabylon AG (搜索) has reported positive preliminary Phase Ia safety data for its lead peanut allergy (搜索) treatment MY006 and initiated dosing in peanut-allergic patients as part of the Phase Ib portion of its ongoing first-in-human trial. The Safety Monitoring Committee recommended advancing to the patient cohort based on favorable safety and pharmacokinetic profiles observed in healthy volunteers.
Phase Ia Safety Results Support Clinical Advancement
The randomized, quadruple-blinded, placebo-controlled Phase Ia/Ib study evaluates safety, tolerability, pharmacokinetics, immunogenicity, and preliminary clinical activity of MY006 in healthy volunteers and peanut-allergic adolescents and adults. As of the end of April 2026, dosing of healthy volunteers in Part A has been completed for all subjects.
Preliminary blinded data indicate MY006 has been well tolerated to date, with no treatment-related serious adverse events or adverse events of severe intensity reported. The blinded pharmacokinetic profile closely matches Mabylon's preliminary PK model and demonstrates linear dose proportionality as well as an extended half-life, supporting further clinical development.
"The preliminary safety and PK profiles observed so far support our confidence in the potential of MY006 as a differentiated prophylactic approach for peanut allergy (搜索)," said Dr. Niccolò Pengo, Chief Scientific Officer of Mabylon.
Phase Ib Explores Clinical Activity in Patients
Based on the available safety and pharmacokinetic data, the study's Safety Monitoring Committee recommended initiation of Part B of the trial. Part B is conducted in peanut-allergic patients, with first patients entering screening in early May 2026. This portion of the study is designed to explore early signals of clinical activity and desensitization potential using double-blinded, placebo-controlled food challenges at different timepoints following MY006 administration.
MY006 is a subcutaneous multi-specific antibody treatment designed to address peanut allergy (搜索), described as one of the most severe and potentially life-threatening food allergies worldwide with high unmet medical need. The compound is based on patient-derived antibodies and is designed to prevent allergic reactions, including anaphylaxis (搜索), in individuals with peanut allergy with only a few subcutaneous injections per year.
Pipeline Expansion with Tree Pollen Program
Mabylon also announced progress with its second development program, MY010, targeting allergies to tree pollen of the Fagales order. The multi-specific antibody is designed to neutralize birch pollen allergens (搜索) as well as closely related, clinically relevant tree pollen allergens from oak, hazel, alder, and other Fagales species.
The MY010 program recently completed cell line development and has entered GMP manufacturing in preparation for GLP toxicology studies, IND filing, and subsequent clinical development. The company is establishing a dedicated Clinical Development Advisory Board for MY010, bringing together leading experts in the allergy and immunology field.
Platform Strategy and Funding
"Our goal is to build a leading antibody-based allergy therapeutics pipeline with multiple differentiated product candidates addressing severe allergic diseases," said Dr. Alcide Barberis, Chief Executive Officer of Mabylon AG (搜索). "Our multi-specific drug candidates are designed to neutralize several key allergens simultaneously, potentially enabling broad allergen protection with only a few administrations per year."
In addition to CHF 30 million capital raised in 2025, the company has secured necessary funding to advance both MY006 and MY010 through the next stages of clinical development. Mabylon's approach utilizes human-derived antibodies, which the company states have superior therapeutic potential compared to antibodies derived from conventional sources such as humanized animal models or artificial libraries.