Mabylon Initiates First-in-Human Trial of Novel Tri-Specific Antibody MY006 for Peanut Allergy Prevention
核心洞察
Mabylon AG (搜索) has dosed the first participant in a Phase I clinical trial evaluating MY006, a novel tri-specific monoclonal antibody designed for prophylactic treatment of peanut allergy (搜索).
MY006 is a human-derived antibody that binds to three major peanut allergens (搜索) simultaneously, potentially offering superior protection compared to mono-specific antibodies with only 2-4 annual injections.
The randomized, quadruple-blinded Phase 1a/b trial will enroll up to 48 participants across healthy volunteers and peanut-allergic patients to assess safety, tolerability, and pharmacokinetics.
Mabylon AG (搜索) has achieved a significant milestone by dosing the first participant in a first-in-human clinical trial evaluating MY006, a novel tri-specific monoclonal antibody designed for the prophylactic treatment of peanut allergy (搜索). The Swiss biotechnology company announced that the first healthy volunteer received the experimental therapy as part of a comprehensive Phase 1a/b study aimed at addressing one of the most common and potentially lethal food allergies.
Novel Tri-Specific Antibody Design
MY006 represents a breakthrough in antibody engineering for allergy treatment. According to Dr. Niccolò Pengo, Chief Scientific Officer of Mabylon, "MY006 is a human-derived monoclonal antibody with high-affinity binding to the three major peanut allergens (搜索)." The tri-specific format enables simultaneous recognition of non-overlapping epitopes across multiple allergens, which enhances broad neutralization compared to mono-specific antibodies.
The antibody has been engineered for sustained serum levels, high stability, and continuous protection with infrequent dosing, requiring only 2 to 4 subcutaneous injections annually. This dosing schedule addresses significant limitations of current allergy therapies that require frequent administration.
Clinical Trial Design and Objectives
The ongoing study is structured as a randomized, quadruple-blinded, placebo-controlled, single-ascending, and multiple-dose Phase 1a/b clinical trial. The study will assess the safety, local tolerability, pharmacokinetics, and immunogenicity of MY006 while exploring pharmacodynamics and clinical activity in patients.
Part A of the trial will enroll up to 32 healthy adult volunteers aged 18-55 years across up to four cohorts to assess increasing single doses of MY006 via subcutaneous injection, followed by a multiple-dose cohort at the highest tolerated dose. Part B will enroll up to 16 adolescent and adult peanut-allergic patients aged 12-55 years. The trial is being conducted at one early-phase clinical unit for Part A and several specialized allergy/immunology sites across the United States for Part B.
Addressing Significant Medical Need
Peanut allergy (搜索) affects approximately 1-2% of the population in the United States and Europe, representing a significant unmet medical need. MY006 is designed as a prophylactic therapy to prevent allergic reactions (搜索) and anaphylactic shock (搜索), potentially offering protection against accidental peanut exposure.
"By dosing the first participant, we are one step closer to potentially delivering a prophylactic therapy that could safeguard patients from the risks of accidental peanut exposure," said Peter Lichtlen, Chief Medical Advisor of the Company.
Company Milestone and Future Outlook
The initiation of this clinical trial marks Mabylon's transition to a clinical-stage company. Dr. Alcide Barberis, Chief Executive Officer of Mabylon AG (搜索), emphasized the significance of this achievement: "The initiation of this clinical trial is an important milestone and a significant advancement of our efforts to address the unmet needs in peanut allergy (搜索) management through innovative antibody engineering. We are very pleased about the positive IND review by the FDA and proud of becoming a clinical-stage company."
Mabylon specializes in harnessing the therapeutic potential of naturally occurring human antibodies to treat allergies, neurodegenerative diseases, and inflammation. The company's approach utilizes human-derived antibodies, which have superior therapeutic potential compared to antibodies derived from conventional sources such as humanized animal models or artificial libraries. In allergy treatment, Mabylon's antibodies derived from allergic patients target disease-relevant epitopes, expanding knowledge of novel allergenic epitopes and their role in disease progression.