Meiji Seika Pharma Begins Phase I Trial of PD-1 Agonist Antibody for Autoimmune Diseases

Japanese pharmaceutical company Meiji Seika Pharma Co., Ltd. has initiated a Phase I clinical trial of its experimental therapy ME3241, a novel anti-PD-1 agonist monoclonal antibody designed to treat autoimmune and inflammatory diseases.

The therapy was discovered through collaborative research with the Foundation for Biomedical Research and Innovation at Kobe, marking an important step toward developing new treatments for immune-related disorders.

Phase I Trial to Evaluate Safety and Tolerability

The Phase I study is designed as a randomized, placebo-controlled, double-blind clinical trial.

Researchers will evaluate:

• Safety and tolerability of ME3241
• Effects of single and multiple dosing
• Pharmacokinetics (how the drug moves through the body)
• Pharmacodynamics (how the drug affects the body)

The goal is to determine whether the therapy can safely advance into later-stage clinical development.

A New Approach to Treating Autoimmune Disease

ME3241 targets Programmed Cell Death Protein 1, commonly known as PD-1.

PD-1 is a receptor found on activated T cells and other lymphocytes, where it plays a key role in regulating immune responses.

Unlike most existing PD-1 therapies used in cancer treatment, which block PD-1 to activate the immune system, ME3241 works in the opposite way.

The therapy stimulates PD-1, enhancing its immunosuppressive activity.
This approach could help control overactive immune responses, which are a major cause of autoimmune diseases.

Discovery Led by Nobel Laureate Tasuku Honjo

The research behind ME3241 was led by Tasuku Honjo, a professor emeritus at Kyoto University and programme director at the Kobe research institute.

His team identified conditions that enable antibodies to activate PD-1 and induce immunosuppression.

These findings were published in Science Immunology in January 2023. According to Honjo, the therapy represents a significant shift from traditional PD-1 strategies.

Cancer immunotherapies typically use PD-1 antagonist antibodies to boost immune activity.
ME3241 instead uses a PD-1 agonist, which may help suppress harmful immune responses in inflammatory diseases.

Potential Applications in Inflammatory Disorders

Because ME3241 can dampen immune activity, researchers believe it could be useful for treating autoimmune diseases driven by excessive immune responses.

If successful, the therapy could offer new options for conditions where immune regulation is critical.

Preclinical studies in animal models demonstrated strong immunosuppressive activity, supporting advancement to human trials.

Path Toward Later-Stage Clinical Development

The ongoing Phase I trial represents the first step in evaluating ME3241 in humans.

If the study confirms an acceptable safety profile, the development pathway may include:

• Phase II trials to evaluate clinical efficacy
• Phase III trials to confirm safety and therapeutic benefit

The long-term goal is to bring the therapy into routine clinical use.

Strengthening Japan’s Biomedical Innovation Ecosystem

The program is also closely linked to the Kobe Biomedical Innovation Cluster, an initiative aimed at accelerating translational research in Japan.

According to Honjo, advancing ME3241 into clinical trials marks a milestone in translating basic immunology research into therapeutic applications.

Expanding Meiji Seika Pharma’s Immunology Pipeline

For Meiji Seika Pharma Co., Ltd., the program aligns with the company’s broader research focus on infectious and immune-related diseases.

The company plans to continue collaborating with the Foundation for Biomedical Research and Innovation at Kobe to accelerate development.

By advancing ME3241, the partners aim to deliver a new class of immunomodulatory therapy to patients with autoimmune diseases as quickly as possible.

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