#Japan #Tokyo #CAR-T therapy #Noile Immune #NIB103

Noile Immuno Biotech Submits NIB103 Clinical Trial Plan

Noile Immuno Biotech Co., Ltd. (Minato, Tokyo, CEO Koji Tamada), a firm dedicated to the development of CAR-T cell therapies for solid tumors, has successfully submitted the clinical trial plan for their priority pipeline NIB103 to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. This submission marks a significant step forward for the company as it seeks to address unmet medical needs in the treatment of solid tumors.

The clinical trial, designated as a Phase I study, focuses on patients who exhibit advanced or metastatic solid tumors with mesothelin expression, and for whom standard treatment options are either unrecognized or intolerable. Through this trial, Noile Immuno aims to evaluate the safety and tolerability of NIB103, with additional focus on anti-tumor effects and cellular kinetics. The company is planning to include 12 to 30 cases in this study, ensuring a thorough assessment of the investigational therapy.

Originally, NIB103 was being developed by Takeda Pharmaceutical Company. However, the rights to further develop and commercialize the product were returned to Noile Immuno, following Takeda's strategic decision concerning its pipeline. Recognizing the potential of NIB103, Noile Immuno selected it as a priority and engaged in extensive discussions with leading clinical researchers to prepare for the trial.

In September 2024, Noile Immuno established a collaborative agreement with Takara Bio for the joint development of NIB103 in Japan. This partnership is crucial for maintaining an efficient manufacturing setup for the drug within the country, thereby enhancing Noile Immuno's operational capabilities as it embarks on this clinical journey.

The initiation of this trial is anticipated to pave the way for essential further clinical studies based on the outcomes of the Phase I trial. As Noile Immuno moves forward, they remain committed to reshaping cancer treatment through their innovative PRIME technology, which enhances the efficacy of immune cell therapies.

Despite the promising direction of the trial, the company estimates that the impact of this initiative on their fiscal performance for the period ending December 2025 will be minimal. They assure stakeholders that any significant developments will be communicated promptly.

As a biotech firm stemming from academia, Noile Immuno is dedicated to the commercialization of next-generation cancer immunotherapies through its proprietary PRIME technology, which allows for the creation of novel pharmaceuticals through innovative combinations of various chimeric antigen receptors (CARs). This adaptability places Noile Immuno at the forefront of emerging cancer treatment strategies.

To learn more about Noile Immuno and its pioneering research efforts, visit Noile Immuno Biotech's official website.