Iambic Initiates Phase 1 Trial of HER2 Inhibitor IAM1363 for Solid Tumor Treatment

Iambic Therapeutics, a biotech company utilizing an AI-driven discovery platform to create innovative therapeutics, has dosed the first patient in a Phase 1 clinical trial for IAM1363. This compound is a selective inhibitor of HER2 signaling, designed to treat cancers driven by HER2 alterations.
IAM1363 is the first program from Iambic's AI platform to transition into human studies. The drug candidate is highly selective for HER2 inhibition, with over 1000-fold greater selectivity for HER2 compared to EGFR, potentially minimizing toxic side effects associated with off-target inhibition. Preclinical studies have shown IAM1363's ability to penetrate the central nervous system and its efficacy in HER2 tumor models, including those with brain metastases.
The Phase 1/1b trial, registered as NCT06253871, is an open-label, multi-center study aimed at assessing the tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IAM1363 as a monotherapy and in combination with trastuzumab for patients with advanced HER2 cancers.
Iambic's AI-driven discovery platform integrates physics-informed machine learning with experimental automation to identify therapeutic candidates with unique drug profiles. The company's goal is to rapidly advance high-quality, differentiated therapeutics from preclinical to clinical stages across various target classes and mechanisms of action.
Dr. Alexander Spira, principal investigator for the IAM1363 Phase 1 study, highlighted the need for improved therapies for HER2-driven cancers, especially for patients with brain metastases. He expressed optimism in IAM1363's potential to offer a promising treatment option due to its potency, selectivity, and ability to cross the blood-brain barrier.
Iambic Therapeutics, established in 2019 and based in San Diego, California, is dedicated to addressing urgent unmet patient needs with its cutting-edge AI-driven drug-discovery platform. The company's internal pipeline focuses on clinical assets for various diseases.

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