Iambic Therapeutics Marks a Key Milestone in Advancing Cancer Treatment: IND Submission for IAM1363, a Selective, Brain-Penetrant HER2 Inhibitor

Potential best-in-class IAM1363 is the first candidate from Iambic’s AI-driven, physics-informed, discovery platform to reach Investigational New Drug (IND) submission. Phase 1 study of safety and tolerability is expected to begin dosing subjects in early 2024.
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December 22, 2023

SAN DIEGO, CA – Dec. 22, 2023 - Iambic Therapeutics, a biotechnology company developing novel therapeutics using its unique generative AI discovery platform, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical study evaluating IAM1363, a selective and brain-penetrant inhibitor of HER2 signaling for the treatment of HER2-driven solid tumors.

“As the first asset from our AI-driven platform to advance to the clinical stage, IAM1363 examplifies how physics-informed generative AI and a world-class discovery team can identify highly differentiated drug candidates in an accelerated time frame. Based on preclinical findings, including data presented at AACR 2023, we expect IAM1363 to demonstrate best-in-class properties within the HER2 inhibitor class. In particular, it holds the potential to effectively target tumors that have metastasized to challenging anatomic sites, such as the brain.”
- Tom Miller, Ph.D., Co-Founder and Chief Executive Officer of Iambic Therapeutics.

“While HER2 inhibition is an essential approach in cancer treatment and represents a well-established mechanism of action, off-target toxicities and narrow therapeutic window are serious limitations for the existing therapeutics in this class,” remarked Chao Zhang, Ph.D., Chief Scientific Officer of Iambic Therapeutics. “In preclinical studies, IAM1363 has demonstrated favorable efficacy and tolerability across various HER2 tumor models, including intracranial models, while sidestepping EGFR-associated toxicity. Given the significant challenge of metastatic spread to the brain in patients with HER2-driven cancers, we look forward to establishing the clinical benefit of this candidate and working to bring this treatment to patients.”

In the planned multiple-center Phase 1 study, Iambic Therapeutics aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IAM1363 in patients with HER2-associated malignancies.

IAM1363 (previously designated IAM-H1 and ENT-H1) is a selective and brain-penetrant small molecule inhibitor of HER2 wildtype and oncogenic mutant proteins, designed to expand therapeutic index compared to available HER2 inhibitors and to avoid toxicities from off-target inhibition of EGFR, a related receptor tyrosine kinase. In preclinical studies, IAM1363 has demonstrated over 1000-fold selectivity for HER2 compared to EGFR, a promising pharmacokinetic and safety profile, preferential tumor enrichment, and penetrance of the central nervous system. In HER2 tumor models, including intracranial tumor models, IAM1363 has demonstrated favorable efficacy and tolerability compared to benchmark tyrosine kinase inhibitors and HER2-targeted antibody-drug conjugates. IAM1363 was identified using Iambic Therapeutics’ AI-driven discovery platform, which unifies physics-informed machine learning and experimental automation to identify therapeutic candidates with differentiated drug profiles.

About Iambic Therapeutics

Founded in 2019 and headquartered in La Jolla, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinical stage with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs. Learn more about the Iambic team, platform, and pipeline at iambic.ai.


Mary Anderson


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