Iambic’s AI-Designed HER2 Inhibitor IAM1363 Shows Early Anti-Tumor Activity in Heavily Pretreated Patients

IAM1363, a brain-penetrant, highly selective type-2 HER2 tyrosine kinase inhibitor, demonstrated anti-tumor activity in heavily pretreated patients with HER2-altered cancers, including those previously treated with T-DXd and tucatinib15.

The drug showed clinical activity across both HER2-wild-type and HER2-mutant tumors, with partial responses in 28% of patients with measurable systemic disease and 33% of those with measurable intracranial tumors5.

IAM1363 was developed using Iambic’s AI-driven platform, advancing from discovery to first-in-human dosing in under two years—significantly faster than conventional drug development timelines (typically six years)145.

The ongoing Phase 1/1b trial (NCT06253871) is evaluating safety, pharmacokinetics, and preliminary efficacy in patients with advanced HER2 cancers, with plans to expand into the EU, UK, and APAC in late 202514.

IAM1363 is over 5,000-fold more selective for HER2 than EGFR, aiming to reduce off-target toxicity and address resistance mechanisms, including in brain metastases—a major cause of morbidity in HER2-driven cancers45.

Iambic is exploring both monotherapy and combination therapy (with trastuzumab), with additional preclinical data to be presented at upcoming scientific meetings14.

Sources:

1. https://www.iambic.ai/post/esmo-iam1363

4. https://www.genengnews.com/topics/artificial-intelligence/iambic-rhythm-ai-drug-developer-enters-the-clinic-targeting-her2-cancers/

5. https://www.biopharmatrend.com/news/iambic-reports-early-clinical-activity-of-ai-designed-her2-inhibitor-1418/