Iambic Therapeutics, a clinical-stage life science and technology company developing novel medicines using its AI-driven discovery and development platform, announced it has entered into a research collaboration and drug supply agreement with Jazz Pharmaceuticals. Under the agreement, Jazz will provide zanidatamab (Ziihera®), a HER2-targeted bispecific antibody, at no cost to Iambic for evaluation in combination with IAM1363, Iambic’s brain-penetrant HER2 small-molecule tyrosine kinase inhibitor (TKI). The combination will be studied in patients with HER2-positive breast cancer that have previously been treated with trastuzumab deruxtecan (T-DXd; Enhertu®).
"We are enthusiastic to pair our potential best-in-class HER2 TKI, IAM1363, with zanidatamab, the leading HER2-targeted bispecific antibody," said Neil Josephson, M.D., Chief Medical Officer of Iambic. "Together, these agents represent a powerful new strategy with the potential to transform treatment for patients with advanced HER2-positive breast cancer whose disease has progressed following first- or second-line treatment."
As part of the Phase 1/1b IAM1363-01 study, Iambic will initiate a cohort in patients with HER2-positive breast cancer to evaluate IAM1363 in combination with zanidatamab and capecitabine.
Alongside the research collaboration announcement, Iambic has reported clinical data for IAM1363 monotherapy at the European Society of Medical Oncology (ESMO) annual meeting in Berlin, showing anti-tumor activity, safety, and tolerability. The IAM1363 clinical data show activity in patients with HER2-mutant NSCLC and HER2-positive breast and gastric cancers, as well as indications lacking approved HER2-directed TKIs or antibodies, such as HER2-mutant renal cell cancer and HER2-amplified NSCLC and ovarian cancer. IAM1363 was specifically engineered to overcome the limitations of current HER2-directed therapies, demonstrating >5,000-fold selectivity for HER2 over EGFR, ten-fold greater CNS penetration than approved TKIs, and broad activity against both wild-type and mutant HER2.
Iambic’s Phase 1/1b trial, NCT06253871, is an open-label, multi-center, dose escalation and dose optimization study, designed to evaluate tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of IAM1363 in patients with advanced HER2 cancers. The study, which has multiple sites in the U.S., recently opened in the EU and will continue to expand into additional sites across the U.S. and EU and into the UK and APAC in Q4 2025.
About Iambic
Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at Iambic.ai
About Iambic’s AI-Driven Discovery Platform
The Iambic AI-driven platform was created to address the most challenging design problems in drug discovery, leveraging technology innovations such as Enchant (multimodal transformer model that predicts clinical and preclinical endpoints) and NeuralPLexer (best-in-class predictor of protein and protein-ligand structures). The integration of physics principles into the platform’s AI architectures improves data efficiency and allows molecular models to venture widely across the space of possible chemical structures. The platform enables identification of novel chemical modalities for engaging difficult-to-address biological targets, discovery of defined product profiles that optimize therapeutic window, and multiparameter optimization for highly differentiated development candidates. Through close integration of AI-generated molecular designs with automated chemical synthesis and experimental execution, Iambic completes design-make-test cycles on a weekly cadence.
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