On October 5, 2026 Iambic Therapeutics, Inc. (Iambic), a clinical-stage life science and technology company developing novel medicines using its AI-driven platform, reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2 clinical trial evaluating IAM217, a brain-penetrant, differentiated inhibitor of KIF18A for the potential treatment of triple-negative breast cancer, ovarian cancer, and other solid tumor indications with chromosomal instability (CIN). In a preclinical brain metastasis model, IAM217 produced approximately 90% regression of established intracranial tumors.
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"Iambic’s mission is to make better technology for better medicines, and today marks another important milestone for the company," said Tom Miller, PhD, Co-Founder and CEO, Iambic. "With IAM217 poised to enter clinical trials, IAM1363 well underway in clinical trials, and our CDK2/4 dual inhibitor program advancing toward IND submission, we believe that we are seeing meaningful productivity from our molecular superintelligence platform."
KIF18A is a mitotic motor protein (kinesin) that governs chromosome alignment during cell division. Cancer cells with CIN — a hallmark of many of the most aggressive and treatment-refractory cancers — depend on KIF18A to complete cell division, while normal cells tolerate its inhibition, creating a potential therapeutic window distinct from broadly cytotoxic antimitotic agents. There is emerging clinical evidence that potentially validates KIF18A as an important target for high-grade serous ovarian cancer and preclinical evidence for a variety of other malignancies, including triple-negative breast cancer.
IAM217 is a product of Iambic’s AI-driven, molecular superintelligence platform. Iambic designed IAM217 without access to a high-resolution co-crystal structure of KIF18A bound to an inhibitor. NeuralPLexer was instead leveraged to supply structural insights. The allosteric binding mode confers mechanistic selectivity over other kinesin family members and avoids the cytotoxic liabilities associated with tubulin-targeting mitotic agents. Enchant and earlier Iambic property-prediction AI tools were then deployed for large-scale multi-parameter optimization. From an initial set of 100 nM-class hits identified in 24 high-throughput experimentation plates, AI-guided design drove potency improvement to multiple 10 nM-class compounds while simultaneously optimizing oral bioavailability, reducing CYP-mediated drug-drug interaction liabilities, and engineering CNS penetrance. At the stage of lead identification, brain penetrance was achieved within approximately six months.
"We believe IAM217 has the potential to be a differentiated inhibitor for cancers that rely on KIF18A to proliferate," said Pete Olson, PhD, Chief Scientific Officer, Iambic. "With IAM217, we see the opportunity for strong anti-tumor activity in patients with brain metastases, supported by a biomarker-informed development strategy. This investigational medicine could not have been nominated without our AI-driven platform, allowing us to optimize for key properties and quickly move through IND-enabling studies."
Subject to FDA clearance of the IND, IAM217 will become Iambic’s second program to enter clinical trials. Iambic is also advancing IAM1363, a highly selective and brain-penetrant HER2 inhibitor, in an ongoing Phase 1/1b clinical trial, and anticipates submitting an IND for IAM-C1, its CDK2/4 dual inhibitor, later in the fourth quarter of 2026, and subject to FDA clearance of the IND, to initiate a Phase 1/2 trial.
(Press release, Iambic Therapeutics, OCT 5, 2026, View Source [SID1234673199])