Iambic seeks FDA clearance for second AI-designed cancer drug

Iambic Therapeutics designs experimental cancer medicines by pairing predictive AI models with automated chemistry and biology laboratories. The San Diego company said on October 5 that it had submitted an investigational new drug application to the FDA for IAM217, a KIF18A inhibitor intended for triple-negative breast cancer, ovarian cancer and other solid tumors marked by chromosomal instability. If regulators clear the application, Iambic plans a Phase 1/2 trial, making IAM217 its second program to reach human testing.

KIF18A helps align chromosomes during cell division. Iambic’s premise is that cancer cells with chromosomal instability depend on that protein more heavily than normal cells. If that selectivity holds, blocking KIF18A could provide a therapeutic window distinct from broadly cytotoxic agents that disrupt cell division, but the hypothesis still needs to be tested in people.

The design process is the more revealing part. Without a high-resolution structure showing a KIF18A inhibitor bound to its target, Iambic used NeuralPLexer to model structural information and Enchant and earlier prediction tools to optimize compounds. The company says it moved from initial hits to compounds with about tenfold greater potency while also working on oral bioavailability, central-nervous-system penetration and lower drug-interaction risk.

Iambic reported that IAM217 produced approximately 90% regression of established intracranial tumors in a preclinical brain-metastasis model. That result doesn’t establish safety or effectiveness in patients. The IND submission begins the regulatory review needed to start a trial; it is not FDA clearance to begin one.

IAM217 follows IAM1363, a brain-penetrant HER2 inhibitor already in an ongoing Phase 1/1b trial. Iambic also says it anticipates submitting an IND later in the fourth quarter for IAM-C1, a dual CDK2/4 inhibitor, although that program would likewise require FDA clearance before human testing could begin.

The clinical milestone comes shortly after a debt sale disclosed in an SEC Form D. As of the September 9 filing, Iambic had sold almost $66 million of a $66.5 million offering to 16 investors, leaving $535,000 unsold. The filing identified August 14 as the first sale date but did not establish that the full offering subsequently closed.