An IND application for IAM217 has been filed by Iambic at the FDA. The company anticipates conducting a Phase 1/2 study for IAM217. The company is developing the investigational medicine to target KIF18A, a mitotic motor protein that controls chromosome alignment. The development program targets triple-negative breast cancer, ovarian cancer, and solid tumors.
Such cancers may suffer from chromosomal instability or CIN. Tumor cells having CIN often rely on KIF18A for their cell division. However, normal cells are able to survive without KIF18A inhibition. Such differentiation may represent a potential opportunity for the drug. IAM217 led to 90% reduction of the established intracranial tumors in a preclinical brain metastasis model. The achievement indicates that the potential of the potential.
Iambic Advances AI-Driven Drug Discovery
Iambic utilized its AI-powered molecular superintelligence platform in developing IAM217. The candidate was developed in the absence of the high-resolution KIF18A co-crystal structure. The structural information for the program came from NeuralPLexer. The resulting allosteric binding provides selectivity against other proteins in the kinesin family. This method does not suffer from the toxicity issues that usually arise with tubulin targeting mitotic agents. AI from Enchant and previous Iambic technologies enabled large-scale optimization.
The researchers started with hits at 100 nM level from 24 high-throughput experimentation plates. Optimization using the AI-driven design improved potency among several 10 nM hits. Moreover, optimization ensured good oral bioavailability and minimization of drug interactions via CYP pathways. In addition, the program showed central nervous system penetration. The company attained brain penetrance in about six months during the lead identification process.
“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.”
“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.”
IAM217, upon FDA approval, will be the second drug to enter into the clinical stage for Iambic. The company currently progresses IAM1363 in a Phase 1/1b trial. IAM1363 is a selective and brain-penetrating HER2 inhibitor. Iambic is expected to file an IND for IAM-C1 towards the end of Q4 2026. IAM-C1 is a CDK2/4 dual inhibition program of Iambic. Upon FDA approval, this program can potentially go into a Phase 1/2 clinical trial.
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News Source: Businesswire.com
