US-based Iambic Therapeutics has concluded the dose escalation phase in its multi-centre Phase I/Ib trial of a brain-penetrant small molecule inhibitor targeting wild-type and oncogenic mutant human epidermal growth factor receptor 2 (HER2), IAM1363.
The open-label trial, IAM1363-01, aims to assess the pharmacokinetics (PK), tolerability, preliminary efficacy and pharmacodynamics (PD) of IAM1363 in individuals with advanced HER2 cancers.
Iambic is now progressing two tolerated doses into the dose optimisation phase of the study.
This phase focuses on subjects with HER2-altered cancers, including those with brain metastases, advanced HER2-amplified non-small cell lung cancer and any advanced cancer harbouring a HER2 tyrosine kinase domain (TKD) mutation.
With several trial sites in the US, the study is set to expand into the UK, EU and Asia-Pacific regions.
According to the company, preclinical studies have shown that the therapy showed more than 1,000-fold selectivity for HER2 over epidermal growth factor receptor (EGFR), a commendable PK and safety profile, and the ability to penetrate the central nervous system.
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By GlobalDataThe therapy has also shown favourable tolerability and efficacy in HER2 tumour models, including intracranial tumour models, versus existing TK inhibitors and HER2-targeted antibodies.
The company announced its intention to present the data from this trial at the European Society for Medical Oncology Congress in October this year.
Iambic Therapeutics chief medical officer Neil Josephson said: “We are very encouraged by the progress of the study and the pace at which we arrived at what we believe are potentially efficacious dose levels.
“IAM1363 provides us considerable flexibility to evaluate the treatment as a monotherapy and in combination with other targeted therapies as we look to address a broad range of HER2-altered cancers.”
Leveraging its AI-driven discovery and development platform, the company creates medicines.
The platform includes technologies such as Enchant and NeuralPLexer, designed to tackle complex drug discovery challenges.
Last year, the company initiated the first subject dosing of its Phase I/Ib trial of IAM1363.
