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news.Ariad Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) to start clinical development of AP32788, a tyrosine kinase inhibitor (TKI) designed to address an unmet medical need in a subset of non-small cell lung cancers (NSCLCs).
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The company expects to commence phase 1/2 clinical trial in the second quarter of this year.
AP32788 is an internally discovered product candidate designed as a targeted therapy for NSCLC patients with specific mutations in EGFR or HER2.
Tumors driven by EGFR or HER2 kinases will be targeted by AP32788, which was designed to realize selective inhibition of exon 20 insertion mutations in those kinases.
In preclinical trials, AP32788 potently inhibited EGFR mutations such as exon 20 mutations and remained selective over native EGFR.
The company said the inhibitor was also active against HER2 activating mutations including exon 20 mutations.
Ariad Pharmaceuticals president of research and development and chief scientific officer Timothy Clackson said: "Ariad scientists designed AP32788 using our integrated drug discovery program to target cancer orphan subsets that are genetically defined but have no current targeted treatment options.
"This compound specifically addresses the needs of patients with NSCLC driven by EGFR exon 20 or HER2 mutations, who currently have a poor prognosis and limited treatment options."
Ariad is working on new medicines to advance the treatment of several forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers.
The company uses computational and structural methods in designing small-molecule drugs to overcome resistance to the current cancer medicines.
Image: AP32788 (gray) shown binding to EGFR. Photo: courtesy of Business Wire.