Genomics-based drug discovery firm Exelixis has submitted an investigational new drug application to the FDA seeking approval to initiate a phase I clinical trial of its novel anticancer compound, XL844.
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Exelixis believes that XL844 is the first potent, selective inhibitor of the checkpoint kinase pathway to progress to this stage of development. In addition to its therapeutic potential as a single agent, XL844 increased the effectiveness of other anticancer agents in animal models.
It is the sixth compound to advance in clinical development from the company’s internal discovery program within two years, with the filing of the XL844 an investigational new drug (IND) application coming just one week after the IND filing for XL820.
The anticancer agent’s spectrum of activity includes inhibition of two vascular endothelial growth factor receptors (VEGFR2 and VEGFR3) known to be involved in tumor angiogenesis. In preclinical studies, XL844 has demonstrated significant potency in biochemical and cellular assays, oral bioavailability and an attractive pharmacokinetic profile.