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news.US-based Xcovery has reported positive results from a Phase I/II trial of X-396, a potent small molecule anaplastic lymphoma kinase (ALK) inhibitor, which showed that the drug is generally well-tolerated and has anti-tumor activity in patients with ALK-positive, non-small cell lung cancer (NSCLC).
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At the time of data cutoff, a total of 41 patients were enrolled with tumor types including NSCLC, head and neck, small cell lung, colorectal and breast cancers,.
The company is developing X-396 to treat solid tumours where ALK is deregulated.
X-396 has been evaluated in potency and selectivity assays indicating that it is more selective and up to ten times more potent than competitive ALK inhibitors.
Vanderbilt-Ingram Cancer Center associate professor of Medicine and Clinical Director, Thoracic Oncology Program and lead investigator of this Phase I trial Leora Horn said: "While still early, X-396 continues to demonstrate activity in treatment-naive ALK-positive non-small cell lung cancer patients as well as those that have progressed on crizotinib, and responses have also been seen in patients with central nervous system (CNS) disease.
"We are continuing to enroll patients in the expansion cohort phase of this trial to learn more about this patient population and inform future studies of X-396."
Xcovery executive vice-president and chief scientific officer Chris Liang said: "These results further validate the clinical benefit of X-396 that we presented earlier this year and our belief that X-396 has the potential to be an effective and well-tolerated oral treatment for ALK-positive, non-small cell lung cancer."