WEST PALM BEACH, Fla.–(BUSINESS WIRE)–October 31, 2014–

Xcovery, a developer of next-generation targeted therapeutics for cancer, presented results at the 2014 Multidisciplinary Symposium in Thoracic Oncology from a Phase 1/2 study of X-396, a potent small molecule anaplastic lymphoma kinase (ALK) inhibitor. Data showed that X-396 is generally well-tolerated and has anti-tumor activity in patients with ALK-positive, non-small cell lung cancer (NSCLC). These data are consistent with the interim data presented at the American Society for Clinical Oncology (ASCO) in June 2014.

“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,” said Leora Horn, MD, MSc, Associate Professor of Medicine and Clinical Director, Thoracic Oncology Program at Vanderbilt-Ingram Cancer Center, Nashville, Tenn., and lead investigator of this Phase 1 study. “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.”

“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,” said Chris Liang, Ph.D., Executive Vice President and Chief Scientific Officer at the Xcovery group of companies.

At the time of data cutoff, 41 patients were enrolled with tumor types including NSCLC, head and neck, small cell lung, colorectal and breast cancers. The NSCLC (n=33) patient group included ALK-positive patients (n=23) who were either crizotinib-naïve (n=5) or received prior crizotinib (n=18), as well as ceritinib in two patients. Among the 17 ALK positive patients evaluable for response (patient completed one cycle and had post baseline response assessment), 10 patients had a partial response (59 percent) and two had stable disease (12 percent). For the five patients with progressive disease, two were at lower doses (50 mg, 100 mg) with acquired resistance to crizotinib, one (at 200 mg) had failed prior crizotinib and chemotherapy, and one (250 mg) had failed prior crizotinib and ceritinib. The patient with prior crizotinib and ceritinib had a complete response to X-396 in a retroperitoneal lymph node but progression of bone/CNS metastases.

About X-396
Xcovery is developing X-396 for the treatment of solid tumors where ALK is deregulated. X-396 has been validated in potency and selectivity assays indicating that it is more selective and up to 10 times more potent than competitive ALK inhibitors. X-396 has been active in animal models of NSCLC and neuroblastoma. Importantly, X-396 has shown activity in some ALK mutations that confer resistance to other small molecule ALK inhibitors.

About Xcovery
Xcovery is a clinical-stage company focused on the development of next-generation targeted therapeutics for cancer. Founded by Sheridan G. Snyder and Chris Liang, Ph.D., Xcovery’s vision is to successfully develop innovative oncology therapies to optimize patient outcomes. Through innovative drug design, Xcovery has developed a comprehensive pipeline of oncology therapies that target a wide range of advanced tumors. For more information, please visit www.xcovery.com.


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