Xcovery Presents Data Supporting The Potential Efficacy Of X-396 In Patients With ALK+ Non-Small Cell Lung Cancer At The AACR Annual Meeting 2016

NEW ORLEANS & NEEDHAM, Mass.--(BUSINESS WIRE)--Xcovery, a developer of targeted therapeutics for cancer, today announced that results from the ongoing Phase I/II clinical study of its investigational tyrosine kinase inhibitor (TKI), X-396, in patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) were presented at the American Association for Cancer Research (AACR) Annual Meeting 2016 held in New Orleans, LA.

“Xcovery continues to expand the trial with the goal of providing an effective treatment option to patients suffering from this debilitating disease.”

The results presented include data from more patients, responses and safety data for all patients in the Phase I/II “Xalt2” study. Results were presented by Dr. Christine Lovly, MD, PhD, Assistant Professor of Medicine, Division of Hematology-Oncology at the Vanderbilt University School of Medicine, in a poster titled “Phase I/II trial of ensartinib (X-396), a novel anaplastic lymphoma kinase (ALK) inhibitor, in patients with ALK+ non-small cell lung cancer (NSCLC).” Ensartinib is the proposed International Non-Proprietary Name (INN), also referred to as X-396.

“Previous research has shown that X-396 can more strongly block the ALK gene product than currently approved first line treatment for ALK positive NSCLC. The data coming out of the clinic now confirms our excitement about the program by demonstrating promising therapeutic potential and a favorable and different side effect profile of X-396 as an ALK inhibitor in patients with ALK positive NSCLC,” said Dr. Lovly. “Xcovery continues to expand the trial with the goal of providing an effective treatment option to patients suffering from this debilitating disease.”

About the Phase I/II “Xalt2” Study

The data presented include safety analyses on all patients in the trial (N=63) and efficacy analyses on evaluable patients treated at doses of 200 to 250 mg per day (n=35). The presentation is based on patient information in the database as of March 14, 2016. Patient enrollment in the Xalt2 trial is continuing at a dosage of 225 mg daily.

Key data from the study include:

Safety and Tolerability – All Patients Enrolled (N=63)

• The most common adverse event (AE) related to treatment was rash in 52% of patients, mostly grade 1 or 2. Other commonly reported related AEs were nausea (29%), fatigue (25%), vomiting (24%), and pruritus (21%). No other related AEs were seen at a rate of =20%.
• The most common related grade 3 or higher AE was rash (11%); no other grade 3 or higher related AE was observed in more than one patient (<2%).

Anti-tumor Activity – Evaluable ALK+ NSCLC Patients Treated at 200 to 250 mg Daily (n=35)

• Objective response rate was 88% (7/8) in ALK-TKI treatment-naïve patients.
• ALK-TKI treatment-naïve patients have been on treatment up to 30 months, and crizotinib- resistant patients have been on treatment for up to 29 months.
• In crizotinib-resistant patients that did not receive a prior 2^nd generation ALK TKI, 16 of 19 have demonstrated reductions in target lesion dimensions.
• In patients with target CNS lesions, 5 of 8 have demonstrated reductions in CNS lesion dimension.
• Responses have been observed in patients who were resistant to both crizotinib and a 2^nd generation inhibitor.

About X-396 (Ensartinib)

Xcovery’s lead asset is X-396, a small molecule, anaplastic lymphoma kinase (ALK) inhibitor. It is being studied in the Xalt2 Study, a phase II trial for the treatment of ALK-positive non-small cell lung cancer (NSCLC). The Xalt2 Study is currently enrolling patients. To learn more, visit: www.xalt2study.com or ClinicalTrials.gov under trial identifier NCT01625234.

About NSCLC and ALK

Lung cancer is the second most common type of cancer identified in the United States with an estimated 221,000 new diagnoses expected in 2015. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for an estimated 85-90% of the lung cancer cases. The anaplastic lymphoma kinase (ALK) gene is located on chromosome 2 and rearrangement of the ALK gene can lead to its activation or expression, therefore increasing a person’s chance of developing certain types of cancer, including NSCLC. Between three and seven percent of patients with NSCLC have the ALK rearrangement, making this a molecular target warranting investigation for NSCLC patients.

About Xcovery

Xcovery is a biopharmaceutical company working to improve the lives of patients with cancer by discovering medicines to fight advanced tumors. Xcovery is developing a pipeline of oncology therapies to target a wide range of advanced tumors. For more information, visit www.xcovery.com.

Forward-Looking Statements

This press release contains forward-looking statements that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected.