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Xcovery Announces Initiation of Phase 3 Trial of X-396 in ALK+ Non-Small Cell Lung Cancer

Wednesday, June 29, 2016   (0 Comments)
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Xcovery Announces Initiation of Phase 3 Trial of X-396 in ALK+ Non-Small Cell Lung Cancer

Palm Beach Gardens, Fla., and Needham, Mass., June 29, 2016 – Xcovery, a developer of targeted therapeutics for cancer, today announced the initiation of its Phase 3 trial of X-396 in patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC). The eXalt3 trial is an open-label, randomized study designed to evaluate the efficacy and safety of X-396, the Company’s lead ALK inhibitor drug candidate, versus crizotinib in over 400 patients with ALK+ NSCLC.

“The initiation of our Phase 3 eXalt3 trial represents an important step forward in Xcovery’s advancement of our lead candidate, X-396,” said Michael Webb, Chief Executive Officer and President of Xcovery. “The recently released data from our ongoing Phase 1/2 study of X-396 showed promising activity with durable responses noted in both treatment-naïve patients as well in patients resistant to current standard-of-care. These results, coupled with a favorable tolerability profile, support the continued development of X-396 as a potential new treatment option for patients with ALK+ NSCLC. Xcovery will now focus on actively recruiting additional patients and new clinical sites across the globe.”

About the Phase 3 eXalt3 Study
The Phase 3 eXalt3 study is an open-label, randomized study that will evaluate the efficacy and safety of the ALK inhibitor X-396 compared to crizotinib in patients with ALK+ NSCLC. The primary efficacy endpoint being measured is progression-free survival (PFS) as assessed by an independent radiology review based on RECIST v. 1.1 criteria. The study will also allow the Company to obtain additional pharmacokinetic data on X-396 in select patients and samples for exploratory biomarkers research to be compared against the clinical outcomes. The company expects to enroll approximately 400 patients who have received up to one prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI) treatments. The trial is designed so patients either receive a 225 mg daily dose of X-396 or a 250 mg dose twice a day of standard-of-care crizotinib over a 28-day schedule.

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 eXalt2 and eXalt3 studies, Phase 2 and Phase 3 trials for the treatment of ALK‐positive non‐small cell lung cancer (NSCLC). Both studies are currently enrolling patients. To learn more, visit: www.xalt2study.com or ClinicalTrials.gov.

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.

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Company Contact:
Michael D. Webb
Xcovery President and Chief Executive Officer
(857) 202-3911
mike@xcovery.com

Media Contact:
Heather Savelle
MacDougall Biomedical Communications (781) 235‐3060
hsavelle@macbiocom.com


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