Xcovery Announces Updated Clinical Data on X-396 in Patients with ALK+ Non-Small Cell Lung Cancer at the 4th AACR-IASLC International Joint Conference

NEEDHAM, Mass. and SAN DIEGO, Jan. 8, 2016 /PRNewswire/ -- Xcovery today announced updated clinical data on its investigational tyrosine kinase inhibitor (TKI), X-396, in patients with anaplastic lymphoma kinase (ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase l/ll trial. The current results include more patients, response rates, and safety data for all patients in the trial.

The updated results from the Phase l/ll "Xalt2" trial were presented January 6 at the 4th AACR-IASLC International Joint Conference 2016.

Phase l/ll Study

These preliminary Xalt2 study findings were presented by Dr. Karen L. Reckamp, Associate Professor at the City of Hope Comprehensive Cancer Center. The data presented include safety analyses on all patients in the trial (N=57) and efficacy analyses on evaluable patients treated at doses of 200 to 250 mg per day (N=27). The presentation is based on patient information in the database as of December 9, 2015. Patient enrollment in the Xalt2 trial is continuing at a dosage of 225 mg daily.

"The updated data continues to show X-396 is an investigational ALK inhibitor with good activity in patients with ALK positive NSCLC," said Dr. Reckamp. "As the Phase l/ll trial of X-396 continues to enroll patients, we look forward to reporting additional clinical data on this agent."

Key data from the study include:

Safety and Tolerability – All Patients Enrolled (n=57)

• The most common adverse event (AE) related to treatment was rash in 49% of patients. No other related AEs were observed in greater than 30% of patients.
• Related grade 3 or higher AEs were rash (12%), fatigue (2%), decreased appetite (2%), and pruritus (2%).
• In patients taking X-396 with food, few patients reported nausea or vomiting.

Anti-tumor Activity – Evaluable ALK+ NSCLC Patients Treated at 200 to 250 mg Daily (n=27)

• Objective response rate 88% (7/8) in ALK-TKI treatment-naïve patients and 84% (10/12) in crizotinib-resistant patients.
• ALK-TKI treatment-naive patients have been on treatment up to 27 months, and crizotinib-resistant patients have been on treatment for up to 29 months.
• Responses have been observed in patients with brain metastases.

About X-396
X-396, a small molecule ALK inhibitor discovered by Xcovery's scientists, is being investigated for the treatment of ALK+ NSCLC, lymphoma and neuroblastoma. X-396 has been validated in potency and selectivity assays that demonstrate it is more selective and up to 10 times more potent than competitive ALK inhibitors tested. X-396 has also shown activity in some ALK mutations that confer resistance to other small molecule ALK inhibitors. X-396 is currently enrolling patients in Xalt2, a Phase l/ll human clinical trial.

About Non-Small Cell Lung Cancer 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 is the most common type of lung cancer, accounting for an estimated 85-90% of the lung cancer cases.

About Xcovery
Xcovery, headquartered in Needham, Massachusetts and Palm Beach Gardens, Florida, 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.

Corporate Contact:
Teri Swift
Xcovery Corporate Communications
(561) 727-9559
[email protected]

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SOURCE Xcovery