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Xcovery Announces First Cohort of Patients Dosed in a Phase 1/2 Clinical Trial of Vorolanib in Combination with Nivolumab for Treatment of Non-Small Cell Lung Cancer or Thymic Carcinoma

August 1, 2018

PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Aug 1, 2018--Xcovery, a developer of targeted therapeutics for cancer, today announced that the first cohort of patients has been enrolled to the Phase 1/2 clinical trial evaluating the safety and efficacy of the combination of vorolanib (X-82) and nivolumab (Opdivo ® ) for the treatment of non-small cell lung cancer (NSCLC) or thymic carcinoma. Vorolanib is Xcovery’s proprietary next-generation vascular endothelial growth factor receptor (VEGFR) kinase inhibitor, while nivolumab is the first approved anti-PD-1 monoclonal antibody, developed by Bristol-Myers Squibb. This investigator-initiated trial is led by Dr. Leora Horn of the Vanderbilt-Ingram Cancer Center.

“The initiation of this trial is a significant milestone as we move forward in our mission to advance the treatment of cancer by developing therapeutics that reduce side effects and optimize the efficacy of cancer treatments for patients,” said Lieming Ding, M.D., Chairman of Xcovery. “We look forward to its initial results.”

The Phase 1/2 open label study is designed to assess the safety and response rate of vorolanib when administered in combination with nivolumab. Refractory patients with NSCLC naïve to checkpoint inhibitor therapy, NSCLC who have progressed on checkpoint inhibitor therapy, or thymic carcinoma will be enrolled. Nivolumab is the first approved drug in the class of checkpoint inhibitors that have demonstrated significant benefits to many cancer patients in recent years. It works by activating the patient’s own immune system to attack the tumor. Vorolanib may modulate the tumor microenvironment and potentiate the efficacy of checkpoint inhibitors such as nivolumab.

“Despite the success of checkpoint inhibitors, there is a need for new treatment modalities to expand the patient population who would benefit from these immunotherapies and/or to overcome resistance to immunotherapies,” said Leora Horn, M.D., Associate Professor of Medicine, Director Thoracic Oncology Research Program and Assistant Vice Chairman for Faculty Development at Vanderbilt University. “The vorolanib combination with nivolumab could be an interesting option.”

For more information on the vorolanib (X-82) combination trial, please visit ClinicalTrials.gov. (Identifier: NCT03583086).

About Vorolanib Vorolanib is a next generation VEGFR inhibitor. It was designed to have reduced toxicities for combination use. Vorolanib is being studied in advanced solid tumors including non-small cell lung cancer, thoracic tumors, renal cell carcinoma, and melanoma.

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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20180801005261/en/

CONTACT: Company Contact:

Xcovery

Kim Harrow, 561-835-9356

Vice President of Clinical Operations

kim@xcovery.com

or

Media Contact:

MacDougall Biomedical Communications

Lauren Arnold, 781-235-3060

larnold@macbiocom.com

KEYWORD: UNITED STATES NORTH AMERICA FLORIDA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS ONCOLOGY PHARMACEUTICAL

SOURCE: Xcovery

Copyright Business Wire 2018.

PUB: 08/01/2018 08:00 AM/DISC: 08/01/2018 08:01 AM

http://www.businesswire.com/news/home/20180801005261/en

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