SOURCE: Kadmon Corporation

Kadmon Corporation

December 18, 2015 09:15 ET

Kadmon Corporation Initiates Phase 2 Clinical Trial Evaluating Tesevatinib in Non-Small Cell Lung Cancer With Activating EGFR Mutations and Brain Metastases or Leptomeningeal Disease

Initial Data Expected mid-2016

NEW YORK, NY--(Marketwired - Dec 18, 2015) - Kadmon Corporation, LLC, today announced that the first patient has been dosed in a Phase 2 clinical trial of tesevatinib, the Company's investigational tyrosine kinase inhibitor, for the treatment of non-small cell lung cancer (NSCLC) in patients who have activating mutations of the epidermal growth factor receptor (EGFR) gene, prior treatment with a tyrosine kinase inhibitor, and whose disease has metastasized to the brain or leptomeninges (the membrane lining the brain and spinal cord). The open-label, multicenter study examines tesevatinib administered at 300 mg daily in up to 40 patients in the United States.

Lung cancer is the leading cause of cancer deaths worldwide. Brain metastases are a common and often lethal complication of NSCLC, with a median survival period of only three to four months. There are no approved treatments for NSCLC patients with activating EGFR mutations whose cancer has spread to the brain or the leptomeninges, representing a significant unmet medical need.

Tesevatinib is a potent inhibitor of EGFR, a key molecular driver of cancer. Tesevatinib has been shown in nonclinical studies to cross the blood-brain barrier, a critical shortcoming of current therapies that limits their ability to reach and effectively treat central nervous system (CNS) metastases and primary tumors. In these studies, tesevatinib reached equal concentrations in the brain as in blood and accumulated more than 15-fold in the leptomeninges compared to levels in blood, suggesting that tesevatinib penetrates into these tissues to effectively treat metastases. In a previous Phase 2 study, tesevatinib showed significant clinical activity and achieved a 57% response rate in previously untreated NSCLC patients with activating EGFR mutations.

"We believe that tesevatinib's novel set of characteristics -- its potent EGFR inhibition, blood-brain barrier penetrance and accumulation in the leptomeninges -- make it ideally suited to treat these NSCLC patients for whom there are no approved therapies," said Harlan W. Waksal, M.D., President and Chief Executive Officer at Kadmon. "We expect to see initial results of this Phase 2 study by mid-2016, and may expand this study or initiate a registration study in these patient populations for whom effective therapies are desperately needed."

In addition to the ongoing Phase 2 study in NSCLC, Kadmon plans to initiate a Phase 2 study of tesevatinib in glioblastoma in 2016. Kadmon is also studying tesevatinib for the treatment of autosomal dominant polycystic kidney disease (ADPKD) and autosomal recessive polycystic kidney disease (ARPKD).

About Kadmon Corporation
Kadmon Corporation, LLC is a fully integrated biopharmaceutical company focused on developing innovative products for significant unmet medical needs. We have a diversified product pipeline in autoimmune and fibrotic diseases, oncology, genetic and metabolic diseases.

This press release contains forward-looking statements. These forward-looking statements are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of original issue. Kadmon expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

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    Ellen Tremaine
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