Kadmon Corporation Announces Initial Phase 1b Data For Tesevatinib In Patients With Metastatic Breast Cancer

NEW YORK, NY--(Marketwired - May 28, 2015) - Kadmon Corporation, LLC, today announced Phase 1b clinical data evaluating tesevatinib (formerly KD019), the Company’s investigational oral tyrosine kinase inhibitor, in combination with trastuzumab for the treatment of patients with HER2-positive metastatic breast cancer with brain metastases. The data presented show that the combination of tesevatinib and trastuzumab appears to be well tolerated, and one heavily pretreated patient with brain metastases had prolonged stable disease with gradual discontinuation of steroids. Detailed results will be presented in a poster session on Saturday, May 30 at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #608).

Tesevatinib is an orally available, reversible, and highly potent inhibitor of key therapeutic targets in cancer: EGFR, HER2, VEGFR2/3 and Src family kinases. Importantly, tesevatinib has shown in nonclinical models to cross the blood-brain barrier, achieving concentrations in the brain that are greater than or equivalent to levels achieved in the blood. The data presented demonstrate that tesevatinib in combination with trastuzumab was well tolerated at doses of 150 mg, 250 mg and 300 mg once daily, and one patient achieved prolonged stable disease in both peripheral and brain lesions, which is ongoing at day 106. These results support the continuation of the Phase 1b portion of the study examining tesevatinib at escalated doses of 350 mg and 400 mg once daily in patients with metastatic HER2-positive breast cancer.

“These data demonstrate that the combination of tesevatinib and trastuzumab is well tolerated at doses up to 300 mg of tesevatinib once daily and suggest that its excellent blood-brain penetration documented in animals may also occur in patients,” said Mark S. Berger, M.D., Senior Vice President, Clinical Research at Kadmon and co-author of the abstract. “These results support the continued study of tesevatinib at higher doses in HER2-positive breast cancer patients in the Phase 1b portion of the trial.”

“Brain metastases are a primary cause of morbidity and mortality in HER2-positive metastatic breast cancer, underscoring the need for therapies that cross the blood-brain barrier to effectively treat these tumors,” said Harlan W. Waksal, M.D., President and CEO at Kadmon. “We believe that tesevatinib’s inhibition of key cancer pathways, paired with its ability to cross the blood-brain barrier, makes it a potentially ideal therapy for brain metastases.”

About Kadmon Corporation
Kadmon Corporation, LLC, is a vertically 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, monogenic diseases and metabolic disease. For more information, visit www.kadmon.com.

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.