Firm is poised to file NDA for thyroid cancer.
Exelixis signed a cooperative research and development agreement (CRADA) with the National Cancer Institute’s (NCI) Cancer Therapy Evaluation Program (CTEP) to support further development of the firm’s lead dual MET and VEGFR2 inhibitor compound cabozantinib in a range of solid tumors. The agreement covers up to 20 active clinical trials per year over the lifetime of the CRADA. A Phase III study evaluating the drug in medullary thyroid cancer recently yielded positive results, and the firm says it is preparing to file an NDA with FDA for this indication. Exelixis is in addition initiating pivotal Phase III studies of cabozantinib in castration-resistant prostate cancer.
Under terms of the CRADA, Exelixis and the NCI will carry out a number of clinical trials to evaluate the safety and efficacy of cabozantinib in several cancers, in comparison with other VEGFR2 inhibitors. The studies will in particular focus on determining how well cabozantinib overcomes tumor resistance to VEGF2 or EGFR inhibition, and determine the mechanism of its action in bone metastases. NCI may also support nonclinical studies to identify assays for monitoring the biological activity of cabozantinib, and undertake combination studies of the compound with other targeted therapies.
“Our CRADA with the NCI’s Division of Cancer Treatment and Diagnosis reinforces our commitment to maximize the broad clinical potential of cabozantinib in a wide variety of tumor indications while focusing our own internal efforts on prostate and thyroid cancer,” comments Michael M. Morrissey, Ph.D., Exelixis’ president and CEO. “We hope the CTEP collaboration will provide additional clinical data that will highlight cobazantinib’s differentiated clinical profile in multiple cancer indications.”