Exelixis and NCI's CTEP enter CRADA to further evaluate cabozantinib

Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) for further evaluation of cabozantinib, Exelixis' lead compound, in a variety of solid tumors. Cabozantinib is a potent, dual inhibitor of MET and VEGFR2. Exelixis recently announced positive phase 3 data in the EXAM trial in medullary thyroid cancer and that the company is initiating pivotal phase 3 trials in castration-resistant prostate cancer.

“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”

The agreement covers up to twenty active clinical trials per year over the lifetime of the CRADA. Under the terms of the CRADA, Exelixis and the National Cancer Institute (NCI) will undertake a series of clinical trials to evaluate the safety and efficacy of cabozantinib in several cancers based upon encouraging anti-tumor activity observed in earlier studies. The trials will be designed to address a number of scientific questions such as how the efficacy of cabozantinib compares with other VEGFR2 inhibitors, the ability of cabozantinib to overcome resistance of tumors to VEGFR2 or EGFR inhibition, and the mechanism of activity of cabozantinib in tumors metastatic to bone.

As data from the CTEP-sponsored studies and other Exelixis-sponsored trials emerge, the NCI and Exelixis will discuss additional trials to complement and support the development of cabozantinib. The NCI may also support non-clinical studies that focus on identifying assays for monitoring the biologic activity of cabozantinib, as well as combination studies of the compound with other targeted agents. Any additional studies will be with mutual agreement and approval of both parties.

"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," said Michael M. Morrissey, PhD, Exelixis' president and chief executive officer. "As we prepare to file our new drug application with the FDA for the medullary thyroid cancer indication, and continue to advance our pivotal trial plans in prostate cancer, we have found an exemplary partner in the NCI to drive clinical research in other key areas. We hope the CTEP collaboration will provide additional clinical data that will highlight cabozantinib's differentiated clinical profile in multiple different cancer indications."