People with liver and kidney cancer are living longer, healthier lives due to recent advances in treatment options.  Onyx is committed to exploring the full potential of our therapies through a broad clinical development program.

Development

Onyx is developing a robust pipeline of novel anticancer compounds targeting multiple pathways with the goal of extending and enhancing the lives of patients living with cancer. The lead pipeline candidates include Nexavar, an oral targeted anticancer drug that is currently approved in two indications, and carfilzomib, a next-generation, selective proteasome inhibitor. Nexavar is being developed and marketed in collaboration with Bayer HealthCare Pharmaceuticals.

For Nexavar, Onyx and Bayer are conducting a comprehensive development program to realize its full potential as an anticancer agent. The goal is to leverage Nexavar's tolerability, convenient oral administration, and combinability to address significant unmet needs in the treatment of a broad range of cancers. Nexavar is currently being evaluated in randomized, Phase 3 trials in non-small cell lung cancer, thyroid cancer and as an adjuvant treatment for liver and kidney cancer. In addition, there are several studies evaluating Nexavar in combination with locoregional therapies, such as transarterial chemoembolization (TACE), and in combination with other therapies, such as erlotinib, for the treatment of liver cancer. Nexavar is also being studied in multiple Phase 2 trials in breast, colorectal, ovarian and other cancers, as well as in combination with standard chemotherapy drugs and other anticancer agents.

Beyond Nexavar, Onyx is pursuing a proteasome inhibitor development program. The proteasome has been validated as an important clinical target in cancer, and Onyx is developing next-generation proteasome inhibitors with a high degree of selectivity, with the goal of increasing therapeutic efficacy and reducing side effects.

The lead product candidate in the proteasome inhibitor program is carfilzomib, which has shown encouraging results in a broad clinical trial program in multiple myeloma. Carfilzomib is currently being evaluated as a single agent in multiple Phase 2 and Phase 1 clinical trials in patients with relapsed or refractory multiple myeloma. These trials include a Phase 2b monotherapy study in patients with relapsed and refractory multiple myeloma, the pivotal trial that could support a new drug application (NDA) filing by the end of 2010.  Carfilzomib is also being evaluated in a Phase 1b/2 study in solid tumors.

The proteasome inhibitor program also includes ONX 0912 (formerly PR-047), an oral proteasome inhibitor that is expected to enter Phase 1 testing in hematologic and solid tumors in 2010, and ONX 0914 (formerly PR-957), an immunoproteasome inhibitor with preclinical activity in models of autoimmune disorders.

In addition to Nexavar and the proteasome inhibitor program, Onyx is developing ONX 0801, a targeted alpha-folate inhibitor that recently entered a Phase 1 trial. Onyx also has options to license the rights to two Janus Kinase 2 (JAK2) inhibitors, ONX 0803, currently in Phase 1 studies to treat primary myelofibrosis, and ONX 0805, currently in preclinical development. PD 0332991, an oral, small molecule cyclin-dependent kinase 4/6 (CDK4) inhibitor, now in Phase 2 clinical development, resulted from a collaboration with Warner-Lambert Company, now Pfizer. Pfizer is responsible for all product development activities and costs. In exchange, Onyx will receive a single-digit royalty on any worldwide sales of the product.