BOTHELL, Wash.& VANCOUVER, British Columbia—Biopharmaceutical company OncoGenex Pharmaceuticals Inc., which specializes in developing and commercializing new therapies to address treatment resistance in cancer patients, has announced the execution of an initial agreement with Teva Pharmaceutical Industries Ltd. by which OncoGenex will regain the rights to custirsen, an investigational compound in Phase 3 clinical development as a treatment for prostate and lung cancers. This transfer of rights takes place in conjunction with the termination of OncoGenex and Teva's collaboration agreement, which was executed in 2009. A final agreement is expected to be executed in January 2015.
The terms of the initial agreement stipulate that, following the execution of the final agreement to terminate the collaboration, Teva will pay OncoGenex $27 million, subject to certain adjustments. In addition, OncoGenex will assume responsibility for all custirsen-related expenses, including those related wot the ENSPIRIT trial. OncoGenex will also take over manufacturing and regulatory activites for the program, which Teva is currently managing. OncoGenex reported that it expect the $27-million payment will enable the completion and final results from the AFFINITY trial, as well as the continuation of the ENSPIRIT trial through the second interim futility analysis expected in the first half of 2015.
"Teva's strategic focus has shifted away from oncology research and development. However, OncoGenex remains committed to the continued investigation of custirsen, particularly in patients who have advancing disease despite previous treatments," Scott Cormack, president and CEO of OncoGenex, commented in a statement. "This agreement provides OncoGenex with greater control of custirsen's development, including the modification of the ENSPIRIT statistical analysis plan to involve a more rigorous second interim futility analysis to be completed in the second quarter of 2015 that, if passed, would enable the trial to continue with a smaller enrollment requirement, increased confidence in success and shorter time to regulatory submission."
The AFFINITY trial is an international, randomized, open-label Phase 3 trial designed to assess the potential of custirsen to improve survival outcomes in roughly 630 men with metastatic castrate-resistant prostate cancer. In the trial, patients will receive either second-line Jevtana (cabazitaxel) and prednisone with or without custirsen. On Sept. 16, OncoGenex announced that patient enrollment for the trial had been completed.
"We are grateful to the AFFINITY investigators for their efforts, as well as the patients and their loved ones who are supporting this important trial. The pace of enrollment over the past six months has been a strong indication of the prostate cancer community's ongoing interest in custirsen, particularly in more heavily treated patients, like those in the AFFINITY trial," Cormack said in a press release regarding the enrollment completion. "OncoGenex' focus is on the science that may lead one day to preventing cancer from evading treatment, and we are pursuing this approach through the ongoing Phase 3 trials of custirsen and multiple Phase 2 trials of apatorsen in four different tumor types."