OncoGeneX Pharmaceuticals, Inc., a leader in the development of novel therapeutics that target important mechanisms of treatment resistance in cancer, has just announced it has signed an initial agreement contract with Teva Pharmaceutical Industries Ltd. to reclaim rights to custirsen, an experimental drug currently undergoing Phase III clinical testing as a potential treatment for lung and prostate cancer. The agreement to transfer the rights to the investigational compound is in line with the two parties’ 2009 termination of collaboration.
“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,” said Scott Cormack, President and CEO of OncoGenex, in a press release. “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 agreement between OncoGenex and Teva stipulates that upon final termination of their partnership, OncoGenex will be entitled to a $27 million payment from Teva, subject to adjustments. OncoGenex will also begin to shoulder all expenses related to the drug, including those incurred by the ENSPIRIT trial, and from manufacturing and regulatory actions, which are all at present still overseen by Teva.
OncoGenex will be allotting a portion of the $27 million payment to complete the AFFINITY trial, a study of custirsen in almost 630 metastatic Castration-Resistant Prostate Cancer (CRPC) patients who have documented disease progression after prior first-line docetaxel treatment. Completion via data readout is expected late 2015 to early 2016. The payment will also aid the advancement of the ENSPIRIT trial, a study of custirsen in ~1,100 patients with advanced or metastatic NSCLC who have progressed after initial chemotherapy treatment has failed. Second interim results from a futility analysis are expected within the first half of 2015.
Other ongoing OncoGenex trials are also expected to benefit from the Teva payment, such as completing patient enrollment in the Borealis-2 trial, and finalizing data from the Spruce and Rainier clinical trials for apatorsen, a once-weekly intravenous (IV) experimental drug designed to inhibit production of Hsp27 to disable cancer cells’ defences and overcome treatment resistance.