Galeterone is being developed to treat castration-resistant prostate cancer (CRPC) that acts by actively disrupting AR signaling, the key driver of prostate cancer growth, via multiple mechanisms of action.
As part of the deal, Tokai will receive the exclusive right from Qiagen to its newly acquired circulating tumor cell (CTC) enrichment technology for use with galeterone, which will be incorporated into the companion diagnostic already under development by Qiagen.
Tokai Pharmaceuticals president and chief executive officer Jodie Morrison said: "We are pleased to be expanding our partnership with Qiagen with exclusive access to their newly acquired CTC enrichment technology for use with the AR-V7 companion diagnostic for galeterone.
"This access adds further support to our growing IP portfolio for galeterone for AR-V7 positive castration-resistant prostate cancer (CRPC).
"Qiagen is a global leader in liquid biopsy-based solutions for precision medicine and has the expertise to commercialize the companion diagnostic around the world.
"This global capability will be critical as we work to bring galeterone to prostate cancer patients who test positive for AR-V7, which has been linked to non-responsiveness to commonly used oral therapies.
"It is our belief that future availability of this companion diagnostic for AR-V7 will allow prostate cancer patients and their physicians to make more informed decisions regarding their care."
Qiagen’s CTC technology was used in the AR-V7 assay methods developed by the Johns Hopkins University licensed by Tokai in January 2015.
Both the firms expect that development of the AR-V7 clinical trial assay will be completed in the first half of 2015 prior to the start of the ARMOR3-SV AR-V7 metastatic CRPC registration clinical trial.
Qiagen chief executive officer Peer Schatz said: "Our partnership with Tokai Pharmaceuticals, one of the collaborations which we are pursuing with pharma in this area, is expected to result in a liquid biopsy, CTC-based test for the AR-V7 splice variant in the first half of this year, with the potential to enhance outcomes for prostate cancer patients.
"Following the success of the first-ever regulated companion diagnostic for solid tumors based on molecular biomarkers from a liquid biopsy in Europe, we are expanding our portfolio of highly accurate tests that analyze samples of body fluids that are non-invasive and more accessible than traditional tissue biopsies.
"Our liquid biopsy portfolio holds potential to create valuable insights and improve outcomes for patients."
Scheduled to be initiated in the first half of 2015, the randomized, open label Phase III ARMOR3-SV trial will compare galeterone to Xtandi (enzalutamide) in 148 metastatic CRPC treatment-naïve patients whose prostate tumors express the AR-V7 splice variant.