Partnership between Kintor and Predicine boosts possibilities
Because lung cancer resistance is associated with EGFR T790M gene mutation, its launch into the market has seen AstraZeneca’s Osimertinib break several records both in the United States and China. This fact brings an important inspiration to the pharmaceutical industry: companion diagnostics can guide the discovery of the next generation of anti-cancer drugs from cancer gene mutation arising from patients’ medication..
Recently, Predicine and Kintor Pharmaceuticals reached a global strategic cooperation agreement on precision new drug discovery, clearly reflecting the move by Chinese pharmaceuticals to follow international trends on precision new drug discovery through companion diagnostics.
In an interview, Dr. Tong Youzhi, CEO of Kintor Pharmaceuticals, emphasized that the global strategic cooperation with Predicine will involve tracking the efficacy of drug treatment to gene mutation and expression in tumor cells and launch the next generation of new drug discovery in case of possible drug resistance. This is in addition to guiding the future clinical trial design of Category 1.1 new drug Proxalutamide, and identifying patients who may respond to Proxalutamide treatment by developing biomarker-based companion diagnostics through clinical tests.
Meanwhile, Predicine’s technological innovation in the liquid biopsy and international standard laboratories operated simultaneously in China and the United States “have supported Proxalutamide’s clinical trials in both countries and provided preconditions for application with CFDA and FDA of the United States,” Dr. Tong said.
For a long time, the biggest challenge for new drug discovery pharmaceutical companies has been the R&D costs and high risks of clinical trials. The costs are as high as US$2.6 billion per 10 years for launching an anti-cancer new drug and the high risks of clinical trial failure have been the biggest pain point in drug discovery.
The companion diagnostics provides solutions. A research was undertaken in the United States on 676 clinical trials related to lung cancer from 1998 to 2012, which involved 199 compounds. The research showed that on the most concerned indicator “Phase III clinical trial success rate”, the clinical trials employing companion diagnostics reported 62% success rate while the success rate of all phase III trials was only 28%. The research showed that the biomarker-based companion diagnostics was helpful for improving success rate of Phase III clinical trials. The simultaneous approval of companion diagnostics and Osimertinib was a classical example of precision new drug discovery.
Kintor’s Proxalutamide will soon conduct Phase II and Phase III prostate cancer clinical trials in China and the United States. Clinical trial requires the highest input in the whole drug discovery cycle and the success determines its approval into the market. Therefore it is a wise strategic choice to employ companion diagnostics to improve the clinical trial success rate.
After the new drug is successfully released, companion diagnostics can boost sales in the fiercely competitive market. Today, clinical treatment emphasizes evidence-based medicine. In contrast, doctors previously prescribed medications based on experiences that has been gradually phased out Doctors tend to use therapies with predictable and quantifiable results. The companion diagnostics proved in clinical trials provides doctors with the prediction tool. Patients also tend to use drugs with predictable treatment results. The treatment fund is limited. More importantly, the best timing for the correct treatment may not be recovered once missed.
At the same time, the medical insurance payment policy is under revision. Recently the domestic medical insurance system promoted the Diagnostic Related Grouping (DRGs) payment mode. With continuous advancement in the molecular diagnostics level, DRGs may further evolve to make payment for targeted therapy according to the companion test results. Companion diagnostics will