Ono Pharmaceutical is paying Array BioPharma $31.6 million upfront for rights to develop the latter’s late-clinical-stage MEK inhibitor binimetinib and BRAF inhibitor encorafenib in Japan and South Korea. The two candidates are currently being evaluated in the Phase III COLUMBUS study as combination therapy for treating BRAF-mutant melanoma and in the Phase III BEACON CRC study as combination therapy with Erbitux® (cetuximab) against BRAF-mutant colorectal cancer (CRC). Positive topline data from Part 2 of the COLUMBUS study was reported earlier this month, with Array indicating that was on track to file an NDA during mid 2017.
Under terms of the deal with Ono, Array could earn another $156 million in development and commercial milestones, including payments relating to the BEACON CRC study, plus tiered double-digit sales royalties. Ono will carry out clinical trials of binimetinib and encorafenib in Japan and South Korea and may participate in future global development of the drugs if it contributes 12% of relevant costs.
“These two compounds have shown promising efficacy and safety in the previous clinical trials, and we believe that both compounds can be a new therapeutic option as a combination therapy for patients with BRAF-mutant melanoma, BRAF-mutant colorectal cancer, and beyond,” said Gyo Sagara, president, representative director, and CEO at Ono.
In November 2015, Array and Pierre Fabre established a global partnership for development of binimetinib and encorafenib, under which Array retained exclusive commercial rights to the drugs in the U.S., Canada, Japan, South Korea, and Israel, with Pierre Fabre retaining exclusive commercial rights in all other countries, including Europe.
Commenting on the deal with Ono, Ron Squarer, CEO at Array, said “In Ono, we selected a market leader in immuno-oncology with a rapidly growing product portfolio and recent track record of successful development and commercialization in Japan. This partnership allows us to remain focused on commercializing binimetinib and encorafenib in the U.S., while benefiting from Ono's clear expertise in these key markets.”
Array’s third clinical candidate, selumetinib, is an oral small-molecule MEK inhibitor licensed to AstraZeneca. The drug is being evaluated in two registrational studies in patients with advanced differentiated thyroid cancer and neurofibromatosis type 1. In August 2016, AstraZeneca reported disappointing results from the Phase III SELECT-1 trial evaluating selumetinib in combination with docetaxel chemotherapy as second-line therapy in patients with KRAS mutation-positive metastatic non-small-cell lung cancer.
Just yesterday, Array and Bristol-Myers Squibb (BMS) reported a clinical research collaboration to evaluate binimetinib in combination with Opdivo® (nivolumab) and in combination with Opdivo plus Yervoy® (ipilimumab) in the treatment of metastatic CRC in patients with microsatellite stable tumors.
