Karyopharm Therapeutics $KPTI has inked a regional Asian deal for its late-stage cancer therapy selinexor and a follow-up compound it has in the pipeline. Ono is paying $22.3 million upfront to grab development and commercial rights to the two therapies for a slate of countries that includes Japan, South Korea and Hong Kong. Ono is also on the hook for up to $170.7 million in milestones.
Karyopharm shares jumped 12% on the news.
Newton MA-based Karyopharm has had its up and downs with their lead drug selinexor.
Back in March the drug failed an overall survival goal in acute myeloid leukemia. Last fall, though, the biotech claimed a success for drug-resistant cases of multiple myeloma, with 1 in 5 of the 78 evaluable patients demonstrating an objective response characterized as a partial response or a “very good” partial response in a single-arm study.
Karyopharm subsequently added more patients to the study, looking to advance it to the FDA in 2018 if the data look good. Investigators also launched a Phase III combo study last June, adding Velcade and dexamethasone to their drug and test it among patients who had become resistant to three other drugs.
Ono also gets regional rights to KPT-8602, a followup to selinexor, which Leerink’s Michael Schmidt says could carry some nice upside. He noted:
KPT-8602 is a second generation oral SINE compound that is expected to have lower brain penetration vs. selinexor, and could potentially have improved tolerability, according to mgmt. At the ASH conference last year, early Ph I data were highlighted in relapsed/refractory multiple myeloma (r/r MM). The ongoing Ph I/II open-label study is evaluating safety and efficacy of KPT-8602, with the primary objective to determine the maximum tolerated dose (MTD) and recommended Ph II dose (RP2D) for KPT-8602 single agent and in combination with dexamethasone (dex). No dose-limiting toxicities (DLTs) were reported.
“Given ONO’s established leadership in oncology, including Opdivo (nivolumab) and Kyprolis (carfilzomib) in Japan, we believe there is no company better suited to advance both selinexor and KPT-8602 in Japan and the other licensed territories,” said Karyopharm CEO Michael Kauffman. “ONO is well-known and widely respected for its clinical development and commercial expertise, and this partnership provides important validation for both compounds, while allowing us to remain focused on executing our late-phase selinexor trials and pursue regulatory approval in the United States and European Union.”
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