Kura exits FDA clinical hold after agreeing to mitigation measures, enabling resumption of blood cancer trial
Kura Oncology is back in the game. Two months after the FDA sidelined its blood cancer trial in response to a patient death, Kura has had the partial clinical hold lifted, clearing it to resume the screening and enrollment of new patients.
San Diego-based Kura told investors to expect a short pause when the FDA imposed the partial hold back in November, reflecting a belief the agency’s request for information would be relatively simple to meet. Just under two months later, Kura has delivered on its vow to work quickly through the setback and is now ramping activities up again.
“Activities to resume patient screening are underway, and we look forward to expediting enrollment of patients in the phase 1b study and determining the recommended phase 2 dose for KO-539 in the coming months,” Kura CEO Troy Wilson said in a statement.
The FDA lifted the partial clinical hold after it reached an agreement with Kura on a mitigation strategy for differentiation syndrome, the adverse event implicated in the death that triggered the restrictions. Differentiation syndrome is a known adverse event of differentiating agents, a class that includes KO-539 and approved drugs such as Agios Pharmaceuticals’ Tibsovo, used in acute myeloid leukemia (AML).
While KO-539 shares some similarities with existing molecules, its targeting of a menin protein-protein interaction gives it a novel mechanism of action that Kura expects to have anti-tumor activity in around one-third of AML patients. Kura is initially developing KO-539 as a monotherapy in those genetic AML subtypes but also sees opportunities to enter earlier lines of therapy in combination with other drugs.
The lifting of the partial clinical hold positions Kura to resume work toward those opportunities. Kura was enrolling phase 1b expansion cohorts before the partial clinical hold to determine whether to take the 200-mg or the 600-mg dose into a registration-enabling phase 2 study.