On December 8, 2023 Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, and The Leukemia & Lymphoma Society (LLS), the largest private funder of blood cancer research, reported a clinical collaboration to evaluate Kura’s menin inhibitor, ziftomenib, in combination with chemotherapy in pediatric patients with relapsed/refractory KMT2A-rearranged, NUP98-rearranged or NPM1-mutant acute leukemia (Press release, Kura Oncology, DEC 8, 2023, View Source [SID1234638327]).

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"We are honored to be designated for the PedAL initiative, marking Kura’s continued development of ziftomenib for the treatment of acute leukemias," said Mollie Leoni, M.D., Executive Vice President, Clinical Development. "Kura remains committed to developing new treatment options across the continuum of care, including for pediatric patients with acute leukemias where poor outcomes and significant unmet medical need remain. We are proud to collaborate with an exceptional organization such as LLS, which recognizes the importance of expanding patient populations beyond adults to provide effective therapies to infants and children with blood cancers."

In partnership with the PedAL Initiative, LLS will serve as the coordinating sponsor in North America and the Princess Máxima Center for Pediatric Oncology in Utrecht, the Netherlands, will serve as the coordinating sponsor in Europe. PedAL is a pioneering global master clinical trial for Pediatric Acute Leukemia, founded and led by LLS, which aims to advance more effective, safer treatments with fewer long-term side effects, for children with blood cancer.

"We developed PedAL as part of LLS’s Dare to Dream Project to fundamentally change how children with acute leukemia are treated and to provide a clinical trial framework that would help innovative companies like Kura accelerate research into precision treatments for pediatric patients," said Gwen Nichols, M.D., Chief Medical Officer, The Leukemia & Lymphoma Society. "For too long, progress for children with cancer has lagged behind; this collaboration with Kura is a major step in the right direction."

Under the terms of the agreement, LLS and the Princess Máxima Center will sponsor the Phase 1 study of ziftomenib in pediatric patients with acute leukemias. Kura will supply LLS and the Princess Máxima Center with ziftomenib for the study.

About Ziftomenib

Ziftomenib is a novel, once-daily, oral investigational drug candidate targeting the menin-KMT2A/MLL protein-protein interaction for treatment of genetically defined AML patients with high unmet need. In the KOMET-001 Phase 1 study, ziftomenib demonstrated an encouraging safety profile and tolerability with reported events most often consistent with features and manifestations of underlying disease. Clinical activity of ziftomenib as a monotherapy was optimal at the 600 mg daily dose and a 35% complete remission rate was observed in 20 patients with NPM1-mutant AML treated at the recommended Phase 2 dose (600 mg). Ziftomenib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML. Additional information about clinical trials for ziftomenib can be found at kuraoncology.com/clinical-trials/#ziftomenib.