Kura Oncology Announces FDA Clearance of Investigational New Drug Application for Menin-MLL Inhibitor KO-539

– KO-539 is a potent, selective small molecule inhibitor of the menin-MLL interaction –

– Robust anti-tumor activity observed in mixed lineage leukemias rearranged and oncogenic driver mutations in genes such as NPM1 –

– Phase 1 clinical trial in relapsed or refractory AML expected to initiate next quarter –

SAN DIEGO, CA, USA I March 05, 2019 I Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application for KO-539, a potent and selective small molecule inhibitor of the menin-mixed lineage leukemia (menin-MLL) protein-protein interaction. The Company anticipates initiating a Phase 1 clinical trial of KO-539 in relapsed or refractory acute myeloid leukemia (AML) in the second quarter of 2019.

“Despite recent advances in the treatment of AML, genetically defined subsets of acute leukemias such as MLL-rearrangements and NPM1 mutations remain areas of high unmet need,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “Our data suggest that KO-539 drives robust and persistent responses in these preclinical models by induction of differentiation in AML blasts, a mechanism that is distinct from and potentially complementary to existing therapies. We are very encouraged by these preliminary results, and we look forward to beginning clinical testing of KO-539 next quarter.”

MLL-rearranged leukemias are characterized by chromosomal translocations of the MLL gene that are primarily found in patients with AML and acute lymphoblastic leukemia (ALL), the most common type of cancer in children. These translocations form oncogenes encoding MLL fusion proteins, which play a causative role in the onset, development and progression of MLL-rearranged leukemias.

The target genes of the MLL fusion proteins are also found to be overexpressed in a broader subset of AMLs characterized by oncogenic driver mutations in genes such as NPM1. These mutations also appear to be dependent on the interaction between menin and MLL, suggesting that the menin-MLL complex is a central node in epigenetic dysregulation driven by distinct oncogenic driver mutations known to be important in AML and other hematologic malignancies.

In preclinical studies, KO-539 has demonstrated potent and selective inhibition of the proliferation of MLL-rearranged leukemia cell lines. Kura has also generated preclinical data showing robust and durable efficacy in multiple in vivo models of AML characterized by MLL-rearrangements or oncogenic driver mutations in genes such as NPM1.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura’s lead drug candidate is tipifarnib, a farnesyl transferase inhibitor, for which the Company has initiated a registration-directed trial of tipifarnib in recurrent or metastatic patients with HRAS mutant HNSCC. In addition, tipifarnib is being evaluated in multiple other Phase 2 clinical trials in solid tumor and hematologic indications. Kura’s pipeline also includes KO-947, an ERK inhibitor, currently in a Phase 1 dose-escalation trial, and KO-539, a menin-MLL inhibitor, which is anticipated to enter into a Phase 1 clinical trial in the second quarter of 2019. For additional information about Kura, please visit the Company’s website at www.kuraoncology.com.

SOURCE: Kura Oncology

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