On May 7, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2019 financial results and highlighted upcoming milestones (Press release, Kura Oncology, MAY 7, 2019, View Source [SID1234535880]).
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"We have made considerable progress over the past quarter, as we continue to execute against our first registration-directed trial for tipifarnib in patients with HRAS mutant squamous head and neck cancers," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Meanwhile, our elucidation of the CXCL12 pathway as a therapeutic target of tipifarnib, coupled with identification of associated farnesylated proteins, offers the potential to significantly expand the population of patients who may benefit from treatment with tipifarnib. Ultimately, we believe that CXCL12 pathway biomarkers could enable registrational strategies for tipifarnib in multiple hematologic and solid tumor indications."
"Now, we look forward to a series of important milestones," continued Dr. Wilson, "beginning with an update from our ongoing Phase 2 trial of tipifarnib in angioimmunoblastic T-cell lymphoma (AITL) and CXCL12-positive peripheral T-cell lymphoma (PTCL), which was accepted for oral presentation at both the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and the International Conference on Malignant Lymphoma (ICML) next month. This will be followed by additional data from our ongoing Phase 2 trial of tipifarnib in HRAS mutant solid tumors, including head and neck squamous cell carcinoma (HNSCC) and other squamous cell carcinomas (SCCs), as well as an update from our ongoing Phase 2 trial in chronic myelomonocytic leukemia (CMML) later in the year."
Recent Highlights
Registration-directed trial of tipifarnib in HRAS mutant HNSCC – Kura’s global, multi-center, open-label, non-comparative registration-directed trial of tipifarnib continues on track. The clinical trial has two cohorts: A non-interventional screening and outcomes cohort (SEQ-HN) and a treatment cohort (AIM-HN). AIM-HN is designed to enroll at least 59 evaluable patients with HRAS mutant HNSCC who have received prior platinum-based therapy. AIM-HN initiated in November 2018 and is expected to take approximately two years to fully enroll.
Farnesylated proteins associated with CXCL12 expression – In April 2019, Kura reported new findings at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting suggesting that gene expression of the exclusively farnesylated proteins RHOE and PRICKLE2 is strongly associated with CXCL12 expression in bone marrow stroma. These findings provide key evidence supporting the inhibition of the CXCL12 pathway as a mechanism of action mediating the activity of tipifarnib and other farnesyl transferase inhibitors.
Potential expansion to other CXCL12+ lymphoma indications – Kura reported additional findings at AACR (Free AACR Whitepaper) identifying CXCL12 expression as a potential biomarker of clinical benefit in patients with diffuse large B-cell lymphoma (DLBCL) as well as mycosis fungoides, the most common form of cutaneous T-cell lymphoma (CTCL). The results were obtained from an analysis of a subset of samples from a previously conducted Phase 2 trial of tipifarnib in patients with relapsed and refractory lymphomas and are consistent with similar findings from the Company in other indications such as PTCL, acute myeloid leukemia (AML) and pancreatic cancer.
Emerging pipeline of clinical-stage drug candidates – Kura is advancing two additional pipeline programs: KO-947, a small molecule inhibitor of extracellular signal-related kinase (ERK), and KO-539, a potent and selective small molecule inhibitor of the menin-mixed lineage leukemia (menin-MLL) interaction. The Company continues to evaluate dosing regimens for KO-947 and anticipates having data from its Phase 1 clinical trial later this year. Meanwhile, the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for KO-539 and the Company is preparing to initiate a Phase 1 clinical trial in patients with relapsed or refractory AML in mid-2019.
Financial Results
Research and development expenses for the first quarter of 2019 were $10.4 million, compared to $11.6 million for the first quarter of 2018.
General and administrative expenses for the first quarter of 2019 were $4.6 million, compared to $3.4 million for the first quarter of 2018.
Net loss for the first quarter of 2019 was $13.9 million, compared to $14.6 million for the first quarter of 2018.
Cash, cash equivalents and short-term investments totaled $165.5 million as of March 31, 2019, compared with $179.0 million as of December 31, 2018.
Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2021.
Upcoming Milestones
Additional data from the ongoing Phase 2 trial of tipifarnib in PTCL, including duration of response data from the AITL cohort and additional data from the CXCL12-positive PTCL cohort, at EHA (Free EHA Whitepaper) and ICML in June 2019
Additional data on biomarkers associated with elevated CXCL12 expression at EHA (Free EHA Whitepaper) and ICML in June 2019
Additional data from the ongoing Phase 2 trial of tipifarnib in HRAS mutant solid tumors, including HNSCC and other SCCs, in the second half of 2019
Additional data from the ongoing Phase 2 trial of tipifarnib in CMML in 2019
Data from the Phase 1 dose-escalation trial of KO-947 in 2019
Initiation of the Phase 1 clinical trial of KO-539 in mid-2019
Conference Call and Webcast
Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, May 7, 2019, to discuss the financial results for the first quarter 2019 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and entering the conference code: 4436235. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.