On November 5, 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 third quarter 2019 financial results and provided a corporate update (Press release, Kura Oncology, NOV 5, 2019, View Source [SID1234550330]).
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"We continue to be very encouraged by our growing body of data that support the potential of tipifarnib, highlighted recently by impressive results from our ongoing Phase 2 trial in HRAS mutant head and neck squamous cell carcinomas (HNSCC)," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "These data underscore the activity of tipifarnib in this difficult-to-treat patient population, and we believe they increase the probability of success of our registrational strategy in HRAS mutant HNSCC. We continue to execute on our AIM-HN registration-directed trial, which, if positive, will establish tipifarnib as a first-in-class farnesyl transferase inhibitor for patients with cancer. In addition, we look forward to additional data later this year from our ongoing Phase 2 trial in angioimmunoblastic T-cell lymphoma (AITL), an indication for which we are seeking regulatory feedback regarding next steps."
"Meanwhile, we continue to make steady and encouraging progress with our emerging pipeline programs," Dr. Wilson continued, "including continued dose escalation of our ERK inhibitor, KO-947, and the initiation of a Phase 1 trial of our first-in-class menin-MLL inhibitor, KO-539, in patients with relapsed or refractory acute myeloid leukemia (AML). We believe both of our early-stage drug candidates represent differentiated approaches that could potentially address large indications with high unmet need, and we look forward to sharing updates on all of our progress in the months ahead."
Recent Highlights
Durable anti-tumor activity in Phase 2 trial of tipifarnib in HRAS mutant HNSCC – Last week, Kura reported updated data from its RUN-HN Phase 2 trial of tipifarnib in HNSCC patients with high HRAS mutant variant allele frequency at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston. The preliminary results showed that 10 of the 18 efficacy-evaluable patients achieved a confirmed partial response (PR), for an objective response rate of 56%. In addition, eight patients experienced disease stabilization, including two who achieved an unconfirmed PR, one of whom was awaiting a confirmatory response assessment as of the data cutoff date. The median progression-free survival (PFS) of the 18 evaluable patients treated with tipifarnib was 6.1 months, compared to 2.8 months on their last prior therapy, including 8.3 months among patients who achieved a PR on tipifarnib and 4.5 months for those with stable disease. Patients had a median of two prior lines of therapy (range 0-6), with no responses observed on their last prior therapy.
Updated Phase 2 data support enrichment strategy in ongoing registration-directed trial – Of the eight efficacy-evaluable patients in the RUN-HN Phase 2 trial who were prospectively enrolled with high HRAS mutant variant allele frequency, three achieved a confirmed PR and five had stable disease, including two who achieved an unconfirmed PR, one of whom is awaiting a confirmatory response assessment. Kura’s registration-directed trial, AIM-HN, is designed to enroll at least 59 evaluable HNSCC patients with high HRAS mutant variant allele frequency who have received prior platinum-based therapy. AIM-HN was initiated in November 2018 and is now open in more than 75 clinical sites worldwide. The trial is expected to require approximately two years for full enrollment. Based upon the statistical assumptions, AIM-HN could be positive as soon as 15 responses are confirmed.
Positive Phase 2 trial of tipifarnib in HRAS mutant urothelial carcinoma – In September 2019, Kura reported that an investigator-sponsored Phase 2 trial of tipifarnib in HRAS mutant urothelial carcinomas met its primary efficacy endpoint prior to completion of enrollment. The trial is being conducted at the Samsung Medical Center in Seoul, South Korea. Five of the 13 evaluable patients experienced confirmed objective responses, with four patients having experienced PFS of greater than 6 months. Further analyses of the trial are ongoing, and data are expected to be presented at a medical meeting next year.
Data from Phase 2 trial of tipifarnib in AITL accepted for oral presentation at ASH (Free ASH Whitepaper). In June 2019, Kura announced that the primary endpoint was achieved in both expansion cohorts in its Phase 2 trial of tipifarnib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Additional data, including new patients from the AITL expansion cohort, have been accepted for oral presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019.
Expanded patent exclusivity for tipifarnib – In September 2019, the U.S. Patent and Trademark Office issued a new patent further extending Kura’s exclusivity to the use of any farnesyl transferase inhibitor (FTi) for the treatment of CXCL12-expressing PTCL and AML. This adds to the Company’s growing portfolio of patents involving CXCL12 pathway biomarkers and follows the issuance of another patent earlier this year that covers the use of any FTi for the treatment of HRAS mutant HNSCC. These new patents expire in 2037 and 2036, respectively, excluding any possible patent term extension. The Company continues to aggressively pursue additional intellectual property protection, both in the U.S. and abroad.
Initiated Phase 1 trial of KO-539 in relapsed or refractory AML – In September 2019, the first patient was dosed in a Phase 1 trial of KO-539, Kura’s first-in-class, potent and selective small molecule inhibitor of the menin-mixed lineage leukemia (menin-MLL) interaction. The Phase 1, open-label, dose-escalation trial is designed to determine the recommended Phase 2 dose or maximum tolerated dose of KO-539 in patients with relapsed or refractory AML. Upon completion of the dose-escalation portion of the trial, expansion cohorts are planned to further assess the safety and activity of KO-539 in specific genetic subgroups, such as patients with MLL fusions or partial tandem duplications and patients with mutations in the NPM1 oncogene.
Strengthened senior leadership team and board of directors – Kura recently added Kathleen Ford as Chief Operating Officer, James Basta as Chief Legal Officer and Diane Parks as a member of the board of directors. Previously, Ms. Ford was Senior Vice President, Head of Global Clinical Operations at Merck Serono, a division of Merck KGaA, Mr. Basta was Senior Vice President, Chief Corporation Counsel at Biogen, and Ms. Parks was most recently Senior Vice President, Head of U.S. Commercial at Kite Pharma. All three are valuable additions to Kura, as the Company continues to advance its three clinical-stage oncology assets and begins to focus on commercial readiness.
Financial Results
Research and development expenses for the third quarter of 2019 were $12.5 million, compared to $11.7 million for the third quarter of 2018.
General and administrative expenses for the third quarter of 2019 were $5.1 million, compared to $4.3 million for the third quarter of 2018.
Net loss for the third quarter of 2019 was $16.4 million, or $0.36 per share, compared to $15.0 million, or $0.40 per share, for the third quarter of 2018.
Cash, cash equivalents and short-term investments totaled $250.1 million as of September 30, 2019, compared with $179.0 million as of December 31, 2018.
Management continues to expect that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into the second half of 2021.
Upcoming Milestones
Additional data from the AITL expansion cohort in the ongoing Phase 2 trial of tipifarnib in PTCL at ASH (Free ASH Whitepaper) in December 2019
Regulatory feedback from the Phase 2 trial of tipifarnib in AITL in the first half of 2020
Additional data from the ongoing Phase 2 trial of tipifarnib in chronic myelomonocytic leukemia (CMML) in the first half of 2020
Initiation of a proof-of-concept study of tipifarnib in pancreatic cancer in 2020
Data from the Phase 2 investigator-sponsored trial of tipifarnib in urothelial carcinoma in 2020
Potential for full enrollment in the AIM-HN registration-directed trial of tipifarnib in HRAS mutant HNSCC by the end of 2020
Completion of the dose-escalation portion of the Phase 1 trial of KO-947 by the end of 2019 or early 2020
Initiation of tumor-specific extension cohort(s) in the Phase 1 trial of KO-947 in 2020
Achievement of a recommended Phase 2 dose in the Phase 1 dose-escalation trial of KO-539 in 2020
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, November 5, 2019, to discuss the financial results for the third 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: 5159117. 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 a replay will be available shortly after the live event.