On November 5, 2018 Kura Oncology, Inc., (Nasdaq: KURA) a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported third quarter 2018 financial results and provided a corporate update (Press release, Kura Oncology, NOV 5, 2018, View Source [SID1234530721]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are very encouraged by our growing body of data that support the potential of tipifarnib as a treatment for squamous cell carcinomas characterized by HRAS mutations," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "With our registration-directed trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC) now underway, we are focused on generating a data package to support an application for marketing approval in that indication, as we work to broaden the potential of tipifarnib in both HRAS mutant and non-HRAS mutant cancers. In that regard, we are encouraged by preliminary signals of clinical activity observed in patients with HRAS mutant SCCs as we believe this may represent a near-term opportunity to expand the use of tipifarnib into a broader set of HRAS mutant cancers."
"In addition," Dr. Wilson continued, "we believe the CXCL12 pathway also holds promise for identifying patients who will respond to tipifarnib, and we look forward to showing data next month at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from our ongoing Phase 2 clinical trial in patients with peripheral T-cell lymphoma (PTCL) in which we are evaluating, on a prospective basis, the role of the CXCL12 pathway and markers of bone marrow homing as potential biomarkers of clinical activity of tipifarnib."
Corporate Update
Update on positive Phase 2 trial of tipifarnib in HRAS mutant HNSCC – In October 2018, Kura reported an update on its ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress. As of the September 7, 2018 clinical data cutoff date, tumor size reductions were observed in nine of 11 evaluable patients, with five confirmed partial responses (PRs), including three patients with durable responses lasting more than 17 months. A sixth patient achieved a confirmed PR after the data cutoff. Four patients had stable disease, including two patients who experienced prolonged disease stabilization lasting more than six months. Only one patient experienced progressive disease as best response.
Preliminary results from cohort of other HRAS mutant SCCs – Preliminary results from an additional cohort of patients with other HRAS mutant squamous cell carcinomas (SCCs) were also reported at ESMO (Free ESMO Whitepaper). One of the two evaluable patients in this cohort achieved a confirmed PR and the other patient achieved prolonged disease stabilization lasting more than eight months. Four patients were not evaluable as of the data cutoff date, including two patients who were pending initial efficacy assessments.
Significant association observed between allele frequency and clinical benefit – An analysis of available tumor biopsy samples from patients in Kura’s ongoing Phase 2 trial in HNSCC/SCC cancers revealed a significant association between the allele frequency of HRAS mutations and clinical benefit. Of the 13 HNSCC and SCC patients with a tumor HRAS mutant allele frequency greater than 20%, six achieved PRs, one achieved an unconfirmed PR and two experienced disease stabilization greater than six months. No meaningful clinical benefit was observed in the seven patients with an allele frequency less than 20%. Based on these observations, Kura has introduced a minimum HRAS mutant allele frequency of 20% as an entry criterion in its registration-directed trial of tipifarnib in HRAS mutant HNSCC and is working to implement the same entry criterion in its ongoing Phase 2 study of tipifarnib in HRAS mutant SCCs.
Initiation of registration-directed trial of tipifarnib in HRAS mutant HNSCC – Earlier today, Kura announced that its registration-directed trial of tipifarnib in HRAS mutant HNSCC has been initiated and is open for enrollment. The global, multi-center trial has two cohorts: SEQ-HN, a non-interventional screening and outcomes cohort, and AIM-HN, a treatment cohort. AIM-HN is designed to enroll at least 59 patients with HRAS mutant HNSCC who have received prior platinum-based therapy. AIM-HN is expected to take approximately two years to fully enroll, with objective response rate as the primary endpoint. Based on feedback from the U.S. Food and Drug Administration, Kura believes that the trial, if positive, could support an application for accelerated approval.
Preliminary data from expansion cohorts in Phase 2 trial of tipifarnib in PTCL at ASH (Free ASH Whitepaper) – Kura is evaluating, on a prospective basis, the role of the CXCL12 pathway and markers of bone marrow homing as potential biomarkers of clinical activity for tipifarnib in various hematologic malignancies. The Company’s ongoing Phase 2 PTCL trial was the first of the three to begin and is actively enrolling patients into two cohorts: 1) patients with angioimmunoblastic T-cell lymphoma (AITL) and 2) patients with PTCL who have the absence of a single nucleotide variation in the 3’ untranslated region of the CXCL12 gene. Kura expects to provide preliminary data from these cohorts at ASH (Free ASH Whitepaper) in December 2018.
Financial Results
Research and development expenses for the third quarter of 2018 were $11.7 million, compared to $7.1 million for the third quarter of 2017.
General and administrative expenses for the third quarter of 2018 were $4.3 million, compared to $2.4 million for the third quarter of 2017.
Net loss for the third quarter of 2018 was $15.0 million, or $0.40 per share, compared to $9.3 million, or $0.38 per share, for the third quarter of 2017.
Cash, cash equivalents and short-term investments totaled $187.4 million as of September 30, 2018, compared with $93.1 million as of December 31, 2017.
Upcoming Milestones
Preliminary data from AITL and CXCL12+ cohorts in Phase 2 trial of tipifarnib in PTCL at ASH (Free ASH Whitepaper)
Additional biomarker-enriched data from other hematologic indications in 2019
Additional data from Phase 2 trial of tipifarnib in HRAS mutant SCC in 2019
Data from Phase 1 dose-escalation trial of ERK inhibitor KO-947 in 2019
Submission of an investigational new drug application for menin-MLL inhibitor KO-539 in first quarter of 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, November 5, 2018, to discuss the financial results for the third quarter of 2018 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: 6593979. 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.