Kura Oncology Reports Second Quarter 2017 Financial Results and Provides Update on Tipifarnib Phase 2 Study
Tipifarnib demonstrates high level of clinical activity and durable partial responses in ongoing Phase 2 trial in HRAS mutant squamous cell head and neck cancers
Management to host webcast and conference call today at
“Although our data is preliminary, three responses out of the first five evaluable patients is very uncommon in the relapsed/refractory setting of SCCHN, and it underscores the potential of using small molecule drug candidates such as tipifarnib to target driver mutations such as HRAS in difficult-to-treat solid tumors,” said
“In addition to the clinical progress, we recently established a collaboration with
Update on Phase 2 Clinical Trial in HRAS Mutant Solid Tumors
An update on the progress of the HRAS mutant SCCHN clinical trial as of
- As previously reported, among the eleven evaluable patients in the first stage, two confirmed partial responses were observed out of three patients with HRAS mutant SCCHN and, as a result, the protocol was amended to enroll an additional seven patients in the second stage.
- Among the three head and neck patients enrolled in the first stage of the trial, one patient with a PR remained on study through cycle 20 and then came off study in cycle 21 due to progressive disease. The second patient with a PR is ongoing in cycle 18 of treatment. The third patient experienced tumor shrinkage and prolonged disease stabilization and withdrew from the trial at cycle 8. Each cycle is 28 days.
- In the second stage of the trial, three additional HRAS mutant SCCHN patients have been enrolled. Of those three patients, the first patient experienced a confirmed partial response according to the RECIST 1.1 criteria and is in cycle 4. The second patient is in cycle 2 and was reported as having stable disease, and the third patient is not yet evaluable for response assessment.
- Patients on the study who had failed cetuximab, alone or with chemotherapy, or immune therapy, have achieved objective partial responses upon treatment with tipifarnib. Notably, none of the five evaluable patients were reported to have experienced a PR on their prior line of therapy, and at least three of the five patients experienced only progressive disease on their prior line of therapy, including one patient receiving pembrolizumab.
- Response rates for the three agents approved for treatment of SCCHN in the second line are in the range of 13-16%, and median overall survival is up to 7.5 months.
- The Phase 2 study is ongoing, and the company is continuing to recruit patients in both the U.S. and
Europe . As the trial was initially designed, one additional, confirmed objective response is required for the trial to be positive per the study protocol. Kura anticipates providing additional data later this year and presenting the results at an upcoming scientific or medical conference.
Recent Operational Highlights
- U.S. patent issued for tipifarnib – In July, the U.S. Patent and Trademark Office issued U.S. patent 9,707,221, which is directed to the use of tipifarnib for treating patients with relapsed and/or refractory HRAS mutant SCCHN and has an expiration date of
August 2036 . - Collaboration with
Foundation Medicine – In July, Kura entered into a collaboration agreement withFoundation Medicine to support patient enrollment for Kura’s clinical program for tipifarnib in patients with relapsed and/or refractory HRAS mutant SCCHN. Through this collaboration, Foundation Medicine’s SmartTrials Precision Enrollment program will contact physicians treating individuals across the U.S. diagnosed with SCCHN whose tumors harbor HRAS mutations. - ICML and EHA presentations of clinical and preclinical data from PTCL program – In June, Kura presented clinical and preclinical data for tipifarnib in the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) at the
International Conference on Malignant Lymphoma (ICML) held in Lugano,Switzerland and theCongress of theEuropean Hematology Association (EHA) held inMadrid, Spain . - Identification of the CXCL12 chemokine as a potential biomarker of tipifarnib activity in PTCL – CXCL12 is secreted in large amounts by lymph nodes, bone marrow stroma, and liver and lung tissue, and plays key roles in tumor invasion, bone marrow homing and site of metastasis. Based on the company’s preliminary data, the identification of the CXCL12 biomarker may have the potential to unlock the therapeutic value of farnesyl transferase inhibition in PTCL and other tumor indications.
- Presented HRAS clinical data at
ASCO – In June, Kura presented a trial-in-progress poster presentation for the Phase 2 trial of tipifarnib in HRAS mutant SCCHN, including supporting rationale from patient-derived xenograft models at the ASCO Annual Meeting.
Upcoming Potential Milestones and Expectations for Clinical and Preclinical Programs
- Additional data from the Phase 2 trial of tipifarnib in HRAS mutant SCCHN in the second half of 2017.
- Additional data from the Phase 2 trial of tipifarnib in PTCL in the second half of 2017.
- Data from the Phase 2 tipifarnib trials in myelodysplastic syndromes (MDS) and in chronic myelomonocytic leukemia (CMML) in the first half of 2018.
- Data from the KO-947 Phase 1 trial in 2018.
Financial Results for the Second Quarter 2017
- Cash, cash equivalents and short-term investments totaled
$53.2 million as ofJune 30, 2017 , compared with$59.2 million as ofMarch 31, 2017 . Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into the second half of 2018. - Research and development expenses for the second quarter of 2017 were
$5.7 million , compared to$4.9 million for the second quarter of 2016. - General and administrative expenses for the second quarter of 2017 were
$2.3 million , compared to$1.9 million for the second quarter of 2016. - Net loss for the second quarter of 2017 was
$7.8 million , or$0.40 per share, compared to a net loss of$6.7 million , or$0.36 per share, for the second quarter of 2016.
Conference Call and Webcast
Kura’s management will host a webcast and conference call regarding this announcement at
About
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Kura Oncology’s product candidates and compounds, including tipifarnib, KO-947 and KO-539, progress and expected timing of Kura Oncology’s drug development programs and clinical trials, plans regarding regulatory filings and future research and clinical trials, the strength of Kura Oncology’s balance sheet and the adequacy of cash on hand. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that
KURA ONCOLOGY, INC. | |||||||||||||||||
Statements of Operations Data | |||||||||||||||||
(unaudited) | |||||||||||||||||
(in thousands, except per share data) | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
June 30, | June 30, | ||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||
Operating Expenses: | |||||||||||||||||
Research and development | $ | 5,652 | $ | 4,936 | $ | 11,165 | $ | 9,585 | |||||||||
General and administrative | 2,278 | 1,855 | 4,418 | 4,246 | |||||||||||||
Total operating expenses | 7,930 | 6,791 | 15,583 | 13,831 | |||||||||||||
Other income, net | 110 | 130 | 230 | 544 | |||||||||||||
Net loss | $ | (7,820 | ) | $ | (6,661 | ) | $ | (15,353 | ) | $ | (13,287 | ) | |||||
Net loss per share, basic and diluted | $ | (0.40 | ) | $ | (0.36 | ) | $ | (0.78 | ) | $ | (0.72 | ) | |||||
Weighted average number of shares used in computing net loss per share, basic and diluted | 19,789 | 18,548 | 19,627 | 18,397 |
KURA ONCOLOGY, INC. | ||||||||
Balance Sheet Data | ||||||||
(unaudited) | ||||||||
(in thousands) | ||||||||
June 30, | December 31, | |||||||
2017 | 2016 | |||||||
Cash, cash equivalents and short-term investments | $ | 53,244 | $ | 67,790 | ||||
Working capital | 49,659 | 63,359 | ||||||
Total assets | 55,847 | 69,821 | ||||||
Long-term liabilities | 7,134 | 7,494 | ||||||
Accumulated deficit | (69,209 | ) | (53,856 | ) | ||||
Stockholders’ equity | 43,637 | 56,876 | ||||||
CONTACT INFORMATION INVESTOR CONTACT:Robert H. Uhl Managing DirectorWestwicke Partners, LLC (858) 356-5932 robert.uhl@westwicke.com CORPORATE COMMUNICATIONS CONTACT:Mark Corbae Vice PresidentCanale Communications (619) 849-5375 mark@canalecomm.com