On August 7, 2017 Kura Oncology, Inc., (Nasdaq:KURA) a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, reported second quarter 2017 financial results and provided a corporate update. In the company’s ongoing Phase 2 trial of tipifarnib in patients with HRAS mutant squamous cell carcinomas of the head and neck (SCCHN), partial responses have been observed in three of five evaluable patients and two of the responses have demonstrated durability beyond one year (Press release, Kura Oncology, AUG 7, 2017, View Source [SID1234520073]). Schedule your 30 min Free 1stOncology Demo! "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 Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. "Furthermore, the durability of response – beyond one year in two patients – has been impressive, particularly when considering these patients received limited clinical benefit from prior therapy before enrolling in the study. Given response rates of 13-16% and median overall survival of up to 7.5 months with the currently approved treatments in the second line, including anti-PD1 antibodies, we are very encouraged both by the response rate and the durability of response we’ve observed thus far with tipifarnib."
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"In addition to the clinical progress, we recently established a collaboration with Foundation Medicine to expand patient outreach," continued Dr. Wilson. "We also secured a U.S. patent directed to the use of tipifarnib in patients with HRAS mutant SCCHN that has an expiration date in August 2036. Together, these achievements are key elements of our strategy to advance tipifarnib to a first pivotal registrational trial in 2018, and we look forward to providing additional updates later this year."
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 July 27, 2017 is as follows:
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 with Foundation 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 (Free EHA Whitepaper) 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 the Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) held in Madrid, 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 (Free ASCO Whitepaper) – 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 (Free ASCO Whitepaper) 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 of June 30, 2017, compared with $59.2 million as of March 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.