Exhibit 99.1
![LOGO](https://capedge.com/proxy/8-K/0001193125-19-314539/g849850g1214055618848.jpg)
Kura Oncology Receives Fast Track Designation for Tipifarnib in HRAS Mutant HNSCC and Provides
Enrollment Guidance forAIM-HN Trial
– Fast Track designation highlights potential for tipifarnib to address unmet need for patients with HRAS mutant HNSCC –
– Registration-directedAIM-HN trial expected to complete enrollment in first quarter of 2021 –
SAN DIEGO, Dec. 16, 2019 – Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead drug candidate, tipifarnib, for the treatment of patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC) after progression on platinum therapy.
“We are very encouraged by our growing body of clinical data for tipifarnib in HRAS mutant HNSCC and believe that the FDA’s Fast Track designation puts us one step closer to delivering a precision medicine treatment for patients with this devastating disease,” said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. “We continue to work with regulatory authorities in the U.S. and abroad in our effort to bring tipifarnib to patients as quickly as possible.”
Fast Track designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application.
AIM-HN Enrollment Guidance
The Company also provided enrollment guidance forAIM-HN, its ongoing registration-directed trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC. The global, multi-center trial was initiated in November 2018 and was originally projected to take approximately two years to fully enroll. Based on a recent evaluation of current enrollment rates, the Company now expects the trial to complete enrollment in the first quarter of 2021. The slower pace of enrollment is primarily due to delays in site activation and a higher than anticipated screen failure rate. The trial is now open in more than 81 clinical sites in the U.S., Europe and Asia.