KURA Kura Oncology Inc.

20.99
-0.18  -1%
Previous Close 21.17
Open 21.29
52 Week Low 6.35
52 Week High 21.755
Market Cap $1,181,381,828
Shares 56,283,079
Float 55,888,969
Enterprise Value $869,033,444
Volume 579,460
Av. Daily Volume 537,752
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Upcoming Catalysts

Drug Stage Catalyst Date
KO-539
Relapsed or refractory acute myeloid leukemia (AML)
Phase 1
Phase 1
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Tipifarnib
Chronic myelomonocytic leukemia (CMML) - cancer
Phase 2
Phase 2
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Tipifarnib
HRAS Mutant Urothelial Carcinoma
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
Tipifarnib
Head and neck squamous cell carcinomas (HNSCC) with HRAS Mutations
Phase 2
Phase 2
Phase 2 mature data presented at ASCO May 29, 2020 - Median OS of 15.4 months, median PFS of 5.9 months and ORR of 50% observed in recurrent/metastatic HRAS mutant HNSCC
KO-947
Solid tumors
Phase 1
Phase 1
Phase 1 development terminated - May 4, 2020.
Tipifarnib
Relapsed or refractory peripheral T-cell lymphoma
Phase 2
Phase 2
Registration-directed trial to be initiated in 2H 2020.
Tipifarnib - (AIM-HN/SEQ-HN)
Head and neck squamous cell carcinomas (HNSCC)
Phase 2
Phase 2
Phase 2 enrolling.

Latest News

  1. – Anticipate preliminary data presentation of menin inhibitor program, KO-539, at ASH –

    – Continued progress in registration-directed trial of tipifarnib in HRAS mutant HNSCC –

    – Opportunity to expand to HRAS and PI3K dependent tumors with potential to target up to 50% of HNSCC –

    – $338.9 million in cash, cash equivalents and investments provide runway into 2023 –

    – Management to host webcast and conference call today at 4:30 p.m. ET –

    SAN DIEGO, Aug. 06, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported second quarter 2020 financial results and provided a corporate update.

    "Last…

    – Anticipate preliminary data presentation of menin inhibitor program, KO-539, at ASH –

    – Continued progress in registration-directed trial of tipifarnib in HRAS mutant HNSCC –

    – Opportunity to expand to HRAS and PI3K dependent tumors with potential to target up to 50% of HNSCC –

    – $338.9 million in cash, cash equivalents and investments provide runway into 2023 –

    – Management to host webcast and conference call today at 4:30 p.m. ET –

    SAN DIEGO, Aug. 06, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported second quarter 2020 financial results and provided a corporate update.

    "Last quarter we implemented a number of strategic measures to focus on our two major development pillars: tipifarnib in HRAS-dependent head and neck squamous cell carcinoma (HNSCC) and KO-539 in acute myeloid leukemia (AML)," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We believe tipifarnib and KO-539 provide opportunities to address large proportions of head and neck cancers and acute leukemias, respectively. Now, following a successful public offering this past quarter, we are well-positioned to advance each of these programs toward important upcoming catalysts."

    Corporate Update

    • Encouraging progress in Phase 1/2A trial of menin inhibitor, KO-539 – KO-539 is a potent and small molecule inhibitor of the menin-KMT2A(MLL) protein-protein interaction, with the potential to target at least 35% of patients with AML. A Phase 1/2A clinical trial of KO-539 in patients with relapsed/refractory AML (KOMET-001) continues in dose escalation. Kura remains focused on its goal of reaching a recommended Phase 2 dose and schedule, after which it intends to open expansion cohorts in NPM1-mutant and KMT2A(MLL)-rearranged AML – selected patient populations where KO‑539 has the potential to demonstrate increased clinical benefit. The Company intends to submit an abstract for preliminary data presentation of the KO-539 program at the American Society of Hematology Annual Meeting in December 2020, and continues to add clinical sites to the trial in anticipation of moving into the expansion cohorts.

       
    • Updated data from Phase 2 trial of tipifarnib in HRAS mutant HNSCC – Kura reported updated clinical outcome data from a Phase 2 clinical trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC (RUN-HN) at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program in May 2020. The data showed a median overall survival of 15.4 months, median progression-free survival of 5.9 months and an overall response rate of 50% among the 18 evaluable patients. Outcomes for three FDA-approved therapies for HNSCC are poor, with reported median OS of 5-8 months, PFS of 2-3 months and ORR of 13-16% in the second line. These data further support the Company's efforts in HRAS mutant HNSCC, a disease of high unmet need.

       
    • Expanded enrollment in registration-directed trial of tipifarnib – Kura has amended its ongoing registration-directed trial of tipifarnib (AIM-HN) to enroll all recurrent or metastatic HNSCC patients with HRAS mutations, regardless of variant allele frequency, expanding the proportion of patients who are being treated in the trial. The primary outcome measure for AIM-HN remains overall response rate in patients with high HRAS mutant variant allele frequency. The amendment enables the Company to assess the potential clinical benefit of tipifarnib in the overall HRAS mutant HNSCC population as well.

       
    • Expansion opportunity for tipifarnib in HRAS and PI3K dependent tumors – Based upon the unmet need and encouraging preclinical data, Kura is prioritizing the clinical development of tipifarnib in combination with a PI3K alpha inhibitor as a strategy to treat HNSCC patients whose tumors overexpress the HRAS protein, as well as those with PI3K dependent tumors. These patients may represent significant subsets of HNSCC patients with distinct biology that may be targeted by tipifarnib, which is supported by observed activity in multiple models and in each of these subsets in preclinical studies. The Company believes that the total addressable population for tipifarnib may be as high as 50% of HNSCC.

    Financial Results

    • Research and development expenses for the second quarter of 2020 were $13.7 million, compared to $11.4 million for the second quarter of 2019.

       
    • General and administrative expenses for the second quarter of 2020 were $7.5 million, compared to $4.5 million for the second quarter of 2019.

       
    • Net loss for the second quarter of 2020 was $20.5 million, compared to a net loss of $14.9 million for the second quarter of 2019.

       
    • Cash, cash equivalents and short-term investments totaled $338.9 million as of June 30, 2020, including net proceeds of approximately $134.9 million from a public offering completed in May 2020, compared with $236.9 million as of December 31, 2019.

       
    • Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2023.

    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, August 6, 2020, to discuss the financial results for the second quarter 2020 and provide a corporate update. The live call may be accessed by dialing (866) 278-7953 for domestic callers and +1 (323) 347-3281 for international callers and entering the conference code: 1697775. 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.

    About Kura Oncology

    Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura's most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant HNSCC. The Company's pipeline is also highlighted by KO-539, a potent and selective inhibitor of the menin-KMT2A(MLL) protein-protein interaction currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed/refractory AML. For additional information about Kura, please visit the Company's website at www.kuraoncology.com.

    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's product candidates, tipifarnib and KO-539, progress and expected timing of Kura's drug development programs and clinical trials and submission of regulatory filings, the presentation of data from clinical trials, plans regarding regulatory filings and future clinical trials, the regulatory approval path for tipifarnib, the strength of Kura'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 may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, the risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with the COVID-19 global pandemic, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "promise," "potential," "expects," "plans," "anticipates," "intends," "continues," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

      
    KURA ONCOLOGY, INC. 
    Statements of Operations Data 
    (unaudited) 
    (in thousands, except per share data) 
                     
      Three Months Ended  Six Months Ended 
      June 30,  June 30, 
      2020  2019  2020  2019 
    Operating Expenses:                
    Research and development $13,697  $11,440  $26,272  $21,822 
    General and administrative  7,476   4,451   15,101   9,020 
    Total operating expenses  21,173   15,891   41,373   30,842 
    Other income, net  686   948   1,676   1,959 
    Net loss $(20,487) $(14,943) $(39,697) $(28,883)
    Net loss per share, basic and diluted $(0.40) $(0.38) $(0.82) $(0.75)
    Weighted average number of

      shares used in computing net loss

      per share, basic and diluted
      51,633   38,928   48,522   38,550 
                     



    KURA ONCOLOGY, INC. 
    Balance Sheet Data 
    (unaudited) 
    (in thousands) 
             
      June 30,  December 31, 
      2020  2019 
    Cash, cash equivalents and short-term investments $338,869  $236,891 
    Working capital  323,635   224,039 
    Total assets  353,000   241,972 
    Long-term liabilities  12,075   7,627 
    Accumulated deficit  (252,574)  (212,877)
    Stockholders' equity  322,374   218,781 



    Contacts

    Company:

    Pete De Spain

    Vice President, Investor Relations &

    Corporate Communications

    (858) 500-8803

    Investors:

    Robert H. Uhl

    Managing Director

    Westwicke ICR

    (858) 356-5932

    Media:

    Jason Spark

    Managing Director

    Canale Communications

    (619) 849-6005

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  2. SAN DIEGO, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced its participation at the 2020 Wedbush PacGrow Healthcare Virtual Conference. Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present an overview of the company on Tuesday, August 11, 2020 at 2:20 p.m. ET / 11:20 a.m. PT. The virtual conference will be held from August 11-12, 2020.

    A live audio webcast of the presentation will be available in the Investors section of Kura's website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

    About Kura

    SAN DIEGO, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced its participation at the 2020 Wedbush PacGrow Healthcare Virtual Conference. Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to present an overview of the company on Tuesday, August 11, 2020 at 2:20 p.m. ET / 11:20 a.m. PT. The virtual conference will be held from August 11-12, 2020.

    A live audio webcast of the presentation will be available in the Investors section of Kura's website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

    About Kura Oncology

    Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of two wholly owned, small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura's most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma. The Company's pipeline is also highlighted by KO-539, a potent and selective inhibitor of the menin-KMT2A(MLL) protein-protein interaction currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed/refractory acute myeloid leukemia. For additional information about Kura, please visit the Company's website at www.kuraoncology.com.

    Contacts

    Company:

    Pete De Spain

    Vice President, Investor Relations &

    Corporate Communications

    (858) 500-8803

    Investors:

    Robert H. Uhl

    Managing Director

    Westwicke ICR

    (858) 356-5932

    Media:

    Jason Spark

    Managing Director

    Canale Communications

    (619) 849-6005

    Primary Logo

    View Full Article Hide Full Article
  3. SAN DIEGO, July 30, 2020 (GLOBE NEWSWIRE) -- 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 it will report second quarter 2020 financial results after the close of U.S. financial markets on Thursday, August 6, 2020. Kura's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing (866) 278-7953 for domestic callers and (323) 347-3281 for international callers and entering the conference code: 1697775. A live webcast and archive of the call will be available online from the…

    SAN DIEGO, July 30, 2020 (GLOBE NEWSWIRE) -- 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 it will report second quarter 2020 financial results after the close of U.S. financial markets on Thursday, August 6, 2020. Kura's management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing (866) 278-7953 for domestic callers and (323) 347-3281 for international callers and entering the conference code: 1697775. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

    About Kura Oncology

    Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura's most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma. The Company's pipeline is also highlighted by KO-539, a potent and selective inhibitor of the menin-KMT2A(MLL) protein-protein interaction currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed/refractory acute myeloid leukemia. For additional information about Kura, please visit the Company's website at www.kuraoncology.com.

    Contacts

    Company:

    Pete De Spain

    Vice President, Investor Relations &

    Corporate Communications

    (858) 500-8803

    Investors:

    Robert H. Uhl

    Managing Director

    Westwicke ICR

    (858) 356-5932

    Media:

    Jason Spark

    Managing Director

    Canale Communications

    (619) 849-6005

    Primary Logo

    View Full Article Hide Full Article
  4. – Median OS of 15.4 months, median PFS of 5.9 months and ORR of 50% observed in recurrent/metastatic HRAS mutant HNSCC –

    – Outcomes with approved therapies are poor, with reported median OS of 5-8 months, PFS of 2-3 months and ORR of 13-16% in the second line –

    – Compelling single-agent activity also observed in HRAS mutant salivary gland cancer and urothelial carcinoma –

    – Data featured in oral presentation at ASCO20 Virtual Scientific Program –

    SAN DIEGO, May 29, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced updated clinical outcome data from its RUN-HN study, a Phase 2 open-label…

    – Median OS of 15.4 months, median PFS of 5.9 months and ORR of 50% observed in recurrent/metastatic HRAS mutant HNSCC –

    – Outcomes with approved therapies are poor, with reported median OS of 5-8 months, PFS of 2-3 months and ORR of 13-16% in the second line –

    – Compelling single-agent activity also observed in HRAS mutant salivary gland cancer and urothelial carcinoma –

    – Data featured in oral presentation at ASCO20 Virtual Scientific Program –

    SAN DIEGO, May 29, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced updated clinical outcome data from its RUN-HN study, a Phase 2 open-label, single-arm trial of tipifarnib in patients with HRAS mutant head and neck squamous cell carcinoma (HNSCC) whose disease had progressed after prior therapy. These data are being presented in an oral session at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program, being held May 29-31, 2020. A copy of the presentation is available on Kura's website at www.kuraoncology.com/pipeline/publications.

    At data cutoff, 21 patients with HRAS mutant HNSCC were enrolled1, of whom 18 were evaluable for efficacy. Nine of the 18 evaluable patients achieved a confirmed partial response (PR), for an objective response rate (ORR) of 50% (95% CI, 26.0 to 74.0), with a median duration of response of 14.7 months. Median progression-free survival (PFS) was 5.9 months (95% CI, 3.5 to 19.2), compared to 2.8 months on the patients' last prior therapy. Median overall survival (OS) was 15.4 months (95% CI, 7.0 to 46.4). Patients had a median of two prior lines of therapy (range 0-6). Robust activity was seen despite resistance to chemotherapy, immunotherapy and/or cetuximab.

    ORR for three FDA-approved therapies for treatment of HNSCC in the second line range from 13-16%, with median PFS of 2-3 months and median OS of 5-8 months.

    "It's encouraging to see robust overall survival data for tipifarnib, which demonstrate a potentially meaningful development for HNSCC patients with HRAS mutations in the advanced setting," said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the study. "These data add to the body of evidence emerging for tipifarnib in second line HNSCC patients, a patient population with very few treatment options and a high unmet need. These results also highlight the importance of tumor genomic profiling to identify patients with HRAS mutations who could potentially be suitable for tipifarnib treatment."

    Patients in the RUN-HN trial received tipifarnib at a starting dose of 600 or 900 mg orally twice daily on days 1-7 and 15-21 of 28-day cycles. Tipifarnib was generally well-tolerated. The most common grade 3 or 4 adverse events (AEs) seen in at least 10% of patients were cytopenias and GI disturbances.

    "We believe a median overall survival of 15 months is unprecedented in this patient population and represents a substantial improvement compared to historical benchmarks with current standard of care," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Taken together, these data support our enhanced focus on patients with HRAS mutant HNSCC, a population in desperate need of effective new treatments, and reinforce our confidence in the ongoing AIM-HN registration-directed trial."

    The AIM-HN registration-directed trial of tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC is currently recruiting at approximately 90 clinical sites in the U.S., Europe and Asia. Patients interested in participating in this trial may talk to their doctor to have their tumor tested for the HRAS mutation for eligibility to enroll in this trial. Further details regarding the trial are available at clinicaltrials.gov (NCT03719690).

    Activity in HRAS Mutant Salivary Gland Cancer and Urothelial Carcinoma

    In addition to updated clinical outcome data in patients with HRAS mutant HNSCC, Kura also reported compelling single-agent activity in tumors of the salivary gland and urothelial carcinoma with HRAS mutations.

    Seven recurrent/metastatic salivary gland cancer patients were enrolled in the all "other" HRAS mutant squamous cell carcinoma cohort in the Phase 2 tipifarnib trial and six additional patients were treated off-protocol through an expanded access program, of whom a total of 12 were evaluable for efficacy. One patient achieved a confirmed PR and seven achieved disease stabilization. Median PFS was 7.0 months (95% CI, 5.9 to 10.1) and median OS was 18.0 months (95% CI, 9.6 to 22.4). Adverse events observed were consistent with the known safety profile of tipifarnib. Salivary gland cancer is a rare disease for which standard treatments do not exist. Sequencing efforts in salivary gland cancers have identified HRAS mutations in up to 20% of high-grade histologic subtypes2,3.

    In addition, 21 patients with metastatic urothelial carcinoma were treated in an investigator-sponsored trial conducted at the Samsung Medical Center in Seoul, South Korea, including 14 patients with HRAS missense mutations, one patient with an HRAS nonsense mutation and six patients with a polymorphism in the STK11 gene. A confirmed ORR of 24% (95% CI, 6 to 42) was achieved, with all five responses seen in patients with HRAS mutations. Median PFS was 4.7 months (95% CI, 2.5 to 5.6) and median OS was 6.1 months (95% CI, 5.0 to 7.2). The most frequently observed AEs in the study were consistent with the known safety profile of tipifarnib. Approximately 6% of urothelial carcinoma patients are estimated to carry an HRAS mutation4.

    Disclosures

    Memorial Sloan Kettering (MSK) has institutional financial interests related to the research in this release in the form of intellectual property rights and associated interests by virtue of licensing agreements between MSK and Kura.

    About HNSCC

    Head and neck squamous cell carcinoma (HNSCC) accounts for more than 885,000 new cancer cases each year worldwide with many cancers arising due to tobacco and/or alcohol use or human papilloma virus (HPV) infection. Despite advances in immunotherapy, the prognosis for advanced HNSCC patients remains poor with an estimated median overall survival (OS) of 13-15 months in patients when stratified by PD-L1 expression. Although the anti-epidermal growth factor (EGFR) antibody, cetuximab, was approved more than a decade ago, development of biomarker-directed therapies in HNSCC has been stymied by the limited number of druggable targets in the genomic landscape and the challenge of managing drug refractory recurrent/metastatic HNSCC.

    About Tipifarnib

    Tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase in-licensed from Janssen in December 2014. Previously, tipifarnib was studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets; however, no molecular mechanism of action had been determined that could explain its clinical activity across a range of solid tumor and hematologic indications. Leveraging advances in next generation sequencing as well as emerging information about cancer genetics and tumor biology, the Company is seeking to identify those patients most likely to benefit from tipifarnib. Tipifarnib has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of patients with HRAS mutant HNSCC. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.

    About Kura Oncology

    Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura's most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial in patients with recurrent or metastatic HRAS mutant HNSCC. The Company's pipeline is also highlighted by KO-539, a potent and selective inhibitor of the menin-KMT2A(MLL) protein-protein interaction currently in a Phase 1/2A clinical trial in patients with relapsed/refractory acute myeloid leukemia. For additional information about Kura, please visit the Company's website at www.kuraoncology.com.

    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's product candidate tipifarnib. 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 may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with the COVID-19 global pandemic, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "promise," "potential," "confidence," "expects," "plans," "anticipated," "intends," "continues," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the company faces, please refer to the company's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura Oncology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contacts

    Company:
    Pete De Spain
    Vice President, Investor Relations &
    Corporate Communications
    (858) 500-8803

    Investors:
    Robert H. Uhl
    Managing Director
    Westwicke ICR
    (858) 356-5932

    Media:
    Jason Spark
    Managing Director
    Canale Communications
    (619) 849-6005

    1 Patients with HRAS variant allele frequency >35%, or ≥ 20% if serum albumin ≥ 3.5 g/dL, including one patient who was treated off-protocol through an expanded access program
    2 Ross JS, et al. Ann Oncol. 2017;28(10):2539-2546
    3 Kato S, et al. Oncotarget. 2015;6(28):25631-25645
    4 Der CJ. Are All RAS Proteins Created Equal in Cancer? National Cancer Institute, 2017

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  5. SAN DIEGO, May 13, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that three abstracts highlighting its drug candidate tipifarnib have been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) Virtual Scientific Program, to be held May 29-31, 2020.

    "We are pleased to announce the presentation of three clinical abstracts for tipifarnib, including an oral presentation highlighting single-agent activity in multiple solid tumors with HRAS mutations," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "In addition, the…

    SAN DIEGO, May 13, 2020 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (NASDAQ:KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that three abstracts highlighting its drug candidate tipifarnib have been accepted for presentation at the upcoming American Society of Clinical Oncology (ASCO) Virtual Scientific Program, to be held May 29-31, 2020.

    "We are pleased to announce the presentation of three clinical abstracts for tipifarnib, including an oral presentation highlighting single-agent activity in multiple solid tumors with HRAS mutations," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "In addition, the oral presentation will feature compelling overall survival data from our RUN-HN Phase 2 trial in head and neck squamous cell carcinoma (HNSCC) patients with high HRAS mutant variant allele frequency, and we look forward to sharing those data at ASCO later this month."

    The three abstracts are listed below and are now available on the ASCO meeting website at http://www.abstract.asco.org.

    Preliminary activity of tipifarnib in tumors of the head and neck, salivary gland and urothelial tract with HRAS mutations
    Oral Abstract Session: Head and Neck Cancer
    Abstract: 6504

    The AIM-HN and SEQ-HN Study: A Pivotal Study Evaluating the Efficacy of Tipifarnib in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC) with HRAS Mutations (AIM-HN) and the Impact of HRAS Mutations on Response to First Line Systemic Therapies for HNSCC (SEQ-HN)
    Poster Session: Head and Neck Cancer
    Abstract / Poster: TPS6593 / 254

    Tipifarnib, a farnesyltransferase inhibitor, for metastatic urothelial carcinoma harboring HRAS mutations
    Poster Session: Genitourinary Cancer—Kidney and Bladder
    Abstract / Poster: 5086 / 155

    Copies of the presentations will be available on Kura's website at www.kuraoncology.com/pipeline/publications/ following presentation at the meeting.

    About Tipifarnib

    Tipifarnib, is a potent, selective and orally bioavailable inhibitor of farnesyl transferase in-licensed from Janssen in December 2014. Previously, tipifarnib was studied in more than 5,000 cancer patients and showed compelling and durable anti-cancer activity in certain patient subsets; however, no molecular mechanism of action had been determined that could explain its clinical activity across a range of solid tumor and hematologic indications. Leveraging advances in next generation sequencing as well as emerging information about cancer genetics and tumor biology, the Company is seeking to identify those patients most likely to benefit from tipifarnib. Tipifarnib has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of patients with HRAS mutant HNSCC. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.

    About Kura Oncology

    Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company's pipeline consists of two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura's most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial in patients with recurrent or metastatic HRAS mutant HNSCC. The Company's pipeline is also highlighted by KO-539, a potent and selective inhibitor of the menin-KMT2A(MLL) protein-protein interaction currently in a Phase 1/2A clinical trial in patients with relapsed/refractory acute myeloid leukemia. For additional information about Kura, please visit the Company's website at www.kuraoncology.com.

    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's product candidate tipifarnib. 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 may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings and applications, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "promise," "potential," "expects," "plans," "anticipated," "intends," "continues," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the company faces, please refer to the company's periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura Oncology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

    Contacts

    Company:
    Pete De Spain
    Vice President, Investor Relations &
    Corporate Communications
    (858) 500-8803

    Investors:
    Robert H. Uhl
    Managing Director
    Westwicke ICR
    (858) 356-5932

    Media:
    Jason Spark
    Managing Director
    Canale Communications
    (619) 849-6005

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