Kura Oncology Announces Three Abstracts Accepted for Presentation at ASCO20 Virtual Scientific Program

Rhea-AI Summary

Kura Oncology, Inc. (Nasdaq: KURA) announced acceptance of three abstracts for tipifarnib presentation at the ASCO Virtual Scientific Program scheduled for May 29-31, 2020. Highlights include an oral presentation on the drug's single-agent activity in solid tumors with HRAS mutations, featuring data from the RUN-HN Phase 2 trial on HNSCC patients. Tipifarnib, a farnesyltransferase inhibitor, has Fast Track designation for treating HRAS mutant HNSCC, with prior studies indicating durable anti-cancer activity. The abstracts are accessible on ASCO's website.

Positive

• Three abstracts accepted for presentation at ASCO, showcasing tipifarnib's potential.
• Compelling survival data will be presented from the RUN-HN Phase 2 trial.
• Tipifarnib has Fast Track designation from the FDA for HRAS mutant head and neck cancer.

Negative

• None.

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
pete@kuraoncology.com

Investors:
Robert H. Uhl
Managing Director
Westwicke ICR
(858) 356-5932
robert.uhl@westwicke.com

Media:
Jason Spark
Managing Director
Canale Communications
(619) 849-6005
jason@canalecomm.com

FAQ

What will KURA present at ASCO 2020?

Kura Oncology will present three abstracts related to tipifarnib, including its activity in solid tumors with HRAS mutations.

When is the ASCO Virtual Scientific Program?

The ASCO Virtual Scientific Program will take place from May 29 to May 31, 2020.

What is tipifarnib's significance for KURA?

Tipifarnib is significant for Kura as it has shown promising anti-cancer activity and has received Fast Track designation for specific cancer treatments.

Which clinical data will be highlighted for tipifarnib at ASCO?

The presentation will highlight compelling overall survival data from the RUN-HN Phase 2 trial in HNSCC patients.

What is the FDA designation for tipifarnib?

Tipifarnib has been granted Fast Track designation by the FDA for the treatment of HRAS mutant head and neck squamous cell carcinoma.