Kura Oncology Reports Preclinical Data Supporting Use of Tipifarnib to Prevent Emergence of Resistance to Osimertinib in Non-Small Cell Lung Cancer

– Late-breaking presentation at AACR demonstrates potential to significantly delay onset of drug resistance to EGFR-targeted therapies through combination with a farnesyl transferase inhibitor –

– Company to initiate clinical trial of tipifarnib in combination with osimertinib in NSCLC in the third quarter of 2022 –

– IND for KO-2806, a next-generation farnesyl transferase inhibitor, remains on track for submission in the fourth quarter of 2022 –

SAN DIEGO, April 08, 2022 (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 preclinical data supporting the potential of its farnesyl transferase inhibitor (FTI) tipifarnib to prevent emergence of resistance to the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor osimertinib in EGFR mutant non-small cell lung cancer (NSCLC).

The new findings, generated through a collaboration with INSERM (the French National Institute of Health and Medical Research), are being presented at the American Association for Cancer Research Annual Meeting in New Orleans. A copy of the poster, entitled “Tipifarnib prevents emergence of resistance to osimertinib in EGFR mutant NSCLC,” is available at www.kuraoncology.com. A copy of the manuscript is also available at www.biorxiv.org while it undergoes scientific peer-review for publication.

Using Rho-pathway inhibitor screening, researchers at INSERM found that tipifarnib induced a complete clearance of drug-tolerant dormant cells, a potential mechanism of resistance to EGFR-targeted therapy in NSCLC. Several farnesylated targets were identified that appear to control the ability of tumor cells to enter and exit a drug-tolerant state. In parallel, using preclinical in vivo models of EGFR-mutated lung tumors, co-treatment with tipifarnib durably prevented relapse to osimertinib for up to six months, with no evidence of toxicity. Collectively, this mechanistic and translational research strongly supports the potential use of a FTI to prevent or delay the adaptive response to osimertinib in patients with EGFR-mutated NSCLC.

“These preclinical data, combined with our own translational research, support the potential use of tipifarnib in combination with osimertinib to effectively and durably prevent relapse to EGFR-targeted therapies,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “We believe these data represent a paradigm shift in how to use FTIs in combination with targeted therapies to drive clinical benefit in large solid tumor indications. In addition to the near-term opportunity to combine FTIs with EGFR inhibitors, we continue to investigate combinations with other targeted therapies in preclinical studies that may represent additional opportunities.”

Kura is preparing to initiate a Phase I clinical trial (KURRENT-LUNG) of tipifarnib in combination with osimertinib in treatment-naïve locally advanced/metastatic EGFR mutated NSCLC and expects to dose the first patient in the third quarter of 2022. The Company intends to perform initial clinical evaluation with tipifarnib while in parallel advancing KO-2806, the lead development candidate in its next-generation FTI program, through investigational new drug (IND)-enabling studies. Kura plans to submit an IND application for KO-2806 in the fourth quarter of 2022.

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 small molecule drug candidates that target cancer signaling pathways. Ziftomenib (KO-539), a potent and selective menin inhibitor, is currently in a Phase 1b clinical trial (KOMET-001) for patients with relapsed/refractory AML, including patients with NPM1 mutations or KMT2A rearrangements. Tipifarnib, a potent, selective and orally bioavailable FTI, has received Breakthrough Therapy Designation for the treatment of patients with HRAS mutant HNSCC and is currently in a registration-directed trial (AIM-HN) in patients with this devastating disease. In addition, Kura is conducting a Phase 1/2 trial (KURRENT) of tipifarnib in combination with the PI3Kα inhibitor alpelisib to address larger genetic subsets of HNSCC patients, including those whose tumors are dependent on HRAS and/or PI3Kα pathways. The Company is also developing KO-2806, a next-generation FTI, which is intended to target innovative biology and larger oncology indications through combination regimens. 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 potential use of tipifarnib in combination with osimertinib to effectively and durably prevent relapse to EGFR-targeted therapies, the timing of activities with respect to the clinical trial of tipifarnib in combination with osimertinib in NSCLC, and the timing of submission of an IND application for KO-2806. 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, 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,” “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 (SEC), including the Company’s Form 10-K for the year ended December 31, 2021 filed with the SEC on February 24, 2022, 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.

Contacts

Company:
Pete De Spain
Senior 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