Kura Oncology to Present Updated Data from KOMET-007 Combination Trial of Ziftomenib at ASH Annual Meeting

– Ziftomenib combined with 7+3 in 1L NPM1-m or KMT2A-r adverse risk AML patients selected for oral presentation on Saturday, December 7^th –

– Ziftomenib combined with ven/aza in R/R NPM1-m or KMT2A-r AML patients selected for poster presentation on Sunday, December 8th –

SAN DIEGO, Nov. 05, 2024 (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 two abstracts highlighting clinical data from the KOMET-007 combination trial of ziftomenib, the Company’s potent and selective menin inhibitor, have been accepted for presentation at the upcoming American Society of Hematology (ASH) Annual Meeting, to be held in San Diego from December 7-10, 2024.

KOMET-007 is a multicenter Phase 1 trial of ziftomenib in combination with standards of care, including cytarabine plus daunorubicin (7+3) and venetoclax/azacitidine (ven/aza), in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). The data presented at ASH will be from the Phase 1a dose-escalation portion of the study, which was conducted in newly diagnosed patients with adverse risk in combination with 7+3 and in relapsed/refractory patients with ven/aza. Notably, all four cohorts in the Phase 1a dose-escalation portion of KOMET-007 have cleared the highest dose and have advanced into the Phase 1b expansion study at 600 mg.

“The growing body of clinical data continue to support a potential best-in-class safety and tolerability profile for ziftomenib, as well as robust and durable activity in combination with standards of care,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “In the relapsed/refractory AML setting, ziftomenib combined with ven/aza is well tolerated and continues to demonstrate encouraging activity in R/R patients, including activity in previously ven-exposed NPM1-m and KMT2A-r patients. No DLTs or ziftomenib-induced QTc prolongation were reported, and events of differentiation syndrome were mitigated in combination.”

“In the AML frontline population, we are very encouraged by the safety and tolerability profile and high rates of complete response and MRD negativity as of the abstract’s June 21^st data cutoff,” Dr. Wilson continued. “We are particularly encouraged by the fact that, in the context of the very challenging 7+3 adverse risk AML patient cohorts, 100% (15/15) of the NPM1-m AML patients and 84% (16/19) of the KMT2A-r patients remained on study as of the data cutoff, approximately one year after study start. These preliminary results support the potential for ziftomenib to transform the standard of care in these high-risk patients. We look forward to sharing a more mature dataset from more than 100 patients, including data from the 600 mg cohorts, in the Phase 1a dose-escalation portion of KOMET-007, at the ASH Annual Meeting next month.”

Session titles and information for the two abstracts are listed below and are now available on the ASH online itinerary planner.

Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1-m or KMT2A-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007
Session: 616. AML: Investigational Drug & Cellular Therapies: Menin Inhibitors in AML
Date and Time: Saturday, December 7, 2024; 2:00 - 3:30 PM PT
Oral Presentation Time: 2:45 PM PT
Location: San Diego Convention Center, Ballroom 20CD
Publication Number: 214

Ziftomenib Combined with Venetoclax/Azacitidine in Relapsed/Refractory NPM1-m or KMT2A-r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET 007
Session: 616. AML: Investigational Drug & Cellular Therapies: Poster II
Date and Time: Sunday, December 8, 2024; 6:00 PM - 8:00 PM PT
Location: San Diego Convention Center, Halls G-H
Publication Number: 2880

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

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, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-m AML. Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-m AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-m and KMT2A-r AML. Kura is evaluating KO-2806, a next-generation farnesyl transferase inhibitor (FTI), in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.

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 ziftomenib, potential benefits of combining ziftomenib with appropriate standards of care, and progress and expected timing of the ziftomenib program and clinical trials. 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-Q for the quarter ended June 30, 2024 filed with the SEC on August 8, 2024, 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

Investors:
Pete De Spain
Executive Vice President, Investor Relations &
Corporate Communications
(858) 500-8833
pete@kuraoncology.com

Media:
Cassidy McClain
Vice President
Inizio Evoke Comms
(619) 849-6009
cassidy.mcclain@inizioevoke.com