Kura Oncology Reports Preclinical Data Showing Ability of KO-2806 to Enhance Antitumor Activity of KRASᴳ¹²ᶜ Inhibitors in Non-Small Cell Lung Cancer
September 28 2023 - 6:30AM
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 development of its next-generation
farnesyl transferase inhibitor (FTI) KO-2806 in combination with
KRASG12C inhibitors to drive tumor regressions and durable
responses in KRASG12C-mutant non-small cell lung cancer (NSCLC).
The new findings are being presented in an oral
session today at the 5th RAS-Targeted Drug Development Summit in
Boston. A copy of the presentation, entitled “Farnesyl Transferase
Inhibitors – Evolution from Targeting HRAS to Overcoming Adaptive
Resistance to Targeted Therapies,” is available in the Posters and
Presentations section on Kura’s website.
KRASG12C inhibitors have previously been shown
to activate RTK signaling, leading to ERK-RSK and/or mTOR-S6
pathway reactivation. The Company’s new preclinical data show that
co-treatment of preclinical models of KRASG12C-mutant NSCLC with
KO-2806 and adagrasib deepens signaling inhibition at multiple
nodes, including the MAPK and mTOR pathways, while decreasing cell
proliferation. In both cell-derived (CDX) and patient-derived (PDX)
xenograft models originating from NSCLC tumors, the combination of
KO-2806 with adagrasib induced tumor regressions. In addition, the
CDX and PDX models demonstrated enhanced duration and depth of
antitumor response compared to adagrasib as a single-agent
therapy.
“Despite advances with KRAS-targeted therapies,
a significant unmet need remains for patients with KRASG12C-mutant
NSCLC as acquired resistance occurs early and often,” said Francis
Burrows, Ph.D., Senior Vice President, Translational Research. “We
are highly encouraged by these first preclinical data for KO-2806,
which demonstrate the potential for FTIs as a mechanism-based
combination agent to enhance antitumor activity of targeted
therapies, such as KRASG12C inhibitors.”
Kura is on track to dose the first patient in
its Phase 1 dose-escalation trial of KO-2806 (FIT-001) in the
second half of 2023. Concurrent with the monotherapy dose
escalation, the Company plans to evaluate KO-2806 in
dose-escalation combination cohorts with other targeted therapies
in advanced solid tumors, including clear cell renal cell carcinoma
(ccRCC) and KRASG12C NSCLC.
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 is a once-daily, oral drug
candidate targeting the menin-KMT2A protein-protein interaction for
the treatment of genetically defined acute myeloid leukemia (AML)
patients with high unmet need. Kura is currently enrolling patients
in a Phase 2 registration-directed trial of ziftomenib in
NPM1-mutant relapsed or refractory AML (KOMET-001). The Company is
also conducting a series of studies to evaluate ziftomenib in
combination with current standards of care, beginning with
venetoclax/azacitidine and standard induction
cytarabine/daunorubicin chemotherapy in NPM1-mutant and
KMT2A-rearranged newly diagnosed and relapsed/refractory AML
(KOMET-007). Tipifarnib, a potent and selective farnesyl
transferase inhibitor (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). Kura is also
preparing to evaluate KO-2806, a next-generation FTI, in a Phase 1
dose-escalation trial as a monotherapy and in combination with
other targeted therapies, beginning with ccRCC and KRASG12C-mutant
NSCLC (FIT-001). For additional information, please visit Kura’s
website at www.kuraoncology.com and follow us on Twitter 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 KO-2806, potential benefits of
combining KO-2806 with appropriate standards of care, and progress
and expected timing of the KO-2806 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, 2023 filed with
the SEC on August 9, 2023, 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 SpainExecutive Vice President,
Investor Relations &Corporate Communications(858)
500-8833pete@kuraoncology.com
Media:Alexandra WeingartenSenior Manager,
Corporate Communications(858)
500-8822alexandra@kuraoncology.com
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