Kura Oncology Announces First Patient Dosed in FIT-001 Trial of Next-Generation Farnesyl Transferase Inhibitor KO-2806
19 October 2023 - 10:30PM
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 the first patient has been dosed in the FIT-001 Phase 1
dose-escalation trial of KO-2806, the Company’s next-generation
farnesyl transferase inhibitor (FTI) for the treatment of advanced
solid tumors.
“We’re excited to advance our next-generation
FTI drug candidate into the clinical setting, underscoring our
commitment and sense of urgency to develop novel therapies for
cancer indications with high unmet medical needs,” said Troy
Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura
Oncology. “Our understanding of how to use FTIs to target
farnesylated proteins has matured significantly beyond our initial
strategy to target HRAS mutant tumors. With the success of targeted
therapies such as KRASG12C inhibitors, tyrosine kinase inhibitors
and EGFR inhibitors, there is now considerable focus on the
development of companion therapeutics that have potential to drive
enhanced antitumor activity and address mechanisms of innate and
adaptive resistance. We will focus the development of KO-2806
initially in combinations in the areas of lung cancer and renal
cell carcinomas and, if successful, we believe KO-2806 could become
the ideal combination partner for a wide range of targeted
therapies.”
FIT-001 is a Phase 1, first-in-human,
multicenter, open-label study to evaluate the safety, tolerability,
pharmacokinetics, pharmacodynamics, and preliminary antitumor
activity of KO-2806 when administered as monotherapy and in
combination with targeted therapies. Concurrent with the
monotherapy dose escalation, the Company plans to evaluate KO-2806
in dose-escalation combination cohorts with other targeted
therapies, beginning in KRASG12C-mutant non-small cell lung cancer
(NSCLC) and clear cell renal cell carcinoma (ccRCC). For more
information regarding FIT-001, please visit www.clinicaltrials.gov
(identifier: NCT06026410).
About KO-2806
KO-2806 is a next-generation inhibitor of
farnesyl transferase designed to improve upon potency,
pharmacokinetic and physicochemical properties of earlier FTI drug
candidates. Earlier this month at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics, Kura
presented promising preclinical data supporting the rationale for
combining KO-2806 with distinct classes of targeted therapies,
including tyrosine kinase inhibitors, KRASG12C inhibitors and
KRASG12D inhibitors. Additional information about clinical trials
for KO-2806 can be found at
https://kuraoncology.com/clinical-trials/#farnesyl-transferase-inhibitor.
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 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 KRASG12C-mutant NSCLC and ccRCC (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 SpainSenior 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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