Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage
biopharmaceutical company committed to realizing the promise of
precision medicines for the treatment of cancer, and The Leukemia
& Lymphoma Society (LLS), the largest private funder of blood
cancer research, today announced a clinical collaboration to
evaluate Kura’s menin inhibitor, ziftomenib, in combination with
chemotherapy in pediatric patients with relapsed/refractory
KMT2A-rearranged, NUP98-rearranged or NPM1-mutant acute leukemia.
“We are honored to be designated for the PedAL
initiative, marking Kura’s continued development of ziftomenib for
the treatment of acute leukemias,” said Mollie Leoni, M.D.,
Executive Vice President, Clinical Development. “Kura remains
committed to developing new treatment options across the continuum
of care, including for pediatric patients with acute leukemias
where poor outcomes and significant unmet medical need remain. We
are proud to collaborate with an exceptional organization such as
LLS, which recognizes the importance of expanding patient
populations beyond adults to provide effective therapies to infants
and children with blood cancers.”
In partnership with the PedAL Initiative, LLS
will serve as the coordinating sponsor in North America and the
Princess Máxima Center for Pediatric Oncology in Utrecht, the
Netherlands, will serve as the coordinating sponsor in Europe.
PedAL is a pioneering global master clinical trial for
Pediatric Acute
Leukemia, founded and led by LLS, which aims to
advance more effective, safer treatments with fewer long-term side
effects, for children with blood cancer.
“We developed PedAL as part of LLS’s Dare to
Dream Project to fundamentally change how children with acute
leukemia are treated and to provide a clinical trial framework that
would help innovative companies like Kura accelerate research into
precision treatments for pediatric patients,” said Gwen Nichols,
M.D., Chief Medical Officer, The Leukemia & Lymphoma Society.
“For too long, progress for children with cancer has lagged behind;
this collaboration with Kura is a major step in the right
direction.”
Under the terms of the agreement, LLS and the
Princess Máxima Center will sponsor the Phase 1 study of ziftomenib
in pediatric patients with acute leukemias. Kura will supply LLS
and the Princess Máxima Center with ziftomenib for the study.
About Ziftomenib
Ziftomenib is a novel, once-daily, oral
investigational drug candidate targeting the menin-KMT2A/MLL
protein-protein interaction for treatment of genetically defined
AML patients with high unmet need. In the KOMET-001 Phase 1 study,
ziftomenib demonstrated an encouraging safety profile and
tolerability with reported events most often consistent with
features and manifestations of underlying disease. Clinical
activity of ziftomenib as a monotherapy was optimal at the 600 mg
daily dose and a 35% complete remission rate was observed in 20
patients with NPM1-mutant AML treated at the recommended Phase 2
dose (600 mg). Ziftomenib has received Orphan Drug Designation from
the U.S. Food and Drug Administration for the treatment
of AML. Additional information about clinical trials for ziftomenib
can be found
at kuraoncology.com/clinical-trials/#ziftomenib.
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 and azacitidine and 7+3 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
evaluating KO-2806, a next-generation FTI, in a Phase 1
dose-escalation trial as a monotherapy and in combination with
adagrasib in KRASG12C-mutated non-small cell lung cancer and
cabozantinib in clear cell renal cell carcinoma (FIT-001). For
additional information, please visit Kura’s website
at www.kuraoncology.com and follow us
on X and LinkedIn.
About PedAL Master Clinical
Trial
As part of LLS’s Dare to Dream Project, the
Pediatric Acute Leukemia Master Trial (PedAL) is the
first-of-its-kind global master clinical trial for pediatric acute
leukemia patients that will fundamentally change how children are
treated.
Prior to enrolling in therapeutic trials,
patients enroll in the PedAL Screening Trial (APAL2020SC) to
identify the unique tumor biology of each child’s cancer and help
them to match with the most promising treatment. The Screening
Trial is currently open at multiple sites in the United States,
Canada, Australia, and New Zealand; a companion Registry (EuPAL
2021 Registry) is open in Germany and more countries will open
soon. At this time, one PedAL therapeutic trial is open and
actively enrolling patients in the U.S., Canada, Australia, New
Zealand, and Europe, with more therapeutic trials planned for
global execution. To learn more about PedAL, visit
lls.org/dare-to-dream.
About The Leukemia & Lymphoma
Society (LLS)
The Leukemia & Lymphoma Society® (LLS) is
the global leader in the fight against blood cancer. The LLS
mission: Cure leukemia, lymphoma, Hodgkin's disease, and myeloma,
and improve the quality of life of patients and their families. LLS
funds lifesaving blood cancer research around the world, provides
free information and support services, and is the voice for all
blood cancer patients seeking access to quality, affordable,
coordinated care.
Founded in 1949 and headquartered in Rye Brook,
NY, LLS has regions throughout the United States and Canada. To
learn more, visit www.LLS.org. Patients should contact the
Information Resource Center at (800) 955-4572, Monday through
Friday, 9 a.m. to 9 p.m. ET.
LLS is the only organization featured in the
nonprofit category on both Fast Company’s 2022 Brands That
Matter list and the 2023 Best Workplaces for Innovators
list. LLS stands out among brands around the world for its
relevancy, cultural impact, ingenuity, and mission impact.
For additional information, visit lls.org/lls-newsnetwork.
Follow us
on Facebook, X, Instagram and LinkedIn.
About the Princess Máxima Center for
pediatric oncology
When a child is seriously ill from cancer, only
one thing matters: a cure.
Every year, 600 children in the Netherlands are
diagnosed with cancer. Sadly, one in four of these children dies.
That is why in the Princess Máxima Center for pediatric oncology,
we work together with passion and without limits every day to
improve the survival rate and quality of life of children with
cancer. Now, and in the long term. Because children have their
whole lives ahead of them.
The Princess Máxima Center is no ordinary
hospital, but a research hospital. All children with cancer in the
Netherlands are treated here, and it’s where all research into
childhood cancer in the country takes place. This makes the
Princess Máxima Center the largest pediatric cancer center in
Europe. More than 900 healthcare professionals and 450 scientists
work closely with Dutch and international hospitals to find better
treatments and new perspectives for a cure.
In this way, we offer children today the best
possible care, and we take important steps to improve survival for
children who cannot not yet be cured.
Kura’s 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, 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.
Kura 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
LLS Contacts
Media:Ryan McDonaldSenior Manager, Medical &
Science CommunicationsRyan.McDonald@lls.org
Kura Oncology (NASDAQ:KURA)
Historical Stock Chart
From Apr 2024 to May 2024
Kura Oncology (NASDAQ:KURA)
Historical Stock Chart
From May 2023 to May 2024