– Kura to receive a $330
million upfront payment and up to $1.2 billion in total milestone payments,
including $420 million in near-term
milestone payments and opt-in right for solid tumors –
– Companies to jointly develop
and commercialize ziftomenib; 50/50 profit share in the U.S.;
Kura to lead U.S. development and commercial activities and book
sales; Kyowa Kirin has exclusive commercialization rights outside
the U.S. –
– Companies to jointly pursue broad development
program targeting acute leukemias, including frontline indications,
combinations with targeted therapies and post-transplant
maintenance setting –
– Kura anticipates collaboration funding along
with current cash balance to support AML program advances
through commercialization in frontline combination
therapy –
SAN
DIEGO and TOKYO,
Nov. 20,
2024 /PRNewswire/ -- Kura Oncology, Inc. (Nasdaq:
KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced they
have entered into a global strategic collaboration to develop and
commercialize ziftomenib, Kura's selective oral menin inhibitor,
being investigated for the treatment of patients with acute myeloid
leukemia (AML) and other hematologic malignancies.
Under the terms of the agreement, Kura will receive an upfront
payment of $330 million and expects
to receive up to $420 million in
near-term milestone payments, including a payment upon the launch
of ziftomenib in the monotherapy relapsed/refractory (R/R) setting.
In addition, Kura is eligible to receive additional development,
regulatory and commercial milestone payments of $741 million, totaling up to $1.161 billion in payments for milestones and the
opt-in for solid tumor indications.
In the U.S., Kura will lead development, regulatory and
commercial strategy and be responsible for manufacturing
ziftomenib. The companies will jointly perform commercialization
activities in accordance with a co-created U.S. territory
commercialization plan and will share equally in any potential
profits and losses.
Outside the U.S., Kyowa Kirin will lead development, regulatory
and commercial strategy and is responsible for commercializing
ziftomenib. Kura will be eligible to receive tiered double-digit
royalties on net product sales.
As a Japan based global
specialty pharmaceutical company, Kyowa Kirin aims to create
treatments with life-changing value that bring smiles to people
living with disease. The company will leverage its
hemato-oncology experience and capabilities, and its deep
commitment to partnerships, to successfully bring ziftomenib to
market globally.
"We believe that ziftomenib is a very promising investigational
treatment for genetically defined AML patients," said Yasuo Fujii, MBA, Chief Strategy Officer,
Managing Executive Officer of Kyowa Kirin. "The addition of
ziftomenib will complement Kyowa Kirin's existing hemato-oncology
portfolio and pipeline and expand our clinical
development efforts into combination therapies designed to generate
improved outcomes for cancer patients. We look forward to
collaborating closely with the team at Kura and adding ziftomenib
to our portfolio of oncology candidates as part of our commitment
to bringing new, advanced treatment options to patients and the
clinical community around the world."
Ziftomenib is the first and only investigational therapy to
receive breakthrough designation from the U.S. Food and Drug
Administration (FDA) for the treatment of R/R NPM1-mutant AML, a
mutation that is associated with poor
outcomes[i],[ii],[iii]. Enrollment in a Phase
2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML
has been completed and the companies anticipate submission of a New
Drug Application (NDA) in 2025. Kura 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-mutant and
KMT2A-rearranged AML. Kura expects to initiate registrational Phase
3 frontline studies in both the fit and unfit frontline AML patient
populations in 2025.
"This collaboration is an important step toward fulfilling
Kura's commitment to realizing the promise of precision medicines
for the treatment of cancer, and it substantially advances our goal
of building a sustainable, fully integrated biopharmaceutical
company," said Troy Wilson, Ph.D.,
J.D., President and Chief
Executive Officer of Kura Oncology. "Kyowa Kirin is a wonderful
partner for Kura, bringing the expertise and scale of a global
pharmaceutical company. On behalf of our leadership team and board
of directors, we are thrilled to be working with Kyowa Kirin to
realize the potential of ziftomenib as a transformational therapy
for AML patients."
Importantly," Dr. Wilson continued, "we believe the upfront and
anticipated milestone payments from this collaboration combined
with our current cash position should provide sufficient funding to
support the ziftomenib program to commercialization in the
frontline setting, which we believe is a market opportunity of up
to $3 billion annually in the U.S.
alone."
Additional Details About the Collaboration
Following regulatory approval, Kura will book sales and take the
lead role in U.S. commercial strategy development and both parties
will share in commercialization activities. Profits and losses from
the commercialization activities will be shared equally in the U.S.
Outside the U.S., Kyowa Kirin will lead and perform
commercialization activities, book sales and be responsible for the
conduct and funding of commercialization of ziftomenib, and Kura is
eligible to receive tiered double-digit royalties on net product
sales.
As part of the strategic collaboration, the companies will share
responsibility for the conduct of clinical trials delineated within
an agreed-upon global development plan. For the global development
plan, Kura will fund the development costs until the end of 2028,
and from 2029 onwards, both companies will share the costs at a
50:50 ratio. The companies will share equally the funding of future
trials in the U.S. The agreement includes plans to launch multiple
Phase 2 and Phase 3 studies of ziftomenib in AML and other
hematologic malignancies over the next several years. Development
and commercialization activities under the collaboration will be
managed through a shared governance structure.
Under the Agreement, Kyowa Kirin has an option to participate in
the development and commercialization of ziftomenib in
gastrointestinal stromal tumors (GIST) and other solid tumor
indications upon opt-in after receipt of clinical data from the
ongoing proof-of-concept study evaluating ziftomenib and imatinib
in patients with advanced GIST not successfully treated with
imatinib. If Kyowa Kirin exercises its option, Kura is eligible for
upfront and milestone payments totaling $228
million and the parties' roles and responsibilities follow
the same structure as the collaboration in AML and other heme
malignancies. Excluded from the collaboration are Kura's ongoing
efforts to advance multiple, next-generation menin inhibitor drug
candidates targeting certain oncology indications, as well as
diabetes and other metabolic diseases.
Kura was advised in the transaction by BofA Securities and
represented by Cooley LLP.
Conference Call
Kura will host a webcast and conference call featuring
management from both companies at 5:30 pm
ET today, November 20, 2024.
The live call may be accessed by dialing (800) 715-9871 for
domestic callers and (646) 307-1963 for international callers and
entering the conference ID: 6978447. A live webcast will be
available here and in the Investors section of Kura's website, with
an archived replay available shortly after the event.
About Ziftomenib
Ziftomenib is a selective and oral menin inhibitor currently in
development for the treatment of genetically defined AML patients
with high unmet need. In April 2024,
ziftomenib received Breakthrough Therapy Designation (BTD) by the
FDA for the treatment of R/R NPM1-mutant AML based on data from
Kura's ongoing KOMET-001 clinical trial. 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, a once-daily, oral drug candidate targeting the
menin-KMT2A protein-protein interaction, has received BTD for the
treatment of R/R NPM1-mutant AML. Kura has completed enrollment in
a Phase 2 registration-directed trial of ziftomenib in R/R
NPM1-mutant 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-mutant and KMT2A-rearranged 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.
About Kyowa Kirin
Kyowa Kirin aims to discover and deliver novel medicines and
treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical
Company, Kyowa Kirin has invested in drug discovery and
biotechnology innovation for more than 70 years and is currently
working to engineer the next generation of antibodies and cell and
gene therapies with the potential to help patients with high unmet
medical needs, such as bone & mineral, intractable
hematological diseases/hematology and rare diseases. A shared
commitment to Kyowa Kirin's values, to sustainable growth, and to
making people smile unites Kyowa Kirin across the globe. You can
learn more about the business of Kyowa Kirin at
www.kyowakirin.com.
Kura 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, Kura's potential receipt of
milestone payments and tiered double-digit royalties under the
collaboration; the pursuit of a broad ziftomenib development
program including frontline indications, combinations with targeted
therapies and post-transplant maintenance setting; Kura's ability
to fund its AML program to commercialization in frontline
combinations through the collaboration plus its current cash
balance; 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, including the timing of
submission of an NDA and initiation of registrational Phase 3
frontline studies; the market opportunity of ziftomenib in the
frontline setting; plans to launch multiple Phase 2 and Phase 3
studies of ziftomenib in AML and other hematologic malignancies
over the next several years; and Kura's potential receipt of
additional upfront and milestone payments If KKC exercises its
option. 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, the
risk that the collaboration is unsuccessful, 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 September 30, 2024
filed with the SEC on November 7,
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.
i Burrows F et al. Poster presented at:
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics: Discovery, Biology, and Clinical Applications;
October 26-30, 2017; Philadelphia, PA
ii Issa GC et al. Blood Adv. 2023;7(6):933-942.
doi:10.1182/bloodadvances.2022008316
iii Ostronoff F et al. J Clin Oncol.
2015;33(10):1157-1164. doi:10.1200/JCO.2014.58.0571
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