Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage
biopharmaceutical company committed to realizing the promise of
precision medicines for the treatment of cancer, and Mirati
Therapeutics, Inc. (NASDAQ: MRTX), a commercial-stage targeted
oncology company, today announced a clinical collaboration and
supply agreement to evaluate the combination of KO-2806, a
next-generation farnesyl transferase inhibitor (FTI), and
adagrasib, a highly selective KRASG12C inhibitor, in patients with
KRASG12C-mutated non-small cell lung cancer (NSCLC).
“Recent findings suggest that combining KO-2806 with adagrasib
can drive tumor regressions and enhance both duration and depth of
antitumor response in preclinical models of KRASG12C-mutated
NSCLC,” said Stephen Dale, M.D., Chief Medical Officer of Kura
Oncology. “This collaboration highlights the potential to address
the urgent need for more durable and effective treatment options
for patients with advanced solid tumors, and we look forward to
collaborating with Mirati, an established leader in targeted
oncology.”
“We are pleased to collaborate with Kura Oncology on this
clinical study of KO-2806 with adagrasib. Preclinical work
demonstrates the ability of adagrasib, in combination with a FTI,
to improve patient outcomes,” said Alan Sandler, M.D., Chief
Medical Officer, Mirati Therapeutics. “This collaboration
exemplifies the potential combinability of adagrasib as a key
differentiation from other KRASG12C inhibitors.”
Under the terms of the agreement, Kura will sponsor the Phase 1
study of KO-2806 and adagrasib in patients with KRASG12C-mutated
NSCLC. Mirati will supply Kura with adagrasib for the study.
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 year, Kura received FDA clearance of its Investigational New
Drug application for KO-2806. In addition to KRASG12C NSCLC,
KO-2806 has demonstrated encouraging preclinical activity in clear
cell renal cell carcinoma (ccRCC). The Company recently dosed the
first patients in a Phase 1 dose-escalation trial of KO-2806
(FIT-001). Concurrent with dose escalation as a monotherapy, Kura
also plans to evaluate KO-2806 in dose-escalation combination
cohorts with other targeted therapies in advanced solid tumors,
including adagrasib in KRASG12C-mutated NSCLC and a tyrosine kinase
inhibitor in ccRCC.
About Adagrasib
Adagrasib is being evaluated as monotherapy and in combination
with other anti-cancer therapies in patients with advanced
KRASG12C-mutated solid tumors, including NSCLC, colorectal cancer,
and pancreatic cancer. For more information,
visit Mirati.com/science.
KRAZATI (adagrasib)
U.S. Indication
KRAZATI is indicated for the treatment of adult patients with
KRASG12C-mutated locally advanced or metastatic non-small cell lung
cancer (NSCLC), as determined by an FDA-approved test, who have
received at least one prior systemic therapy.
This indication is approved under accelerated approval based on
objective response rate (ORR) and duration of response (DOR).
Continued approval for this indication may be contingent upon
verification and description of a clinical benefit in a
confirmatory trial(s). For Prescribing Information,
visit Mirati.com/KRAZATI_USPI.
KRAZATI (adagrasib)
Important Safety Information
WARNINGS AND PRECAUTIONS
Gastrointestinal Adverse Reactions
- In the pooled safety population, serious gastrointestinal
adverse reactions observed were gastrointestinal obstruction in
1.6%, including 1.4% grade 3 or 4, gastrointestinal bleeding in
0.5% of patients, including 0.5% grade 3, and colitis in 0.3%,
including 0.3% grade 3. In addition, nausea, diarrhea, or vomiting
occurred in 89% of 366 patients, including 9% grade 3. Nausea,
diarrhea, or vomiting led to dosage interruption or dose reduction
in 29% of patients and permanent discontinuation of KRAZATI in
0.3%
- Monitor and manage patients using supportive care, including
antidiarrheals, antiemetics, or fluid replacement, as indicated.
Withhold, reduce the dose, or permanently discontinue KRAZATI based
on severity
QTc Interval Prolongation
- KRAZATI can cause QTc interval prolongation, which can increase
the risk for ventricular tachyarrhythmias (eg, torsades de pointes)
or sudden death
- In the pooled safety population, 6% of 366 patients with at
least one post-baseline electrocardiogram (ECG) assessment had an
average QTc ≥501 ms, and 11% of patients had an increase from
baseline of QTc >60 msec. KRAZATI causes concentration-dependent
increases in the QTc interval
- Avoid concomitant use of KRAZATI with other products with a
known potential to prolong the QTc interval. Avoid use of KRAZATI
in patients with congenital long QT syndrome and in patients with
concurrent QTc prolongation
- Monitor ECGs and electrolytes prior to starting KRAZATI, during
concomitant use, and as clinically indicated in patients with
congestive heart failure, bradyarrhythmias, electrolyte
abnormalities, and in patients who are taking medications that are
known to prolong the QT interval. Withhold, reduce the dose, or
permanently discontinue KRAZATI, depending on severity
Hepatotoxicity
- KRAZATI can cause hepatotoxicity
- In the pooled safety population, hepatotoxicity occurred in
37%, and 7% were grade 3 or 4. A total of 32% of patients who
received KRAZATI had increased alanine aminotransferase
(ALT)/increased aspartate aminotransferase (AST); 5% were grade 3
and 0.5% were grade 4. Increased ALT/AST leading to dose
interruption or reduction occurred in 11% of patients. KRAZATI was
discontinued due to increased ALT/AST in 0.5% of patients
- Monitor liver laboratory tests (AST, ALT, alkaline phosphatase,
and total bilirubin) prior to the start of KRAZATI, and monthly for
3 months or as clinically indicated, with more frequent testing in
patients who develop transaminase elevations. Reduce the dose,
withhold, or permanently discontinue KRAZATI based on severity
Interstitial Lung Disease /Pneumonitis
- KRAZATI can cause interstitial lung disease (ILD)/pneumonitis,
which can be fatal. In the pooled safety population,
ILD/pneumonitis occurred in 4.1% of patients, 1.4% were grade 3 or
4, and 1 case was fatal. The median time to first onset for
ILD/pneumonitis was 12 weeks (range: 5 to 31 weeks). KRAZATI was
discontinued due to ILD/pneumonitis in 0.8% of patients
- Monitor patients for new or worsening respiratory symptoms
indicative of ILD/pneumonitis (eg, dyspnea, cough, fever). Withhold
KRAZATI in patients with suspected ILD/pneumonitis and permanently
discontinue KRAZATI if no other potential causes of ILD/pneumonitis
are identified
Adverse Reactions
- The most common adverse reactions (≥25%) are nausea, diarrhea,
vomiting, fatigue, musculoskeletal pain, hepatotoxicity, renal
impairment, edema, dyspnea, decreased appetite
Females and Males of Reproductive Potential
- Infertility: Based on findings from animal studies, KRAZATI may
impair fertility in females and males of reproductive
potential
Please see Full Prescribing
Information.
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 evaluating
KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial
as a monotherapy and in combination with other targeted therapies
(FIT-001). For additional information, please visit Kura’s website
at www.kuraoncology.com and follow us on Twitter and LinkedIn.
About Mirati Therapeutics, Inc.
Mirati Therapeutics, Inc. is a commercial stage biotechnology
company whose mission is to discover, design and deliver
breakthrough therapies to transform the lives of patients with
cancer and their loved ones. The company is relentlessly focused on
bringing forward therapies that address areas of high unmet need,
including lung cancer, and advancing a pipeline of novel
therapeutics targeting the genetic and immunological drivers of
cancer. Unified for patients, Mirati’s vision is to unlock the
science behind the promise of a life beyond cancer.
For more information about Mirati, visit us at Mirati.com or
follow us on Twitter, LinkedIn, and Facebook.
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 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.
Mirati’s Forward Looking Statements
This press release includes forward-looking statements regarding
Mirati Therapeutic, Inc.’s (“Mirati”) business, the therapeutic and
commercial potential of KRAZATI® (adagrasib), MRTX1719
(MTA-cooperative PRMT5 inhibitor), MRTX0902 (SOS1 inhibitor), and
MRTX1133 (selective KRASG12D inhibitor), and Mirati’s technologies
and other products in development. Any statement describing
Mirati’s goals, expectations, intentions or beliefs, financial or
other projections, is a forward-looking statement and should be
considered an at-risk statement. Such statements are subject to
certain risks and uncertainties, including those inherent in the
process of discovering, developing and commercializing medicines
that are safe and effective for use as human therapeutics, the
endeavor of building a business around such medicines, and the
proposed acquisition of Mirati by Bristol-Myers Squibb Company.
Mirati’s forward-looking statements also involve assumptions
that, if they never materialize or prove correct, could cause its
results to differ materially from those expressed or implied by
such forward-looking statements. Although Mirati’s forward-looking
statements reflect the good faith judgment of its management, these
statements are based only on facts and factors currently known by
Mirati. As a result, you are cautioned not to rely on these
forward-looking statements. These and other risks concerning
Mirati’s programs are described in additional detail in Mirati’s
annual report on Form 10-K, and most recent Form 10-Q, which are on
file with the Securities and Exchange Commission (the “SEC”) and
available at the SEC’s website (www.sec.gov). These forward-looking
statements are made as of the date of this press release, and
Mirati assumes no obligation to update the forward-looking
statements, or to update the reasons why actual results could
differ from those projected in the forward-looking statements,
except as required by law.
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
Mirati Contacts
Investor Relations: ir@mirati.com
Media Relations: media@mirati.com
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