Ikena Oncology Receives FDA Fast Track Designation for Novel TEAD Inhibitor IK-930 to Treat Unresectable NF2-Deficient Mesothelioma
June 22 2022 - 7:00AM
Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena”), a targeted oncology
company forging new territory in patient-directed cancer treatment,
today announced that the U.S. Food and Drug Administration (FDA)
has granted Fast Track designation for IK-930, the Company’s novel
TEAD inhibitor targeting the Hippo signaling pathway, in patients
with unresectable NF2-deficient malignant pleural mesothelioma
(MPM).
Fast Track designation granted by FDA facilitates the
development and expedites the review of drugs intended to treat
serious or life-threatening diseases. Features of Fast Track
designation include opportunities for more frequent interactions
with the FDA review team and, if supported by clinical data, the
therapy could potentially be eligible for priority review. Earlier
in 2022, the FDA granted IK-930 Orphan Drug designation, which
supports development of drugs for rare disorders, as a potential
novel therapeutic option for patients with malignant pleural
mesothelioma.
“We are delighted to announce that IK-930 has been granted Fast
Track designation, demonstrating the potential of IK-930 to address
the unmet medical need of people with unresectable NF2-deficient
MPM,” said Sergio Santillana, MD, Chief Medical Officer at Ikena.
“This milestone, combined with the Orphan Drug designation in
mesothelioma, further validates our targeted oncology approach to
address significant unmet medical needs for difficult-to-treat
cancers and supports our goal to advance the development of IK-930
for the patients who potentially could benefit most.”
IK-930 binds to TEAD transcription factors to prevent
transcription of multiple genes in the Hippo pathway that are known
to cause cancer progression. Patients with NF2-deficient malignant
pleural mesothelioma account for approximately 40% of mesothelioma
patients worldwide and are generally treated through a combination
of standard-of-care options, including surgery, chemotherapy,
immunotherapy, and radiation. IK-930 provides a novel targeted
approach to address the underlying biology driven by the genetic
alterations that cause cancer pathogenesis.
IK-930 is currently being studied in a Phase 1 clinical trial as
a monotherapy in patients with advanced solid tumors with or
without gene alterations in the Hippo pathway, including
NF2-deficient malignant mesothelioma, Epithelial
Hemangioendothelioma (EHE) with documented TAZ/CAMTA1 fusion genes
as well as other solid tumors with either NF2 deficiency or with
YAP/TAZ genetic fusions (NCT05228015). Preclinical and
translational data shared at the American Association for Cancer
Research 2022 Annual Meeting highlighted IK-930 as a potential
first-in-class TEAD inhibitor that could address unmet need and
overcome therapeutic resistance.
About Ikena OncologyIkena Oncology™ is
focused on developing novel therapies targeting key signaling
pathways that drive the formation and spread of cancer. The
Company’s lead targeted oncology program, IK-930, is a TEAD
inhibitor addressing the Hippo signaling pathway, a known tumor
suppressor pathway that also drives resistance to multiple targeted
therapies. The Company’s ongoing discovery research spans the Hippo
pathway as well as the RAS signaling pathway. Additional programs
targeting the tumor microenvironment and immune signaling are in
the clinic, including IK-175, an aryl hydrocarbon receptor
antagonist, which is being developed in collaboration with Bristol
Myers Squibb. Ikena’s pipeline is built on addressing genetically
defined or biomarker-driven cancers and developing therapies that
can serve specific patient populations in need of new therapeutic
options. To learn more, visit www.ikenaoncology.com or follow us on
Twitter and LinkedIn.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, implied and express statements
regarding Ikena’s strategy, business plans and focus; and the
progress of the preclinical and clinical development of the
programs in Ikena’s portfolio. The words “may,” “will,” “could,”
“would,” “should,” “expect,” “plan,” “anticipate,” “intend,”
“believe,” “estimate,” “predict,” “project,” “potential,”
“continue,” “target” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based
on management’s current expectations and beliefs and are subject to
a number of risks, uncertainties and important factors that may
cause actual events or results to differ materially from those
expressed or implied by any forward-looking statements contained in
this press release, including, without limitation, those risks and
uncertainties associated with the following: the impact of the
ongoing COVID-19 pandemic on countries or regions in which Ikena
has operations or does business, as well as on the timing and
anticipated results of its clinical trials, strategy and future
operations, the therapeutic potential of Ikena’s product candidates
and the timing and completion of its clinical trials and related
data analyses; positive results from a clinical study may not
necessarily be predictive of the results of future or ongoing
clinical studies, Ikena’s ability to fund its research and
development efforts, and other factors discussed in the “Risk
Factors” section of Ikena’s Annual Report on Form 10-K for the year
ended December 31, 2021, which is on file with the SEC, as
updated by any subsequent SEC filings. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Ikena expressly disclaims any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise.
Investor Contact:Rebecca CohenIkena
Oncologyrcohen@ikenaoncology.com
Media Contact:Gwen SchankerLifeSci
Communicationsgschanker@lifescicomms.com
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