Ikena Oncology Announces FDA Acceptance of IND Application of Novel TEAD Inhibitor IK-930

Rhea-AI Summary

Ikena Oncology announced that the U.S. FDA has accepted its Investigational New Drug (IND) application for IK-930, a TEAD inhibitor targeting genetic alterations in the Hippo pathway. This marks a crucial step towards their first-in-human phase 1 clinical trial, set to begin in early 2022, focusing on patients with solid tumors like NF2-deficient malignant mesothelioma. Ikena aims to evaluate the effectiveness of IK-930, both as a standalone treatment and in combination with other therapies, addressing significant unmet needs in oncology.

Positive

• FDA acceptance of IND for IK-930 is a significant milestone for clinical development.
• Focus on cancers with high unmet medical need, including rare forms of soft tissue sarcoma.
• Preclinical data indicates IK-930 may be effective as a monotherapy and in combination with other agents.

Negative

• None.

Ikena expects to initiate its first-in-human phase 1 clinical trial in early 2022 in patients with solid tumors that harbor genetic alterations across the Hippo pathway

BOSTON, Nov. 02, 2021 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena”), a targeted oncology company navigating new territory in patient-directed cancer treatment, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to study its TEAD inhibitor candidate, IK-930, for the treatment of cancers harboring genetic mutations in the Hippo signaling pathway.

Ikena is developing IK-930 as a potential targeted therapy for patients with cancers that exhibit genetic alterations across the Hippo pathway. IK-930 is designed to selectively bind TEAD and to disrupt TEAD-dependent transcription of key genes involved in cancer progression, metastases, and therapeutic resistance. Preclinical research, including data presented by Ikena at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2021, suggests that IK-930 is a potent and selective TEAD inhibitor that could prove effective both as a monotherapy and in combination with multiple targeted agents, such as EGFR and MEK inhibitors, in multiple hard-to-treat cancers.

“At Ikena, we are committed to redefining the oncology landscape by developing precise targeted therapies that address cancer’s underlying driver mechanisms. The acceptance of our IND for IK-930 by the FDA represents an important step in this ambitious mission and will allow us to evaluate how our promising preclinical data with TEAD inhibition translates into clinical benefit in patients,” said Sergio Santillana, M.D., Chief Medical Officer at Ikena. “We will initially focus our efforts on tumors with frequent genetic alterations in the Hippo pathway, high unmet need, and a potential for meaningful clinical impact. Our biomarker-driven approach will be key in determining which patient populations stand to benefit most from IK-930. We look forward to sharing updates as this clinical program progresses.”

The planned Phase 1 clinical trial includes patients with tumor types with a high frequency of Hippo pathway alterations, including NF2-deficient malignant mesothelioma and some soft tissue sarcomas with YAP/TAZ genetic fusions, including Epithelioid Hemangioendothelioma (EHE), a rare form of soft tissue sarcoma that has a significant unmet medical need with no currently approved therapy for advanced or metastatic disease. As supported by preclinical work, Ikena also plans to explore combinations of IK-930 with other targeted agents for the treatment of solid tumors, such as EGFR-mutant non-small cell lung cancer (NSCLC) and KRAS-mutant solid tumors.

About Ikena Oncology
Ikena 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. Additional programs include an ERK5 inhibitor program targeting the KRAS signaling pathway and programs targeting the tumor microenvironment and immune signals, two of which are being developed in collaboration with Bristol Myers Squibb, including IK-175, an aryl hydrocarbon receptor antagonist designed to modulate the tumor microenvironment. 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.

Media Contact:
Gwen Schanker
LifeSci Communications
gschanker@lifescicomms.com 

Investor Contact:
Rebecca Cohen
Ikena Oncology
rcohen@ikenaoncology.com 

FAQ

What is Ikena Oncology's recent FDA news about IK-930?

Ikena Oncology announced the FDA's acceptance of its IND application for IK-930, allowing them to start a phase 1 clinical trial.

What types of cancer will IK-930 target in the clinical trials?

IK-930 will target solid tumors with genetic alterations in the Hippo pathway, such as NF2-deficient malignant mesothelioma.

When is the phase 1 trial for IK-930 expected to begin?

The first-in-human phase 1 clinical trial for IK-930 is expected to begin in early 2022.

What is the significance of IK-930 in cancer treatment?

IK-930 aims to disrupt TEAD-dependent gene transcription, potentially overcoming resistance in various hard-to-treat cancers.

What are the expected outcomes of the IK-930 trials?

Ikena is evaluating IK-930's effectiveness and its potential for clinical benefit based on promising preclinical data.