Ikena Oncology Provides Research & Development Update on IK-930 Program Targeting the Hippo Pathway

2022-10-18

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Clinical collaboration with AstraZeneca announced for the evaluation of osimertinib in combination with IK-930 for patients with EGFR-mutant lung cancers Company shares further detail on the differentiators of IK-930, a TEAD-paralog selective inhibitor BOSTON, Oct. 18, 2022 (GLOBE NEWSWIRE) -- Ikena Oncology, Inc. (Nasdaq: IKNA, “Ikena”), a targeted oncology company forging new territory in patient-directed cancer treatment, today provided a research & development update on the Company’s lead targeted oncology program in TEAD inhibition. Ikena also announced a clinical trial collaboration agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for the evaluation of TAGRISSO® (osimertinib), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in combination with Ikena’s IK-930 as treatment for patients with EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). TEAD consists of a family of transcription factors that is comprised of multiple paralogs, variations of the same gene with slightly different functions. IK-930 is a paralog-selective TEAD inhibitor designed to maximize both efficacy and safety and is currently being studied as a monotherapy in a first-in-human Phase 1 clinical trial in patients with advanced solid tumors (NCT05228015), including NF2-deficient malignant mesothelioma NF2-deficient malignant mesothelioma, for which the FDA granted Fast Track designation earlier this year. “Patients with Hippo-altered cancers are in need of therapies that are effective, safe, and significantly improve their quality of life. IK-930 is specifically designed as a paralog-selective TEAD inhibitor that has the potential to provide patients with a differentiated treatment option,” said Mark Manfredi, PhD, Chief Executive Officer of Ikena. “As a first in its class, IK-930’s selectivity pro potential to distinguish itself not only as a monotherapy, but in combination with other targeted therapies where resistance has emerged. I am thrilled AstraZeneca shares in this vision and that we will be exploring IK-930 in combination with osimertinib.” The ongoing IK-930 clinical trial has planned cohorts exploring combinations with targeted therapies in which treatment-induced activation of the Hippo pathway may drive resistance. The first combination cohort will be evaluating IK-930’s potential to overcome resistance to EGFR inhibitors EGFR inhibitors. In EGFRm NSCLC, only 50% of patients who develop resistance to osimertinib have potentially identifiable and actionable mechanisms with available therapies, leaving 50% without clear treatment options, representing a significant unmet need. Preclinical results demonstrate that IK-930 combined with osimertinib results in increased induction of apoptosis and improved anti-tumor activity in multiple EGFRm tumor models. This benefit is mediated in part by the Hippo pathway’s role in the proliferation of persister cells, a subpopulation of cancer cells that drive EGFR resistance through TEAD-mediated induction of genes involved in cell cycle re-entry, DNA replication and apoptosis avoidance. Under the clinical trial collaboration agreement AstraZeneca will provide Ikena with osimertinib non-exclusively for evaluation in combination with IK-930 in patients with EGFRm resistant NSCLC. “Expanding the number of patients that could benefit from targeted oncology treatments is an important goal for our team. We believe that targeted oncology has incredible potential as a monotherapy for a portion of patients as well as in combination for patients that experience therapeutic resistance. By understanding the mechanism in which cancers resist therapies, we can create combination regimens that block key compensatory survival pathways,” commented Jeffrey Ecsedy, PhD, Chief Development Officer of Ikena. “The Hippo pathway is implicated in therapeutic resistance to multiple therapies, including osimertinib. Working with AstraZeneca will allow us to investigate how IK-930 could benefit patients with EGFR mutated cancers who have had difficulty responding to current treatments alone and demonstrate how combination with IK-930 could potentially enable deeper and prolonged anti-tumor responses.” Ikena Oncology continues to remain focused on developing therapies that target the underlying mechanisms driving cancer survival and growth through an integrated approach leveraging translational science, drug discovery and cancer biology to address unmet patient needs. Further data on the effectiveness and differentiation of IK-930 in multiple animal models both as a monotherapy and in combination with other targeted therapies will be presented at upcoming conferences, and initial clinical data from the first in human Phase 1 study are expected in 2023. About IK-930 IK-930 is an oral, paralog-selective TEAD inhibitor targeting the Hippo signaling pathway. IK-930 binds to TEAD transcription factors and prevents transcription of multiple genes that drive cancer progression. By targeting the Hippo pathway, a key driver of cancer pathogenesis that is genetically altered in approximately 10% of all cancer types, IK-930 could have a differentiating impact across many cancers with high unmet need. Ikena is advancing IK-930 both as a monotherapy in patients with Hippo pathway mutated cancers and in combination with other approved targeted therapies to combat therapeutic resistance. 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 NF2-deficient malignant mesothelioma, Epithelioid 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). About Ikena Oncology Ikena OncologyTM 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 other targets in 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 AHR 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 or follow us on Twitter and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding: the timing and advancement of our targeted oncology programs, including the timing of updates; our expectations regarding the therapeutic benefit of our targeted oncology programs; our ability to efficiently discover and develop product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the implementation of our business model, and strategic plans for our business and product candidates. 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 related to the timing and advancement of our targeted oncology programs; our expectations regarding the therapeutic benefit of our targeted oncology programs; expectations regarding our new executive officer; our ability to efficiently discover and develop product candidates; the implementation of our business model, and strategic plans for our business and product candidates, and other factors discussed in the “Risk Factors” section of Ikena’s Form 10-Q for the quarter ended June 30, 2022, which is on the SEC, as updated by any subsequent SEC filings. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. Investor Contact: Rebecca Cohen Ikena Oncology rcohen@ikenaoncology.com Media Contact: Gwen Schanker LifeSci Communications gschanker@lifescicomms.com