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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, 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, 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 profile has 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. 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.
 Provides Research & Development Update on IK-930 Program Targeting the Hippo Pathway){kind=link}