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Completed integration of Toll-Like Receptor 7 and 8 co-agonist programs and is advancing these programs through regulatory interactions
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Selective PARP1 inhibitor asset has been granted Investigational New Drug (IND) c******** for Phase 1 studies
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Brain-penetrant selective PARP1 inhibitor will enter IND-enabling studies by year-end
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Preclinical pipeline expands to include programs targeting steroid hormone receptors, WRN inhibition, and VCP modulation
Eikon Therapeutics, which advances breakthrough therapeutics through the purposeful integration of engineering and science, announced that it has completed the previously announced integration of TLR 7 and 8 co-agonists into its clinical development program, and that it expects to discuss the further development of these molecules with the U.S. Food and Drug Administration (FDA) in the fourth quarter. Separately, the FDA has cleared IMP1734, a highly selective PARP1 inhibitor developed in partnership with Impact Therapeutics, for Phase 1 study initiation, which will also begin in the fourth quarter.
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“Powered by the contributions of our cross-disciplinary organization, Eikon has made important progress in both our early- and clinical-stage pipeline programs”
“Powered by the contributions of our cross-disciplinary organization, Eikon has made important progress in both our early- and clinical-stage pipeline programs,” said Roger M. Perlmutter, M.D., Ph.D., CEO and Board Chair of Eikon Therapeutics. “Our advanced analytical tools have enabled Eikon to capitalize on near-term opportunities to bring new medicines to patients. Irrespective of the precise source of chemical leads, Eikon’s projects employ pioneering protein dynamics visualization systems, coupled with advanced, ML-based, data analysis platforms. These systems, together, are fueling our growth.”
Eikon’s most advanced candidate, BDB001, a systemically administered TLR 7 and 8 co-agonist, has been studied in nearly 300 patients with treatment-resistant advanced malignancies, and has demonstrated clinical activity both as a single agent and in combination with PD-(L)1 inhibitors. Eikon believes that adverse experiences associated with BDB001 treatment are manageable using Eikon’s proposed clinical dosing regimen.
Separately, in collaboration with Impact Therapeutics, Eikon is advancing IMP1734, a novel, highly potent, PARP1 inhibitor that shows profound biochemical and cellular selectivity versus PARP2, a related enzyme that is thought to contribute disproportionately to the adverse effect profiles of currently marketed PARP1/2 inhibitors. The extraordinary selectivity of IMP1734 for PARP1 supports clinical study of this agent as monotherapy and in combination with other treatment regimens. Eikon anticipates initiating Phase 1 clinical studies of IMP1734 in the United States and other jurisdictions in the fourth quarter. In addition, Eikon and Impact Therapeutics have together planned initiation of IND-enabling studies for a brain-penetrant PARP1 candidate that will enter Phase 1 clinical trials once these IND-enabling studies are successfully completed and reviewed.
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“The continued progress of our clinical-stage programs is a testament to our emerging clinical development organization which includes experienced industry professionals who collectively have contributed to more than 100 U.S. regulatory approvals of new medicines over their careers,” said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon Therapeutics. “The recent IND c******** for our lead selective PARP1 inhibitor, and the planned initiation of IND-enabling studies of the brain penetrant molecule, further advance the strategic investments we have made in these unique oncology therapeutics and add to our oncology programs exploring the TLR 7 and 8 co-agonist.”
Eikon has applied its proprietary technologies to programs spanning oncology, immunology, and neuroscience at various stages of preclinical development. Among these programs are candidates targeting steroid hormone receptors, WRN inhibition, and VCP modulation. Eikon has also begun lead optimization of androgen receptor antagonists that target increasingly common androgen receptor mutants, with the aim of delivering a therapeutic for treatment-refractory, castrate-resistant prostate cancer.
“The growth of our preclinical discovery programs is benefiting significantly from the engineering and automation that powers our pioneering, single molecule tracking-based, discovery platform. With the ability to capture upwards of one hundred thousand protein trajectories in less than a second, we are now analyzing more than one million experimental conditions per month,” said Dan Anderson, Ph.D., Chief Scientific Officer of Eikon Therapeutics. “Through AI and machine learning, we are able to rapidly analyze data and inventory molecular interactions with extraordinary scale and precision to support progress across all our drug discovery programs.”
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