On October 15, 2025 Eikon Therapeutics, Inc., a late-stage clinical biopharmaceutical company dedicated to integrating advanced engineering with cutting-edge laboratory and in silico research to accelerate drug discovery, reported that new data from an ongoing Phase 2 study of EIK1001 (TeLuRide-005) will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place in Berlin, Germany from October 17-21, 2025.

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The presentation, titled "TeLuRide-005: Phase II study of EIK1001, a toll-like receptor 7/8 (TLR7/8) co-agonist with pembrolizumab (pembro)+chemotherapy (chemo) as first-line (1L) therapy in stage 4 non-small cell lung cancer (NSCLC)", will be delivered by Richard J. Gralla, M.D., Albert Einstein College of Medicine, during the Mini Oral Session 2 (1850MO – NSCLC metastatic) on Monday, October 20 at 10:55AM CEST.

"EIK1001 represents a unique approach to stimulating the immune system, and we are encouraged by its potential to improve outcomes for patients with advanced non-small cell lung cancer," said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon Therapeutics. "By combining a systemically administered TLR7/8 co-agonist with standard-of-care pembrolizumab and chemotherapy, our goal is to broaden immune activation and enhance anti-tumor responses in this hard-to-treat population. These results, reviewed in a successful end-of-Phase-2 meeting with the FDA earlier this year, support the continued advancement of this program into a registration-enabling Phase 2/3 trial. We look forward to sharing these data at ESMO (Free ESMO Whitepaper)."

TeLuRide-005 (NCT06246110) is a Phase 2 study evaluating EIK1001 in combination with pembrolizumab (KEYTRUDA) and histology-appropriate chemotherapy (carboplatin plus either pemetrexed or paclitaxel) in patients with Stage 4 NSCLC. By stimulating a broad immune response through TLR7/8 co-activation, EIK1001 is designed to enhance T-cell recognition and tumor killing, potentially overcoming immune resistance often observed in advanced NSCLC. The molecule is designed to activate innate and adaptive immunity, providing both direct anti-tumor activity and complementary effects when used in combination with checkpoint inhibitors. The trial’s primary objective is to evaluate the safety and tolerability of EIK1001 in the triplet combination. In addition, Eikon hopes to explore whether the immunomodulatory mechanism of EIK1001 might improve lung cancer treatment regimens. EIK1001 is also being studied in a seamless Phase 2/3 trial (TeLuRide-006; NCT06697301) evaluating its addition to standard-of-care pembrolizumab for the treatment of patients with advanced melanoma.

"The data being presented at ESMO (Free ESMO Whitepaper) mark another step forward for EIK1001 and underscore the increasing momentum across our oncology portfolio," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer of Eikon Therapeutics. "This progress reflects the deep expertise of our team in advancing groundbreaking cancer therapies through clinical development, and we are eager to build on this foundation as we work to deliver important new medicines that address grievous illnesses."

Eikon is also advancing a portfolio of differentiated oncology programs, including both mid-stage clinical assets and internally derived candidates informed by the company’s proprietary single-molecule tracking (SMT) platform. They include:

EIK1003-001 (NCT06253130): A highly selective non-CNS-penetrant PARP1 inhibitor, currently being evaluated in a Phase 1/2 study of adults with advanced solid tumors. Initial pharmacokinetic, safety, tolerability, and early efficacy findings from the monotherapy dose-escalation cohort were reported at ASCO (Free ASCO Whitepaper) 2025.
EIK1004-001 (NCT06907043): A CNS-penetrant PARP1 inhibitor currently in a Phase 1/2 study assessing safety, pharmacokinetics/pharmacodynamics, and preliminary antitumor activity in patients with advanced solid tumors, including those with brain metastases.
EIK1005: A novel, internally derived program targeting Werner (WRN) helicase for microsatellite unstable cancers and sensitive cancers that have other defects in DNA repair. EIK1005 is expected to begin Phase 1 clinical testing in Q4, 2025.

(Press release, Eikon Therapeutics, OCT 15, 2025, View Source [SID1234656685])