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Eikon Therapeutics Announces First Patient Dosed in TeLuRide-008, a Registrational Phase 2/3 Trial of EIK1001 in Non-Small Cell Lung Cancer

EIKN
  • Eikon Therapeutics announced the first patient has been dosed in TeLuRide-008, a Phase 2/3 registrational study.
  • The trial evaluates EIK1001 combined with pembrolizumab & histology-appropriate chemotherapy as first-line therapy for treatment-naïve patients with stage 4 Non-Small Cell Lung Cancer (NSCLC).
  • Roy Baynes, M.D., Ph.D., Chief Medical Officer, stated the current standard of care for NSCLC was established over a decade ago & lacks durable benefit for many patients.
  • EIK1001 is a dual-agonist of Toll-like receptors 7 & 8 designed to stimulate innate & adaptive immunity & recruit a broader T-cell repertoire.
  • TeLuRide-008 is a global, multicenter, double-blind, placebo-controlled, randomized adaptive study with NCT07365319.
  • The study includes two phases (Phase 2 & Phase 3) & three parts: dose optimization, dose expansion, & confirmatory hypothesis testing.
  • Chemotherapy regimens include pemetrexed plus carboplatin or cisplatin for non-squamous histology, & carboplatin plus paclitaxel or nab-paclitaxel for squamous histology.
  • TeLuRide-008 is the second registrational Phase 2/3 trial for EIK1001, following TeLuRide-006 in advanced malignant melanoma which started in May 2025.
  • Over 500 patients have been studied with EIK1001 to date, showing it is well-tolerated as monotherapy & in combination with PD-(L)1 therapy.
  • NSCLC accounts for 80 to 85 percent of all lung cancer cases & often presents at advanced stages with significant unmet medical need.
  • Eikon Therapeutics is a late-stage clinical biopharmaceutical company focused on oncology & utilizing a proprietary single molecule tracking system.
  • The press release includes forward-looking statements regarding therapeutic potential, safety, efficacy, & future milestones subject to risks & uncertainties.