MILLBRAE, Calif., July 27, 2026 (GLOBE NEWSWIRE) — Eikon Therapeutics, Inc. (Nasdaq: EIKN) (Eikon), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, today announced that the first patient has been dosed in TeLuRide-008, a Phase 2/3 registrational study evaluating EIK1001 in combination with pembrolizumab and histology-appropriate chemotherapy as first-line therapy for treatment-naïve patients with stage 4 Non-Small Cell Lung Cancer (NSCLC).
“Treating the first patient in TeLuRide-008 is a significant milestone for Eikon as we continue to advance EIK1001 in multiple indications, with the ultimate goal of delivering improved outcomes to patients with significant unmet need,” said Roy Baynes, M.D., Ph.D. Chief Medical Officer of Eikon. “Despite advancements in NSCLC, the current standard of care was established over a decade ago and does not deliver durable benefit for many patients. EIK1001 is designed to drive an enhanced immune response by stimulating both innate and adaptive immunity, improving antigen presentation in secondary lymphoid tissues and recruiting a broader répertoire of T-cells. We are grateful to the patients and investigators participating in this study who are vital partners as we work to develop therapies that may deliver more meaningful and sustained responses for people living with cancer.”
About TeLuRide-008
TeLuRide-008 (NCT07365319) is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered intravenously in combination with pembrolizumab and histology-appropriate chemotherapy to systemic therapy-naïve participants with Stage 4 non-squamous or squamous NSCLC. The specific chemotherapy for non-squamous histology is pemetrexed plus either carboplatin or cisplatin, while for squamous histology it is carboplatin plus paclitaxel or nab-paclitaxel. The study is being conducted in two phases (Phase 2 and Phase 3) and will be analyzed in three parts (dose optimization, dose expansion and confirmatory hypothesis testing). TeLuRide-008 is the second registrational phase 2/3 trial for EIK1001. TeLuRide-006 (NCT06697301), which is enrolling patients with advanced malignant melanoma, was initiated in May of 2025.
About NSCLC
Lung cancer is one of the most common cancers globally, with NSCLC making up 80 to 85 percent of all lung cancer cases. NSCLC is often diagnosed at advanced stages when treatment options are more limited and there remains significant unmet medical need in this patient population. The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The current standard of care for Stage 4 NSCLC combining immune checkpoint inhibitors (ICIs) (e.g., pembrolizumab) plus histology-appropriate chemotherapy confers significant clinical benefit over chemotherapy alone, yet many patients progress nonetheless, highlighting the large unmet medical need in the management of this disease.
About EIK1001
EIK1001 is an investigational, systemically administered dual-agonist of Toll-like receptors 7 and 8 designed to stimulate both innate and adaptive immune responses. In Phase 1 trials of EIK1001, single-agent activity was observed in patients with advanced malignancy. This mechanism may complement the antitumor immune response engendered by PD-(L)1 blockade. EIK1001 has been studied in over 500 patients and observed to be well-tolerated to date, both as a monotherapy, and in combination with PD-(L)1-specific antibody-based therapy.
About Eikon Therapeutics
Eikon is a late-stage clinical biopharmaceutical company dedicated to building a global, fully-integrated organization developing innovative medicines to address serious unmet medical needs. Eikon’s initial focus is oncology, where it is advancing a pipeline of drug candidates targeting areas of high unmet need that could eventually become critical medicines for the treatment of various cancers. Eikon deploys its technology platform, including its proprietary single molecule tracking system, to develop internally-derived novel therapies, while also leveraging the deep expertise of its management team to in-license promising assets. Eikon’s vision is to become a generational leader, by purposefully integrating traditional biology research with advanced engineering to develop better medicines faster. For more information, visit www.eikontx.com.
Forward-Looking/Safe Harbor Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical facts are hereby identified as forward-looking statements for this purpose. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the therapeutic potential, safety, and efficacy of Eikon’s product candidates; the timing for anticipated data readouts; expected milestones and business objectives for 2026 and beyond; and other statements regarding Eikon’s future operations, financial performance, financial position, prospects, objectives, strategies and other future events.
These forward-looking statements are based upon management’s current expectations and assumptions, and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: our limited operating history; our significant net losses incurred since inception and the likelihood of incurring additional losses for the foreseeable future; our need for substantial additional funding; the early stage of development of many of our product candidates and the possibility that our product candidates may fail in development; our dependence on the success of our current product candidates; our ability to leverage our technology platform to enable more informed drug research and development; legal and regulatory risks; intellectual property-related risks; and those risks, uncertainties and other factors discussed under the caption “Risk Factors” and elsewhere in Eikon’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission (“SEC”) on May 11, 2026, and in other public filings with the SEC in the future.
As a result, you should not place undue reliance on any forward-looking statements. The forward-looking statements made in this press release speak only as of the date of this press release, and Eikon undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by law.
Contacts:
Investors
Alfred “Freddie” Bowie, Ph.D., CFO
[email protected]
Media
Colin Sanford
[email protected]
