Eyes will be on Eikon’s upcoming data readout for its toll-like receptors 7 and 8 (TLR7/8) co-agonist, as the company looks to buck the trend of recent clinical trial failures with candidates that target the same proteins.
Eikon is developing EIK1001 as a systemic first-line combination treatment in advanced non-small cell lung cancer (NSCLC), setting its sights on pivotal Phase II/III trial initiation.
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The ongoing open-label Phase II trial (NCT06246110) is investigating the safety and efficacy of EIK1001 in combination with standard of care (SoC) Keytruda (pembrolizumab) and chemotherapy. The trial is enrolling patients with Stage IV non-squamous NSCLC with no prior systemic therapy for advance disease.
Eikon Therapeutics will share data from this study in a mini oral session at the upcoming European Society for Medical Oncology (ESMO) Congress held from 17-21 October in Berlin, Germany.
Positive results for this TLR7/8 co-agonist would buck the trend of a succession of clinical trial failures for other drug candidates with the same targets. By contrast to EIK1001, previous studies have tended to investigate treatments with local subcutaneous administration.
The US-based biopharma did not reveal data from the study but highlighted plans to initiate pivotal trial testing.
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By GlobalDataEikon’s chief medical officer, Roy Baynes, said: “These results, reviewed in a successful end-of-Phase-II meeting with the US Food and Drug Administration (FDA) earlier this year, support the continued advancement of this programme into a registration-enabling Phase II/III trial.”
EIK1001, a co-agonist of TLR7/8, functions by stimulating myeloid and plasmacytoid dendritic cells to activate innate and adaptive immune responses, via systemic administration. According to Eikon, EIK1001 is designed to provide direct anti-tumour activity as well as enhanced T-cell activation to complement co-delivered checkpoint inhibitors. These immunomodulatory effects are postulated to help overcome immune resistance frequently seen in advanced NSCLC.
Despite several therapies winning approval in NSCLC in recent years, there is still unmet need in patients with advanced forms of the disease. Multi-mechanistic drug resistance also poses additional challenges. For checkpoint inhibitors, for example, the proportion of patients with NSCLC patients who have acquired resistance is reported to be up to >60%, according to a paper published in Cancer Cell.
EIK1001’s use beyond lung cancer
Further to the study in advanced NSCLC, EIK1001 has been investigated for various other oncology indications. Currently, there are three additional ongoing clinical trials for EIK1001, previously known as BDB001 (NCT06697301, NCT03915678 and UK-based ISRCTN12459436). This includes a Phase II/III trial for EIK1001 in combination with SoC treatment as first-line therapy for advanced melanoma, which initiated in March 2025.
Eikon Therapeutics secured $350.7m in funding back in February 2025 to progress it’s portfolio of oncology candidates.
