Eikon Therapeutics (EIKN) 3rd Annual Guggenheim Healthcare Innovation Conference summary

ESMO updates and clinical operations

• Seven ESMO abstracts covered four programs; more than 1,000 patients enrolled across trials, with clinical, regulatory, safety and data operations conducted internally.

• Programs address advanced breast, prostate, ovarian, lung, melanoma, gastric, colorectal and endometrial cancers.

EIK1001: mechanism, safety and clinical evidence

• EIK1001 is a systemic dual TLR7/8 agonist intended to create a pro-inflammatory environment and expand tumor-reactive T-cell responses, including in patients who do not respond to checkpoint inhibitors.

• Body-surface-area dosing with a capped top dose has been used; after this change, no Grade 3+ cytokine release syndrome (CRS) has occurred in more than 600 treated patients. Grade 1/2 fever and chills occur at low single-digit rates.

• TeLuRide-005 enrolled 72 U.S. patients and found EIK1001 plus pembrolizumab and chemotherapy tolerable; some patients completed two years of triplet therapy.

• In evaluable squamous lung cancer patients, investigator-assessed overall response rate was 72% and disease control rate 100%; duration of response was 12.9 months versus ~7 months typically in cross-study comparisons, with small-study caveats.

EIK1001 development plans

• Seamless Phase II/III studies are underway in melanoma and non-small cell lung cancer (NSCLC); melanoma enrollment has been rapid, and the study passed its first interim dose-collapse review.

• The melanoma study’s next event-driven interim review will assess whether to proceed to Phase III; an independent data monitoring committee evaluates efficacy and safety stopping rules.

• FDA advised that if EIK1001 produces similar response-rate and duration data in the randomized NSCLC study, accelerated approval review should be requested; this route could advance the program by ~1 year versus melanoma, contingent on study results.