Eikon becomes a pivotal-stage biotech
Armed with last year's $106m series C financing, and after a series B brought in a massive $518m in 2022, Eikon Therapeutics is now a pivotal-stage biotech company. A new clinicaltrials.gov listing has revealed that the US group's lead project, the TLR7/8 agonist EIK1001, has started the phase 2/3 Keynote-G04 trial in combination with Keytruda in first-line melanoma. The 740-patient study uses the standard of care, Keytruda monotherapy, as active control, and measure PFS, OS and response rate as primary efficacy endpoints. Keytruda's registrational Keynote-06 study suggests that the numbers for the EIK1001 combo to beat are mOS of 32.7 months, mPFS of 8.4 months and ORR of 42%, though these are now rather old. The Keynote-G04 entry makes no mention about the data being cut according to PD-L1 expression, but patients must be tested for their BRAF V600 mutation status. OncologyPipeline suggests that EIK1001 is the industry's most advanced TLR7/8 agonist, and the mechanism has also been used as an ADC payload. Eikon's pipeline also includes the PARP1 inhibitor EIK1003, which entered phase 1 a year ago; this mechanism has seen buy-in from AstraZeneca and Gilead, and forms a key focus for the private company Nerviano.
Keynote-G04 trial summary
| Active cohort | Control | Setting | Primary endpoints |
|---|---|---|---|
| EIK1001 dose 1 + Keytruda | Keytruda | 740 melanoma patients with known BRAF V600 status, naive to systemic treatment in the metastatic setting (prior adjuvant treatment, incl with PD-(L)1 MAbs or BRAF/MEK inhibitors, is allowed) | PFS, OS, ORR, adverse events |
| EIK1001 dose 2 + Keytruda |
Source: clinicaltrials.gov.
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