EIK1001

Shows activity

Also known as:

BDB001

Cancer types include:

melanoma non-small cell lung cancer small cell lung cancer

TrialFetch AI Analysis

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Overview

EIK1001, formerly BDB001, is an investigational, intravenously administered small-molecule immunotherapy and dual agonist of Toll-like receptors 7 and 8 (TLR7/8). It is being developed for solid tumors, principally in combination with immune-checkpoint inhibitors and, in non-small-cell lung cancer (NSCLC), chemotherapy. Clinical development includes Phase 2 NSCLC and Phase 2/3 advanced-melanoma studies; no regulatory approval has been reported. (sec.gov)

Mechanism of action

TLR7 activation in plasmacytoid dendritic cells promotes type I interferon signaling and innate immunity, while TLR8 activation stimulates myeloid dendritic cells and antigen presentation, supporting tumor-specific T-cell priming. Systemic intravenous administration is intended to activate immune cells in lymphoid tissues rather than only within injected tumors. Clinical pharmacodynamic studies found increases in interferon-γ, IP-10 and other cytokines consistent with TLR7/8 activation. (eikontx.com)

Efficacy

First-line stage IV NSCLC: In the open-label Phase 2 TeLuRide-005 study, EIK1001 plus pembrolizumab and chemotherapy produced a 61% objective response rate (ORR) and 90% disease-control rate (DCR) among 71 treated patients. ORR was 55.6% in nonsquamous and 68.0% in squamous NSCLC; the respective DCRs were 83.3% and 100%. Because this was a nonrandomized study, the contribution of EIK1001 beyond standard pembrolizumab plus chemotherapy remains uncertain. (ascopubs.org)
Monotherapy, advanced solid tumors: A Phase 1 study reported two partial responses among 32 efficacy-evaluable patients (ORR 6%) and a 62% DCR, including durable responses in renal-cell carcinoma and NSCLC. (jitc.bmj.com)
With pembrolizumab: In Phase 1 dose escalation, four of 14 patients at the two highest dose levels responded (29%), with an overall 57% DCR in that subgroup. (ascopubs.org)
With atezolizumab: A Phase 1 study reported responses in 3/37 patients (ORR 8.1%), a 51.4% DCR, and a median response duration of 13 months. (ascopubs.org)
Pancreatic adenocarcinoma: In the Phase 2 AGADIR study combining BDB001, atezolizumab and stereotactic radiotherapy, central review found partial responses in 2/21 patients (9.5%) and a 38% DCR. (s3.amazonaws.com)

Safety

In TeLuRide-005, 76.1% of patients experienced at least one grade ≥3 treatment-emergent adverse event and 46.5% experienced a serious adverse event; these rates include toxicities from the entire pembrolizumab–chemotherapy combination. Cytokine-release syndrome occurred in seven patients and was limited to grade 1–2. (ascopubs.org)

Earlier Phase 1 monotherapy data showed mostly grade 1–2 events—commonly chills/rigors, fever, fatigue, nausea and pruritus. Grade 3 treatment-related events occurred in 8.3%, including two cases of cytokine-release syndrome; no grade 4–5 treatment-related events were reported. With pembrolizumab, 13% had grade 3 treatment-related events and none had grade 4–5 events. (jitc.bmj.com)

Active trials using EIK1001

Found 3 active trials using this drug:

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).

Sponsor: Eikon Therapeutics (industry) Phase: 2/3 Start date: June 15, 2026

TrialFetch AI summary: Adults with previously untreated stage IV squamous or nonsquamous NSCLC, ECOG 0–1, and no actionable alteration with an approved first-line targeted therapy receive pembrolizumab and histology-appropriate platinum-based chemotherapy plus either EIK1001 or placebo. EIK1001 is an investigational TLR7/8 agonist intended to stimulate innate immune signaling and antigen presentation.

ClinicalTrials.gov ID: NCT07365319

A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants With Advanced Melanoma (TeLuRide-006)

Sponsor: Eikon Therapeutics (industry) Phase: 2/3 Start date: May 22, 2025

TrialFetch AI summary: Adults with previously untreated unresectable stage III or metastatic stage IV melanoma, measurable disease, and ECOG performance status 0–1 receive first-line pembrolizumab plus either placebo or EIK1001. EIK1001 is an investigational intravenous TLR7/8 agonist intended to enhance innate immune activation and tumor-specific T-cell priming.

ClinicalTrials.gov ID: NCT06697301

A Phase 2 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Patients With Stage 4 Non-Small Cell Lung Cancer

Sponsor: Eikon Therapeutics (industry) Phase: 2 Start date: Feb. 6, 2024

TrialFetch AI summary: Adults with untreated stage IV squamous or nonsquamous NSCLC, ECOG 0–1, and no alteration warranting approved first-line targeted therapy receive investigational EIK1001, a TLR7/8 agonist, plus pembrolizumab and carboplatin with paclitaxel (squamous) or pemetrexed (nonsquamous). The study has no standard-of-care-only control arm.

ClinicalTrials.gov ID: NCT06246110