resiquimod sulfate (EIK1001) / Seven and Eight BioPharma, Eikon Therap - LARVOL DELTA

A Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (NSCLC) [TeLuRide-008] (ESMO 2026) - No abstract available

Combination therapy • Metastases • P2/3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

TeLuRide-005: Phase 2 study of EIK1001 (TLR7/8 dual agonist) plus pembrolizumab and chemotherapy in patients with stage IV NSCLC: results from the squamous cohort and updated pooled results. (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TLR7

Immunity induction with atezolizumab, EIK1001, and radiotherapy in virus-associated tumors: Results of the AGADIR Trial (AACR 2025) - "The combination of atezolizumab, EIK1001, and radiotherapy met its primary endpoint of disease control rate at 24 weeks, underscoring the potential of this regimen. in virus-associated tumors, particularly HPV-related cancers. Biomarker analyses support the immunogenic potential of this regimen, suggesting a paradigm shift in treating immunologically 'cold' virus-associated tumors."

IO biomarker • Cervical Cancer • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor

TeLuRide-005: Phase II study of EIK1001, a toll-like receptor 7/8 (TLR7/8) co-agonist with pembrolizumab (pembro)+chemotherapy (chemo) as first-line (1L) therapy in stage 4 non-small cell lung cancer (NSCLC) (ESMO 2025) - P2 | "Methods TeLuRide-005 is an ongoing multicenter, phase II, open-label study of intravenous EIK1001 combined with SOC pembro +chemo (carboplatin plus either pemetrexed or paclitaxel) in treatment-naïve participants (pts) with histologically confirmed Stage 4 nonsquamous (NSQ) or squamous (SQ) NSCLC. Thus far, the improvement with successive scans in a short time on treatment suggests that the efficacy of the combination may be an underestimate at this point. Updated safety and efficacy data will be reported at the time of presentation."

Clinical • Metastases • P2 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TLR7

First in class TLR7/8 agonist BDB001 combined with atezolizumab and stereotactic body radiation therapy in patients with advanced pancreatic adenocarcinoma: Results from the AGADIR study. (ASCO 2023) - P2 | "The AGADIR study met its first endpoint for disease control rate in patients with advanced pancreatic cancer. Efficacy data on the whole cohort of patients and full biomarkers analyses will be presented at the meeting. Clinical trial information: NCT03915678."

Clinical • IO biomarker • Metastases • Gastrointestinal Cancer • Hepatology • Immune Modulation • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • PD-L1

Eikon Therapeutics…announced the selection of a dose of 0.60 mg/m2 that will be employed in future for all patients randomized to receive EIK1001 in the TeLuRide-006 trial (GlobeNewswire) - "This decision aligns with a recommendation from an independent DMC following a prespecified analysis of unblinded data....DMC recommended that the TeLuRide-006 study continue as planned in all other respects."

Trial status • Melanoma

Eikon Therapeutics Announces First Patient Dosed in TeLuRide-008, a Registrational Phase 2/3 Trial of EIK1001 in Non-Small Cell Lung Cancer (GlobeNewswire) - "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."

Trial status • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer

Presentations to cover updates across Eikon’s clinical pipeline including: (GlobeNewswire) - "Updated data from TeLuRide-005, an ongoing Phase 2 trial of EIK1001, a TLR7/8 dual agonist, plus pembrolizumab and chemotherapy in stage 4 non-small cell lung cancer (NSCLC); Updated cohort data from an ongoing Phase 1/2 study of EIK1003, a highly selective non-brain penetrant PARP1 inhibitor, as monotherapy and in combination with chemotherapy in advanced solid tumors; Initial data from a Phase 1/2 study of EIK1003 in combination with the novel hormonal agent abiraterone in metastatic prostate cancer; Initial results from an ongoing Phase 1/2 study of EIK1004, a highly selective CNS-penetrant PARP1 inhibitor in advanced solid malignancies."

Clinical data • Non Small Cell Lung Cancer • Prostate Cancer

EIK1001 Clinical Update. (GlobeNewswire) - "Enrollment completed in the first quarter of 2026...At the March 17, 2026 safety data cutoff, among the safety evaluable population (n=72: 39 non-squamous; 33 squamous), the combination of EIK1001 with pembrolizumab and chemotherapy was generally well tolerated, with an adverse event (AE) profile similar to standard of care alone. Most treatment-emergent adverse events (TEAEs) were Grade 1-2, and the most common Grade 3 or higher treatment-related adverse events...All cytokine release syndrome (CRS) AEs were Grade 1 and 2, and all CRS events occurred before Cycle 4 in all but one patient."

Enrollment closed • P1 data • Non Small Cell Lung Cancer

A phase 2/3 study of EIK1001 in combination with pembrolizumab and chemotherapy in participants with stage 4 non–small cell lung cancer (NSCLC) (TeLuRide-008). (ASCO 2026) - "Secondary objectives: safety and tolerability, ORR and DOR per RECIST v1.1 by BICR. Exploratory objectives: time to response, EIK1001 exposure-response relationships, and health-related quality of life."

Combination therapy • IO biomarker • Metastases • P2/3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Solid Tumor

Adaptive phase 2/3 study of EIK1001, a TLR7/8 dual agonist, in combination with pembrolizumab, as first-line therapy in participants with advanced melanoma (TeLuRide-006). (ASCO 2026) - "Exploratory objectives include time to response, EIK1001 exposure-response relationships, and health-related quality of life. This study enrolled (randomized) its first participant on 5/21/2025 and is activated at 91 sites in 22 countries at the time of abstract submission."

Clinical • Combination therapy • IO biomarker • Metastases • P2/3 data • Cutaneous Melanoma • Interstitial Lung Disease • Melanoma • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • BRAF • TLR7

Efficacy, safety, and cytokine profiling with addition of the toll-like receptor (TLR) 7/8 dual agonist EIK1001 to standard of care (SOC) first-line (1L) therapy: The phase 2 TeLuRide-005 trial in stage 4 NSCLC. (ASCO 2026) - " TeLuRide-005 (NCT#06246110) is an ongoing multicenter, open-label study of intravenous weekly (wk) EIK1001 combined with SOC q3-wk pembro + chemo in treatment-naïve patients (pts) with Stage 4 NSCLC. 1L EIK1001 + SOC demonstrates encouraging efficacy in Stage 4 NSCLC with evidence of durable effect. AEs were similar to SOC alone and CRS events were low-grade. Cytokine data support the MOA of the TLR 7/8 dual agonist, EIK1001, and reduced inducibility of IL6/IL8 PT by C4 may suggest CRS likelihood diminishes with time."

Clinical • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • CXCL8 • IL6

Updated data from our ongoing Phase 2 trial evaluating the safety and tolerability of EIK1001 in combination with both pembrolizumab and histology appropriate chemotherapy for the front-line treatment of patients with advanced NSCLC, also known as our TeLuRide-005 trial… (GlobeNewswire) - "Among the efficacy-evaluable population (n=65: 36 non-squamous; 29 squamous), EIK1001 treatment in combination with pembrolizumab and chemotherapy resulted in a 63.1% objective response rate (ORR) and 90.8% disease control rate (DCR) at the efficacy data cutoff of May 4, 2026. Among participants in the non-squamous cohort, an ORR of 55.6% and a DCR of 83.3% were observed, respectively, with a median follow-up of 13.6 months. The median duration of response (DOR) in the non-squamous cohort was greater than 11 months at the efficacy data cutoff. Among participants in the squamous cohort, for which the data set was still maturing at the data cutoff due to slower enrollment, an ORR of 72.4% and a DCR of 100% were observed, respectively, with a median follow-up of 8.8 months."

P2 data • Non Small Cell Lung Cancer

TeLuRide-005: A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC (clinicaltrials.gov) - P2 | N=70 | Active, not recruiting | Sponsor: Eikon Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

EIK1001-008: A Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer. (clinicaltrialsregister.eu) - P1/2 | N=20 | Not yet recruiting | Sponsor: Eikon Therapeutics Inc.

New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • ROS1

Eikon Therapeutics Announces Availability of Six Abstracts for Presentation at the 2026 Annual Meeting of the American Society of Clinical Oncology (GlobeNewswire) - "Updated data will include those derived from trials of EIK1001, for the treatment of patients with non-small cell lung cancer ('NSCLC'), EIK1003, as a monotherapy or in combination in the treatment of patients with breast, ovarian, prostate, or pancreatic cancer, and EIK1005, which is designed to improve treatment of patients whose tumors demonstrate certain DNA replication abnormalities."

Clinical data • dMMR • MSI-H • P1/2 data • Breast Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer

TeLuRide-008: A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer. (clinicaltrials.gov) - P2/3 | N=750 | Recruiting | Sponsor: Eikon Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • PD-L1 • ROS1

Clinical Updates:…EIK1001 (GlobeNewswire) - "Three abstracts have been accepted for presentation at the American Society of Clinical Oncology ('ASCO') a'nnual meeting, including an updated data set from a now fully enrolled Phase 2 trial evaluating EIK1001 in combination with pembrolizumab and chemotherapy for NSCLC. The updated data set includes a full interim data readout of the non-squamous cohort and a partial interim data readout of the squamous cohort. In addition, we expect to make a Trial-in-Progress presentation to highlight an ongoing Phase 2/3 trial of EIK1001 in combination with pembrolizumab for advanced melanoma, as well as the initiation of a Phase 2/3 trial in combination with pembrolizumab and chemotherapy for stage 4 NSCLC."

P2 data • Trial status • Melanoma • Non Small Cell Lung Cancer

Adaptive phase 2/3 study of EIK1001, a TLR7/8 dual agonist, in combination with pembrolizumab, as first-line therapy in participants with advanced melanoma (Teluride-006) (AACR 2026) - "Exploratory objectives include time to response, EIK1001 exposure-response relationships, and health-related quality of life. This study enrolled (randomized) its first participant on 5/21/2025 and is activated at 89 sites in 22 countries at the time of abstract submission."

Clinical • Combination therapy • IO biomarker • Metastases • P2/3 data • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor • BRAF • TLR7

Pharmacokinetic/biomarker (PK/BMx) analysis of the toll-like receptor 7 and 8 (TLR7/8) agonist EIK1001 in phase 1 studies in participants (Pts) with solid tumors (AACR 2024) - P1 | "This dual activity provides another pathway, distinct from effects on checkpoint proteins, to enhance antitumor T‑cell activity alone or in combination with ICIs. Adults with advanced solid tumors received a range of doses of EIK1001 (QW IV) alone and in combination with pembrolizumab (200 mg Q3W; NCT03486301) or atezolizumab (1200 mg Q3W; NCT04196530) in Phase 1 studies (n=128). The linear, dose-proportional PK of EIK1001 is well described by the Pop-PK model. Increases in IFNγ and IP-10 were consistent with the anticipated mechanism of action, with doses representing target engagement identified. Further development of EIK1001 is underway."

Biomarker • Clinical • IO biomarker • P1 data • PK/PD data • Oncology • Solid Tumor • CXCL8 • IFNG • IL6 • TLR8

A M2-like tumor-associated macrophage-targeted nanoparticulate TLR7/8 agonist, UI-102, reprograms its phenotypes to induce potent anti-tumor immunity (AACR 2026) - "Biodistribution and TAM accumulation were examined in an orthotopic mouse model, comparing UI-102 with resiquimod sulfate and the naked TLR7/8 agonist used in the UI-102 formulation. UI-102 exhibited broad and potent anti-tumor activity across diverse cancer models, correlating with the degree of myeloid/macrophage infiltration in the TME. UI-102 effectively targets and reprograms immunosuppressive TAMs to an M1-like phenotype, thereby unleashing a strong anti-tumor immune response. This unique mechanism positions UI-102 as a promising novel immunotherapeutic agent for a wide range of solid tumors. A first-in-human clinical trial of UI-102 in solid tumors is planned for initiation in Q1 2026."

First-in-human • Oncology • Solid Tumor • CD8

TeLuRide-008: A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer. (clinicaltrials.gov) - P2/3 | N=750 | Not yet recruiting | Sponsor: Eikon Therapeutics

New P2/3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • PD-L1 • ROS1

Eikon Therapeutics to Present New Phase 2 Data on EIK1001 in First-Line Non-Small Cell Lung Cancer at ESMO 2025 (Businesswire) - "Presentation highlights novel TLR7/8 co-agonist in combination with pembrolizumab and chemotherapy in late-stage NSCLC."

P2 data • Non Small Cell Lung Cancer

Safety and efficacy of EIK1003, a selective PARP1 inhibitor, as monotherapy in participants with advanced solid tumors. (ASCO 2025) - "Funded by No funding sources reported Clinical Trial Registration Number: 06253130 Background: PARP inhibitors (PARPi) selectively kill tumor cells with genetic mutations in critical DNA repair genes (eg, BRCA1/2). To date, EIK1001 has demonstrated tolerable safety and encouraging preliminary efficacy. Dose escalation is ongoing. Updated safety and efficacy data will be reported at the time of presentation."

Clinical • Metastases • Monotherapy • Anemia • Breast Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Neutropenia • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HER-2 • HRD • MUC16 • PARP2

TeLuRide-006: An adaptive phase 2/3 study of EIK1001, a Toll-like receptor 7/8 (TLR7/8) agonist, in combination with pembrolizumab in patients with advanced melanoma. (ASCO 2025) - "Exploratory objectives include evaluation of time to objective response, evaluation of potential EIK1001 exposure-response relationships, and evaluation of health-related quality of life, health utilities, and melanoma concerns in pts receiving EIK1001 + pembro relative to placebo + pembro. This study opened on 24 December 2024."

Clinical • Combination therapy • IO biomarker • Metastases • P2/3 data • Interstitial Lung Disease • Melanoma • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • BRAF