EIK1005
/ Eikon Therap
- LARVOL DELTA
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July 17, 2026
Phase 1/2 Study of the Novel Werner Helicase Inhibitor EIK1005 as Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors, Including MSI-H or dMMR Tumors
(ESMO 2026)
- No abstract available
Clinical • Combination therapy • dMMR • Metastases • Monotherapy • MSI-H • P1/2 data • Microsatellite Instability • Oncology • Solid Tumor • MSI
July 17, 2026
Analysis of the Safety, Tolerability, and PK of EIK1005, a Novel WRN Inhibitor
(ESMO 2026)
- No abstract available
Clinical • Oncology • WRN
July 20, 2026
Eikon Therapeutics Announces…Abstracts Accepted for Presentation at the 2026 European Society of Medical Oncology (ESMO) Congress
(GlobeNewswire)
- "Presentations to cover updates across Eikon’s clinical pipeline including: Phase 1/2 Study of the Novel Werner Helicase Inhibitor EIK1005 as Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors, Including MSI-H or dMMR Tumors; Analysis of the Safety, Tolerability, and PK of EIK1005, a Novel WRN Inhibitor."
Clinical data • dMMR • MSI-H • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Microsatellite Instability
April 21, 2026
Phase 1/2 study of the novel Werner helicase inhibitor EIK1005 as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, including MSI-H or dMMR tumors.
(ASCO 2026)
- P1/2 | "Secondary objectives: preliminary antitumor activity, characterize plasma PK profile of EIK1005 monotherapy and + pembro. This study began in December 2025."
Clinical • Combination therapy • dMMR • Metastases • Monotherapy • MSI-H • P1/2 data • Metabolic Disorders • Microsatellite Instability • Oncology • Solid Tumor • MSI • WRN
April 21, 2026
First-in-human study to evaluate the safety, tolerability, and PK of EIK1005, a novel WRN inhibitor in healthy participants.
(ASCO 2026)
- P1 | "SOC for patients with MSI-H tumors includes surgery and immunotherapy (checkpoint inhibitors [CPIs] such as pembrolizumab [pembro]), however ~30 to 50% of patients do not respond to first-line immune CPIs or acquire resistance. EIK1005 had a favorable safety profile at the 50 and 100 mg single doses evaluated in healthy pts. PK and safety data support a starting dose of 50 mg given in patients in EIK1005-002 (NCT#007262619)."
Clinical • First-in-human • IO biomarker • P1 data • Metabolic Disorders • Microsatellite Instability • Oncology • Solid Tumor • MSI • WRN
May 21, 2026
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
May 18, 2026
EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors
(clinicaltrialsregister.eu)
- P1/2 | N=8 | Not yet recruiting | Sponsor: Eikon Therapeutics Inc.
Checkpoint inhibition • dMMR • Mismatch repair • Monotherapy • MSI-H • New P1/2 trial • Microsatellite Instability • Oncology • Solid Tumor • MSI
May 11, 2026
Clinical Updates:…EIK1005
(GlobeNewswire)
- "The program has advanced into clinical development, with a Phase 1/2 trial underway in patients with advanced solid tumors, which began dosing in February 2026. Two abstracts have been accepted for presentation or publication at the ASCO annual meeting, including data on pharmacokinetics and pharmacodynamics in healthy volunteers and resulting dose modeling, as well as a Trial-in-Progress presentation for the ongoing Phase 1/2 trial."
dMMR • MSI-H • P1 data • PK/PD data • Trial status • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Microsatellite Instability
March 18, 2026
Preclinical development of EIK1005, a potent and selective inhibitor of Werner helicase
(AACR 2026)
- "Further studies elucidated several mechanisms of potential resistance to WRN inhibition. Overall, our preclinical characterization of EIK1005 demonstrates its strong activity and favorable pharmacologic profile that provide impetus to the ongoing clinical development of EIK1005 in patients with MSI-H cancers."
Preclinical • Microsatellite Instability • Oncology • GDF15 • MSI • WRN
March 03, 2026
EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors
(clinicaltrials.gov)
- P1/2 | N=160 | Recruiting | Sponsor: Eikon Therapeutics | Not yet recruiting ➔ Recruiting
Checkpoint inhibition • dMMR • Enrollment open • Mismatch repair • Monotherapy • MSI-H • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI
December 04, 2025
EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors
(clinicaltrials.gov)
- P1/2 | N=160 | Not yet recruiting | Sponsor: Eikon Therapeutics
Checkpoint inhibition • dMMR • Mismatch repair • Monotherapy • MSI-H • New P1/2 trial • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Microsatellite Instability • Oncology • Solid Tumor
October 15, 2025
A novel, internally derived program targeting Werner (WRN) helicase for microsatellite unstable cancers and sensitive cancers that have other defects in DNA repair. EIK1005 is expected to begin Phase 1 clinical testing in Q4, 2025.
(Businesswire)
New P1 trial • Microsatellite Instability • Solid Tumor
October 10, 2025
A Randomized, Double Blind, Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of EIK1005 in Healthy Participants.
(ANZCTR)
- P1 | N=48 | Active, not recruiting | Sponsor: EIKON Therapeutics, Inc. | Not yet recruiting ➔ Active, not recruiting | Initiation date: Aug 2025
Enrollment closed • Trial initiation date • Microsatellite Instability • Solid Tumor
April 18, 2025
A Randomized, Double Blind, Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of EIK1005 in Healthy Participants.
(ANZCTR)
- P1 | N=48 | Not yet recruiting | Sponsor: EIKON Therapeutics, Inc.
New P1 trial • Microsatellite Instability • Solid Tumor
February 26, 2025
Eikon Therapeutics Secures $350.7 Million Series D to Advance Clinical-Stage Programs and Future Pipeline
(Businesswire)
- "Eikon Therapeutics, Inc...announced the initial closing of a $350.7 million Series D financing. Since its founding in 2019, Eikon Therapeutics has privately raised in excess of $1.1 billion to support its mission of developing new medicines to address grievous illnesses....Eikon’s clinical portfolio is anchored by its lead program, EIK1001, a systemically administered co-agonist of toll-like receptors 7 and 8 now in a Phase III trial for advanced melanoma.... In parallel, the company is advancing EIK1003, a highly selective PARP1 inhibitor currently undergoing Phase 1 evaluation in patients with breast, ovarian, prostate, or pancreatic cancers, and EIK1004, a central nervous system-penetrant PARP1-selective inhibitor poised to initiate Phase 1 studies targeting brain cancers. Eikon’s early-stage pipeline features, among other undisclosed candidates, two androgen receptor antagonists and an internally derived WRN inhibitor (EIK1005)..."
Financing • Brain Cancer • Breast Cancer • Melanoma • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer
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