- TeLuRide-005, a Section 2 trial of EIK1001 in first-line sufferers with stage 4 NSCLC accomplished enrollment of each non-squamous and squamous cohorts and reviews up to date charges of response and illness management, strengthening the case for continued growth
- Section 1/2 trial of EIK1003 reviews up to date security and efficacy monotherapy knowledge and preliminary mixture knowledge with weekly paclitaxel in sufferers with superior stable tumors
MILLBRAE, Calif., Could 30, 2026 (GLOBE NEWSWIRE) — Eikon Therapeutics, Inc. (Nasdaq: EIKN) (Eikon), a late-stage scientific biopharmaceutical firm devoted to creating modern medicines to handle severe unmet medical wants, at this time introduced shows on a number of of its lead packages at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, together with up to date knowledge for its EIK1001 trial in non-small cell lung most cancers (NSCLC) and its extremely selective PARP1 inhibitor EIK1003.
“We’re happy to current six abstracts at ASCO reflecting each the progress of our pipeline and the rising physique of proof supporting our lead packages,” stated Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon. “In our most superior program, EIK1001 demonstrated encouraging response charges and sturdiness together with customary of care in first-line NSCLC. We additionally noticed significant scientific exercise of EIK1003 each as a monotherapy and, probably a primary for the discipline, together with paclitaxel, together with responses in closely pretreated sufferers. Collectively, these knowledge proceed to strengthen the scientific rationale behind our packages and their potential to ship significant profit to individuals dwelling with most cancers.”
EIK1001 Clinical Replace.
Up to date knowledge from our ongoing Section 2 trial evaluating the security and tolerability of EIK1001 together with each pembrolizumab and histology applicable chemotherapy for the front-line therapy of sufferers with superior NSCLC, also called our TeLuRide-005 trial, present proof of a probably sturdy impact of EIK1001 together with customary of care, and a preliminary tolerability profile supportive of systemic administration in an out-patient setting, a possible key differentiator of EIK1001 from earlier TLR7/8 focused therapies.
EIK1001 is an investigational, systemically administered dual-agonist of Toll-like receptors 7 and eight designed to stimulate each innate and adaptive immune responses. In Section 1 trials of EIK1001, single-agent exercise was noticed in sufferers with superior malignancy. This mechanism could complement the antitumor immune response engendered by PD-(L)1 blockade.
TeLuRide-005 is our multicenter, open-label trial of once-weekly (QW) systemically administered EIK1001 together with customary of care, as soon as each third week (Q3W) pembrolizumab and histology applicable chemotherapy in first-line, treatment-naïve sufferers with stage 4 NSCLC. Enrollment accomplished in the first quarter of 2026.
As of enrollment cutoff, 72 individuals with beforehand untreated stage 4 NSCLC obtained intravenous EIK1001 QW mixed with customary of care pembrolizumab plus chemotherapy Q3W. After 8 cycles, EIK1001 administration was decreased to Q3W. The utmost therapy length is 2 years (as much as 35 cycles) for EIK1001 together with pembrolizumab, with pemetrexed continued at the discretion of the Investigator for non-squamous sufferers.
At the March 17, 2026 security knowledge cutoff, amongst the security evaluable inhabitants (n=72: 39 non-squamous; 33 squamous), the mixture of EIK1001 with pembrolizumab and chemotherapy was usually properly tolerated, with an opposed occasion (AE) profile much like customary of care alone. Most treatment-emergent opposed occasions (TEAEs) had been Grade 1-2, and the commonest Grade 3 or larger treatment-related opposed occasions (TRAEs) had been neutropenia (30.6%), anemia (9.7%), and thrombocytopenia (9.7%). All cytokine launch syndrome (CRS) AEs had been Grade 1 and a couple of, and all CRS occasions occurred earlier than Cycle 4 in all however one affected person. This profile was ample to assist administration in an out-patient setting throughout the ongoing trial.
Amongst the efficacy-evaluable inhabitants (n=65: 36 non-squamous; 29 squamous), EIK1001 therapy together with pembrolizumab and chemotherapy resulted in a 63.1% goal response fee (ORR) and 90.8% illness management fee (DCR) at the efficacy knowledge cutoff of Could 4, 2026. Amongst individuals in the non-squamous cohort, an ORR of 55.6% and a DCR of 83.3% had been noticed, respectively, with a median follow-up of 13.6 months. The median length of response (DOR) in the non-squamous cohort was better than 11 months at the efficacy knowledge cutoff. Amongst individuals in the squamous cohort, for which the knowledge set was nonetheless maturing at the knowledge cutoff on account of slower enrollment, an ORR of 72.4% and a DCR of 100% had been noticed, respectively, with a median follow-up of 8.8 months.
EIK1003 Clinical Replace.
Up to date knowledge from EIK1003-001, our Section 1/2 trial evaluating the security and efficacy of EIK1003 as monotherapy or together with anti-cancer brokers in individuals with superior stable tumors, reveal that EIK1003 monotherapy (Cohort 1A) was usually well-tolerated throughout a number of dose ranges. In Cohort 1C, indicators of antitumor exercise had been noticed with EIK1003 together with weekly paclitaxel, with a mixture security profile in line with paclitaxel’s recognized toxicities. These knowledge assist what seems to be a singular profile for EIK1003 together methods inside the evolving PARP inhibitor panorama.
EIK1003 is an investigational, highly-selective PARP1 inhibitor designed to depart PARP2 signaling intact. PARP2 inhibition could also be a key driver of the hematological toxicity related to first era, non-selective PARP inhibitors.
Cohort 1A: Up to date EIK1003 Monotherapy Data
As of the enrollment cutoff, 65 sufferers with breast, ovarian, prostate, or pancreatic most cancers have been handled in Cohort 1A with EIK1003 monotherapy at doses starting from 10mg to 160mg as soon as day by day (QD), utilizing a Bayesian optimum interval dose-escalation design to evaluate for security, tolerability, pharmacokinetics and antitumor exercise. This represents an growth of the dataset beforehand offered at ASCO 2025, with further sufferers enrolled and longer follow-up.
At the February 27, 2026 security knowledge cutoff, the up to date security profile in Cohort 1A remained usually in line with knowledge beforehand offered at ASCO 2025. Therapy-emergent opposed occasions (TEAEs) had been reported in 63 of 65 sufferers (96.9%). Grade 3 or larger TEAEs occurred in 29 sufferers (44.6%); the commonest had been anemia (9.2%), neutropenia (7.7%), and ascites (7.7%). 4 of the 6 sufferers who developed Grade 3 or larger anemia had Grade 1-2 anemia at research entry. TEAEs led to dose reductions in 7 sufferers (10.8%) and to therapy discontinuation in 6 sufferers (9.2%). No TRAEs resulting in dying had been reported.
Amongst efficacy-evaluable sufferers in Cohort 1A (n=49), ORR was 14.3% general and 26.7% in PARP-naïve sufferers. Goal responses by tumor sort had been 14.8% (4/27) in ovarian most cancers, 12.5% (2/16) in breast most cancers, and one affected person with prostate most cancers. Median length of response amongst confirmed responders (n=5) was 7.8 months at the efficacy knowledge cutoff of Could 4, 2026.
Cohort 1C: Preliminary Data on EIK1003 in Mixture with Weekly Paclitaxel
As of the February 27, 2026 security knowledge cutoff, 60 sufferers with platinum-resistant ovarian most cancers or HER2-negative breast most cancers that failed chemotherapy or hormonal remedy have been handled in Cohort 1C with EIK1003 at doses starting from 10mg to 60mg QD together with paclitaxel 80 mg/m2 IV QW. Dose-limiting toxicities of febrile neutropenia and tachycardia had been reported in a single affected person every at the highest dose stage examined, 60mg. TEAEs had been reported in 60 out of 60 sufferers (100%). Grade 3 or larger TEAEs occurred in 45 sufferers (75%); the commonest had been neutropenia (50%) and anemia (13.3%). Neutropenia is a recognized and anticipated opposed occasion related to weekly paclitaxel chemotherapy. All 8 sufferers who developed Grade 3 or larger anemia had Grade 1-2 anemia at research entry. TEAEs led to dose reductions in 15 sufferers (25%) and discontinuation of one or each research medicine in 11 sufferers (18.3%). No TRAEs resulting in dying had been reported.
Amongst efficacy-evaluable sufferers in Cohort 1C (n=53), ORR was 24.5%; 12 of 13 responders (92%) had obtained prior taxane remedy. Goal responses by tumor sort had been 29.6% (8/27) in platinum-resistant ovarian most cancers and 19.2% (5/26) in breast most cancers. Period of response amongst confirmed responders (n=9) ranged from 1.5 to 11.4 months, with responses ongoing in 3 responders at the efficacy knowledge cutoff of Could 4, 2026.
2026 ASCO Summary Titles.
EIK1001
Title: Efficacy, security and cytokine profiling with addition of the toll-like receptor (TLR) 7/8 twin agonist EIK1001 to Normal of Care First-Line Remedy: the Section 2 TeLuRide-005 trial in Stage 4 Non-Small Cell Lung Most cancers
Title: Adaptive Section 2/3 Examine of EIK1001, a TLR7/8 Twin Agonist, in Mixture with Pembrolizumab, as First-Line Remedy in Members with Superior Melanoma (TeLuRide-006)
Title: A Section 2/3 Examine of EIK1001 in Mixture with Pembrolizumab and Chemotherapy in Members with Stage 4 Non-Small Cell Lung Most cancers (TeLuRide-008)
EIK1003
Title: EIK1003, a PARP1-selective inhibitor, together with paclitaxel (PTX): Preliminary mixture and up to date monotherapy outcomes from a Section 1/2 research EIK1003-001 in superior stable tumors
EIK1005
Title: First-in-Human Examine to Consider the Security, Tolerability, and PK of EIK1005, a Novel WRN Inhibitor in Wholesome Members
Title: Section 1/2 Examine of the novel Werner helicase inhibitor EIK1005 as Monotherapy and in Mixture with Pembrolizumab in Sufferers with Superior Strong Tumors, together with MSI-H or dMMR Tumors (Publication solely)
Copies of the 2026 ASCO shows might be made obtainable on our web site: www.eikontx.com beneath Scientific Papers & Publications.
About Eikon Therapeutics
Eikon is a late-stage scientific biopharmaceutical firm devoted to constructing a world, fully-integrated group creating modern medicines to handle severe unmet medical wants. Eikon’s preliminary focus is oncology, the place it’s advancing a pipeline of drug candidates concentrating on areas of excessive unmet want that might finally develop into vital medicines for the therapy of numerous cancers. Eikon deploys its expertise platform, together with its proprietary single molecule monitoring system, to develop internally-derived novel therapies, whereas additionally leveraging the deep experience of its administration group to in-license promising property. Eikon’s imaginative and prescient is to develop into a generational chief, by purposefully integrating conventional biology analysis with superior engineering to develop higher medicines sooner. For extra info, go to www.eikontx.com.
Ahead-Trying/Protected Harbor Statements
This press launch comprises forward-looking statements inside the that means of the “secure harbor” provisions of the Personal Securities Litigation Reform Act of 1995. All statements on this press launch that aren’t historic details are hereby recognized as forward-looking statements for this function. These statements could also be recognized by phrases comparable to “goals,” “anticipates,” “believes,” “might,” “estimates,” “expects,” “forecasts,” “purpose,” “intends,” “could,” “plans,” “doable,” “potential,” “seeks,” “will” and variations of these phrases or comparable expressions which might be supposed to determine forward-looking statements, though not all forward-looking statements comprise these phrases. Ahead-looking statements on this press launch embody, however aren’t restricted to, statements relating to: the therapeutic potential, security, and efficacy of Eikon’s product candidates; the timing for anticipated knowledge readouts; anticipated milestones and enterprise aims for 2026 and past, together with Eikon’s anticipated shows at the ASCO Annual Meeting; and different statements relating to Eikon’s future operations, monetary efficiency, monetary place, prospects, aims, methods and different future occasions.
These forward-looking statements are primarily based upon administration’s present expectations and assumptions, and are topic to a quantity of dangers, uncertainties and different elements that might trigger precise outcomes and occasions to vary materially and adversely from these indicated by such forward-looking statements together with, amongst others: our restricted working historical past; our important web losses incurred since inception and the probability of incurring further losses for the foreseeable future; our want for substantial further funding; the early stage of growth of many of our product candidates and the risk that our product candidates could fail in growth; our dependence on the success of our present product candidates; our capacity to leverage our expertise platform to allow extra knowledgeable drug analysis and growth; authorized and regulatory dangers; mental property-related dangers; and people dangers, uncertainties and different elements mentioned beneath the caption “Threat Components” and elsewhere in Eikon’s Quarterly Report on Type 10-Q for the quarter ended March 31, 2026, filed with the Securities and Trade Fee (“SEC”) on Could 11, 2026, and in different public filings with the SEC in the future.
Because of this, you shouldn’t place undue reliance on any forward-looking statements. The forward-looking statements made on this press launch communicate solely as of the date of this press launch, and Eikon undertakes no obligation to replace such forward-looking statements, whether or not consequently of new info, future developments or in any other case, besides as required by regulation.
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