ILKN421H / iLeukon Therapeutics - LARVOL DELTA

ILKN421H Plus Pembrolizumab in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: iLeukon Therapeutics, Inc. | 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 • PD-L1

A first-in-human (FIH), phase I/II open-label, dose-escalation and -expansion study of ILKN421H, an LNP mRNA encoding an IL2Rβγ selective IL-2v, as monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors. (ASCO 2026) - P1/2 | "ILKN421H was generally well tolerated at the current dose level, which already demonstrated high and prolonged plasma level of IL-2, and robust immune stimulatory activity in promoting CD8 T cells and NK cells proliferation. Initial signs of antitumor efficacy were seen in combination with pembrolizumab. Clinical trial information: NCT05978102."

Clinical • Combination therapy • First-in-human • IO biomarker • Metastases • Monotherapy • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • IL2 • PD-L1

A Phase II Study of ILKN421H With Pembrolizumab in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: iLeukon Therapeutics, Inc.

New P2 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A phase 1/IIa study of ILKN421H, a LNP mRNA encoding an IL2Rβγ selective IL-2v, as monotherapy and in combination with pembrolizumab, in patients with advanced solid tumors (SITC 2025) - P1/2 | "At the cut-off date (9.1, 2025), of the 20 efficacy evaluable 1L NSCLC patients regardless of the PDL1 expression levels, 16 were evaluated to be PR (ORR=80%), and 50% PFS was not reached.Conclusions ILKN421H was generally well tolerated at the current dose level, which already demonstrated prolonged plasma IL-2v expression, and robust stem-like CD8 T cells and NK cells proliferation in human participants. Initial signs of antitumor efficacy were seen in combination with pembrolizumab in 1L NSCLC regardless of PDL1 expression levels.Trial Registration NCT05978102"

Clinical • Combination therapy • IO biomarker • Late-breaking abstract • Metastases • Monotherapy • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • IL2 • PD-1 • PD-L1

iLeukon Therapeutics…announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application and a phase II protocol evaluating ILKN421H in combination with pembrolizumab for first line and post-IO treatment of patients with advanced NSCLC (PRNewswire)

IND • New P2 trial • Non Small Cell Lung Cancer

In a first-in-human, open-label Phase I study (NCT05978102), ILKN421H demonstrated antitumor activity and a favorable safety profile, with no cases of vascular-leak syndrome or hypotension (PRNewswire) - "In this trial evaluating ILKN421H as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, ILKN421H was well tolerated, with no dose-limiting toxicities and no maximum tolerated dose reached among the 45 enrolled patients. Combination therapy with pembrolizumab, in first-line NSCLC, achieved a confirmed objective response rate (ORR) of 80% (n=16/20) regardless of PD-L1 expression, with median progression-free survival (PFS) not yet reached and projected to exceed 12 months. The summary of this Phase I study was selected as an oral presentation at the upcoming SITC Annual Meeting, and the results will be presented on November 8, 2025."

P1 data • Non Small Cell Lung Cancer

A FIRST IN HUMAN (FIH), PHASE 1 STUDY OF CTM103, A LNP MRNA ENCODING AN IL2Rbg SELECTIVE IL-2V, AS MONOTHERAPY AND IN COMBINATION WITH PEMBROLIZUMAB, IN PATIENTS WITH ADVANCED SOLID TUMORS (SITC 2024) - P1/2 | "Conclusions CTM103 was generally well tolerated at the current dose level, which already demonstrated high and prolonged plasma level of IL-2, and robust immune stimulatory activity in promoting CD8 T cells and NK cells proliferation. Initial signs of antitumor efficacy were seen in combination with pembrolizumab, regardless of PDL-1 expression level."

Clinical • Combination therapy • IO biomarker • Late-breaking abstract • Metastases • Monotherapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • IL2 • PD-L1