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DRUG CLASS:

IL-2R agonist

1m
Neo-DREAM: Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients (clinicaltrials.gov)
P3, N=186, Recruiting, Philogen S.p.A. | Trial completion date: Jun 2026 --> Dec 2031 | Trial primary completion date: Jun 2024 --> Dec 2027
Trial completion date • Trial primary completion date
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Nidlegy (darleukin/fibromun)
2ms
A Study to Evaluate Safety and Anti-Tumor Activity of Eciskafusp Alfa (RO7284755) Alone or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=189, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | Trial completion date: Aug 2026 --> Oct 2025 | Trial primary completion date: Jan 2026 --> Oct 2025
Trial completion • Trial completion date • Trial primary completion date • Tumor mutational burden • IO biomarker
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PD-L1 (Programmed death ligand 1)
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Tecentriq (atezolizumab) • eciskafusp alfa (RG6279)
2ms
New P2 trial
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Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
2ms
L19IL2/TNF in Patients With Basal Cell Carcinoma (clinicaltrials.gov)
P2, N=92, Not yet recruiting, Philogen S.p.A.
New P2 trial
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Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
2ms
New P2 trial
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Nidlegy (darleukin/fibromun) • darleukin (L19IL2)
4ms
PD-1-Cis IL-2R Agonism Determines the Predicted Pharmacological Dose Range for the Immunocytokine Eciskafusp Alfa (PD1-IL2v). (PubMed, CPT Pharmacometrics Syst Pharmacol)
Furthermore, binding in cis-configuration is expected to follow a "bell-shaped" relationship with drug concentration such that high concentrations may lead to reduced benefit/risk ratio compared with concentrations around the peak of the bell-shape. Model simulations identify patient cohorts for whom the upper limit of the pharmacological dosing range may be defined by either undesirable off-tumor target engagement or a decrease in on-tumor cis-binding.
Journal
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CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IL2RA (Interleukin 2 receptor, alpha)
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eciskafusp alfa (RG6279)
5ms
Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (clinicaltrials.gov)
P3, N=456, Terminated, Mural Oncology, Inc | Trial completion date: May 2027 --> May 2025 | Active, not recruiting --> Terminated | Trial primary completion date: May 2026 --> Jan 2025; Study terminated due to business and strategic decision.
Trial completion date • Trial termination • Trial primary completion date • Platinum resistant
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Keytruda (pembrolizumab) • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • nemvaleukin alfa (ALKS 4230)
5ms
Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus (clinicaltrials.gov)
P2, N=66, Not yet recruiting, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
New P2 trial
6ms
Nemvaleukin alfa monotherapy in patients with advanced melanoma and renal cell carcinoma: results from the phase 1/2 non-randomized ARTISTRY-1 trial. (PubMed, J Immunother Cancer)
Nemvaleukin demonstrated pharmacodynamic proof of mechanism, with single-agent antitumor activity and manageable safety in patients with advanced melanoma and RCC.
P1/2 data • Journal
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CD8 (cluster of differentiation 8)
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Keytruda (pembrolizumab) • nemvaleukin alfa (ALKS 4230)
6ms
Trial primary completion date
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Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)
6ms
ANV600 is a novel PD-1 targeted IL-2Rβγ agonist that selectively expands tumor antigen-specific T cells and potentiates PD-1 checkpoint inhibitor therapy. (PubMed, J Immunother Cancer)
ANV600 represents a novel approach to delivering IL-2Rβγ agonism specifically to PD-1+ cells while preserving the binding site for PD-1 checkpoint inhibitors. By targeting a non-blocking epitope on PD-1, ANV600 enables the selective expansion of tumor-reactive CD8+ T cells while allowing independent and optimized dosing of both agents. This design ensures combinability with PD-1 inhibitors at clinically relevant doses, including in patients previously treated with checkpoint blockade. These findings support the clinical development of ANV600 as both a monotherapy and a combination therapy in cancer immunotherapy.
Journal • Checkpoint inhibition
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CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
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BRAF V600
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • fingolimod
7ms
BelieveIT-201: TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=27, Terminated, Ascendis Pharma A/S | Completed --> Terminated; The Sponsor made the decision to close enrollment as part of a strategic portfolio review.
Trial termination
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Keytruda (pembrolizumab) • onvapegleukin alfa (TransCon IL-2 β/γ) • resiquimod SR (TransCon TLR7/8 Agonist)