Drugs / imneskibart
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05267626 | Apr 2022 → Feb 2027 expected | cutaneous melanoma, metastatic malignant neoplasm, non-small cell lung carcinoma | Aulos Bioscience, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-05-21 | Aulos Bioscience, Inc. | Results Aulos Bioscience Reports Positive Phase 2 Data for Imneskibart in Doublet Checkpoint Inhibitor-Refractory Metastatic Melanoma at 2026 ASCO Annual Meeting aulosbio.com ↗
The Phase 2 data show that imneskibart-based outpatient regimens are well tolerated and demonstrate durable clinical activity, including ongoing and deepening responses. |
| 2025-11-07 | Aulos Bioscience, Inc. | Results New Phase 2 Data for Aulos Bioscience’s Imneskibart Reveal Clinical Activity in Melanoma and Non-Small Cell Lung Cancer aulosbio.com ↗
The new Phase 2 data demonstrate sustained and significant anti-tumor activity in patients with melanoma that progressed on prior doublet CPI therapy and early signals of objective responses in patients with NSCLC whose tumors progressed on prior CPI therapy, with or without chemotherapy. |
| 2025-04-29 | Aulos Bioscience, Inc. | Results Aulos Bioscience Presents New Phase 2 Data for AU-007 Demonstrating Continued Strong Anti-Tumor Activity in Advanced Cancers at AACR Annual Meeting aulosbio.com ↗
Data show clear evidence of anti-tumor activity and durable partial and complete responses in heavily pre-treated patients with tumors that progressed through checkpoint inhibitors |
| 2024-11-07 | Aulos Bioscience, Inc. | Results Strong Evidence of AU-007’s Anti-Tumor Activity in Advanced Solid Tumor Cancers Presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting aulosbio.com ↗
Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of potentially best-in-class IL-2 therapeutics, today shared positive results from its Phase 1/2 dose escalation and cohort expansion study of AU-007. |
| 2024-10-23 | Aulos Bioscience, Inc. | Results Aulos Bioscience Presents Phase 2 Dose Selection Data for Novel IL-2 Therapeutic Antibody, AU-007, at 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics aulosbio.com ↗
Safety data presented at the EORTC-NCI-AACR Symposium demonstrate manageable toxicity for AU-007 and low-dose, subcutaneous aldesleukin, with no vascular leak syndrome or pulmonary edema at all dose levels evaluated. |
| 2024-05-23 | Aulos Bioscience, Inc. | Results Aulos Bioscience Provides Positive Interim Phase 1/2 Data From AU-007 at 2024 ASCO Annual Meeting aulosbio.com ↗
A patient with bladder cancer whose tumors had progressed through an anti-PD-L1 checkpoint inhibitor was treated with AU-007 (4.5 mg/kg) and one 45K IU/kg IL-2 dose and achieved a durable metabolic complete response. |
All press releases naming this drug 14 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | imneskibart | “This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007, also known as imneskibart, in...” NCT05267626 ↗ |
| Known as | AU-007 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05267626 ↗ |
| Action | Inhibit | “AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding” NCT05267626 ↗ |
| Modality | Monoclonal antibody | “AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding” NCT05267626 ↗ |
| Target | IL2 | “AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding” NCT05267626 ↗ |