imneskibart (AU-007) / Aulos Biosci - LARVOL DELTA

Imneskibart (AU-007) + low-dose SC IL-2 + avelumab: Phase 2 activity in CPI-refractory advanced adenocarcinoma NSCLC (ESMO 2026) - No abstract available

Metastases • P2 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IL2

Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2R? Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=159 | Recruiting | Sponsor: Aulos Bioscience, Inc. | Trial completion date: Jun 2026 ➔ Feb 2027 | Trial primary completion date: Jun 2026 ➔ Feb 2027

First-in-human • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • BRAF

Imneskibart + low-dose subcutaneous IL-2 ± nivolumab in patients with CPI-refractory cutaneous melanoma: Promising results from an ongoing phase 1/2 study. (ASCO 2026) - P1/2 | "Funded by Aulos Bioscience Clinical Trial Registration Number: NCT05267626 Background: Imneskibart (AU-007) is an AI designed monoclonal antibody binding to interleukin-2 (IL-2) preventing binding to CD25 in the trimeric IL-2 receptor (IL-2 R), while allowing engagement with the dimeric IL-2R, CD122/CD132...Both cohorts receive subcutaneous (SC) 135K IU/kg aldesleukin dose on Day 1 of first cycle with additional doses of aldesleukin administered at the beginning of each cycle until at least a partial response (PR) is obtained... Compelling anti-tumor activity is observed with imneskibart + IL-2, with a strong emerging signal of enhanced activity with the nivolumab combination in pts with melanoma refractory to doublet CPI therapy. Imneskibart + IL-2–associated Treg reduction likely drives the high disease control rate, supporting durable benefit with prolonged treatment exposure and PFS."

Clinical • P1/2 data • Cutaneous Melanoma • Melanoma • Solid Tumor • CD8 • FCGR2A • FCGR2B • IL2 • IL2RA • IL2RG

Aulos Bioscience Reports Positive Phase 2 Data for Imneskibart in Doublet Checkpoint Inhibitor-Refractory Metastatic Melanoma at 2026 ASCO Annual Meeting (Businesswire) - "As of the April 6, 2026 data cutoff, data were available from 83 patients across the Phase 1/2 study, including 12 patients in the Phase 2 melanoma triplet cohort evaluable for response....33% objective response rate (ORR) in confirmed doublet CPI-refractory cutaneous melanoma patients following prior anti-PD-1/CTLA-4 or anti-PD-1/LAG-3 therapy. Four of 12 patients achieved partial responses, with target tumor reductions of 52%, 65%, 74% and 77%. Four of 12 patients achieved stable disease, resulting in a 67% disease control rate....Strong signal of anti-tumor activity in imneskibart doublet regimen, with ongoing deep and durable tumor reductions in patients who progressed after receiving doublet CPI therapy (prior anti-PD-1 and anti-CTLA-4 and/or anti-PD-1 and anti-LAG-3)....Aulos anticipates presenting comprehensive clinical data from the NSCLC Phase 2 cohorts by year-end."

P2 data • Cutaneous Melanoma • Non Small Cell Lung Cancer

Aulos Bioscience Announces Presentation of Promising Phase 1/2 Data for Imneskibart in Melanoma at 2026 ASCO Annual Meeting (Businesswire) - "The presentation will focus on promising results for imneskibart with and without nivolumab in checkpoint inhibitor (CPI)-refractory cutaneous melanoma."

P1/2 data • Cutaneous Melanoma

AU-007, a human monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, plus low-dose aldesleukin, in advanced solid tumors: Phase 2 update (AACR 2025) - "The ongoing Phase 2 (Ph2) cohort expansion evaluates the recommended Ph2 dose (RP2D) in patients with melanoma (mel), renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC) ± avelumab (data not reported) having protocol defined measurable disease at baseline. As of 02 December 2024, 86 patients enrolled into the study...A mel patient refractory to anti-PD-1 + relatlimab therapy had a 55% reduction (ongoing at 7 M)... AU-007 + low-dose SC aldesleukin exhibits a manageable toxicity profile with promising efficacy and durability of activity across multiple tumor types. Ph 2 cohorts evaluating melanoma, RCC, and NSCLC are ongoing."

Metastases • P2 data • Bladder Cancer • Colon Cancer • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • FCGR2A • FCGR2B • IL2 • IL2RA • IL2RG

New Phase 2 Data for Aulos Bioscience’s Imneskibart Reveal Clinical Activity in Melanoma and Non-Small Cell Lung Cancer (Businesswire) - "Phase 2 data presented at the 40th Society for Immunotherapy of Cancer (SITC) Annual Meeting show deep and durable tumor regressions in heavily pre-treated melanoma patients, with a mild safety profile easily managed in outpatient setting; early signals of objective responses observed in patients with non-small cell lung cancer. Additional durable, complete responses observed in two patients with bladder cancer and head and neck cancer for more than two years, following treatment with imneskibart and low-dose aldesleukin."

P2 data • Bladder Cancer • Head and Neck Cancer • Melanoma • Non Small Cell Lung Cancer

Imneskibart, a human monoclonal antibody (mAb) that binds IL-2 and prevents CD25 binding, + low-dose subcutaneous IL-2: Phase 2 update on CPI-refractory melanoma and non-small cell lung cancer (NSCLC) (SITC 2025) - "Background Imneskibart (AU-007) is a mAb binding to interleukin-2 (IL-2) at an epitope that prevents binding to CD25 in the trimeric IL-2 receptor, while allowing engagement with the dimeric receptor, CD122/CD132...Ph2 Cohort 1 evaluates the RP2D and Cohort 4 evaluates the RP2D-1/RP2D + nivolumab (data immature, not reported), both in melanoma; Cohort 2 evaluates the RP2D and Cohort 3 evaluates the RP2D-1/RP2D + avelumab in PD-L1-positive (≥1%) NSCLC that progressed on anti-PD-1/L1 ± chemotherapy.Results Twelve melanoma patients enrolled in Cohort 1 and two in Ph1 (received below the RP2D)...Updated data, including additional patients, will be presented at the conference.Acknowledgements Avelumab was provided by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945).Trial Registration NCT05267626Ethics Approval This study was approved by Monash Health (Australia) HREC/80672/MonH-2021-295282(v2) and Advarra IRB (US)..."

P2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FCGR2A • FCGR2B • IL2 • IL2RA • IL2RG

Aulos Bioscience to Present Updated Phase 2 Data for Imneskibart (AU-007) in Melanoma and Non-Small Cell Lung Cancer at 40th Society for Immunotherapy of Cancer (SITC) Annual Meeting (Businesswire)

P2 data • Melanoma • Non Small Cell Lung Cancer

Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=159 | Recruiting | Sponsor: Aulos Bioscience, Inc. | Trial completion date: Sep 2025 ➔ Jun 2026 | Trial primary completion date: Aug 2025 ➔ Jun 2026

First-in-human • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor

Aulos Bioscience Presents New Phase 2 Data for AU-007 Demonstrating Continued Strong Anti-Tumor Activity in Advanced Cancers at AACR Annual Meeting (Businesswire) - P1/2 | N=159 | NCT05267626 | Sponsor: Aulos Bioscience, Inc. | "The interim Phase 2 data demonstrate clear evidence of durable partial and complete tumor response in multiple cancer types, including patients with melanoma whose tumors had progressed through prior checkpoint inhibitors and who received a combination of AU-007 and low-dose...Durable tumor shrinkages were also observed in patients with checkpoint inhibitor-resistant or progressed renal cell carcinoma (RCC) who received the same AU-007 and aldesleukin regimen. Additionally, AU-007 and low-dose, subcutaneous aldesleukin continues to demonstrate a unique pharmacodynamic (PD) profile in the interleukin-2 (IL-2) class, with regulatory T cells (Tregs) decreasing and CD8 effector T cells expanding at all AU-007 dose levels...Durable objective responses were observed....Aulos anticipates presenting preliminary clinical data from these two Phase 2 expansion cohorts in the second half of 2025."

P2 data • PK/PD data • Melanoma • Renal Cell Carcinoma

Aulos Bioscience Doses First Patient in Phase 2 Cohort Evaluating AU-007 in Combination With Nivolumab for Second-Line Treatment of Melanoma (Businesswire) - "Aulos Bioscience...announced dosing of its first patient with a combination of AU-007, the anti-PD-1 antibody nivolumab and low-dose, subcutaneous aldesleukin in a Phase 2 expansion cohort focused on second-line treatment of melanoma. This new cohort is part of Aulos’ Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic cancer."

Trial status • Melanoma

Aulos Bioscience to Present Promising Phase 2 Data for Novel IL-2 Therapeutic AU-007 in Melanoma at AACR Annual Meeting (Businesswire) - "Aulos Bioscience...announced the presentation of new data from the Phase 2 portion of its Phase 1/2 clinical trial of AU-007 at the American Association for Cancer Research (AACR) Annual Meeting. The presentation will focus on promising results for AU-007 in second-line treatment of melanoma."

P2 data • Melanoma

Aulos Bioscience Doses First Patient in Phase 2 Cohort Evaluating the Combination of Avelumab and AU-007 for the Treatment of Non-Small Cell Lung Cancer (Businesswire) - "Aulos Bioscience...announced dosing of the first patient with AU-007, avelumab, a PD-L1 antibody with Fc effector function, and low-dose, subcutaneous aldesleukin in a Phase 2 cohort focused on the second-line treatment of PD-L1+ non-small cell lung cancer (NSCLC). The Phase 2 cohort is a clinical trial collaboration with Ares Trading S.A., a Swiss subsidiary of Merck KGaA, Darmstadt, Germany, and part of Aulos’ Phase 1/2 clinical trial of AU-007....The AU-007 Phase 1/2 study is currently enrolling patients with unresectable locally advanced or metastatic cancer at multiple clinical trial site locations in the United States and Australia....Aulos plans to share preliminary data from the Phase 2 cohort studying AU-007 with avelumab and low-dose, subcutaneous aldesleukin as a second-line treatment for PD-L1+ NSCLC in the first half of 2025."

P2 data • Trial status • Non Small Cell Lung Cancer

A phase 1/2 dose escalation and cohort expansion study of AU-007, a human monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, plus low-dose aldesleukin in advanced solid tumors (SITC 2024) - P1/2 | "Phase 2 cohorts evaluating AU-007 + aldesleukin in melanoma, RCC, and NSCLC are ongoing, and the combination of AU-007 + aldesleukin with the anti-PD-L1 antibody avelumab will be evaluated in NSCLC. Sixty-four patients enrolled as of 03 June 2024: 55 in dose escalation and 9 in cohort expansion. *Includes backfill patients enrolled in cohort once dose limiting toxicity observation period was cleared"

Metastases • P1/2 data • Bladder Cancer • Colorectal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • FCGR2A • FCGR2B • IL2 • IL2RA • IL2RG

SITC: Aulos Bioscience Presents Strong Evidence of AU-007’s Anti-Tumor Activity (Businesswire) - P1/2 | N=159 | NCT05267626 | Sponsor: Aulos Bioscience, Inc. | "Key findings from preliminary results of the Phase 1/2...study of AU-007, with data available on 77 patients as of the data cutoff date of September 28, 2024, are as follows:...Two patients with melanoma refractory to prior anti-CTLA-4 and anti-PD-1 therapy were treated with AU-007 every two weeks (Q2W) and one administration of low-dose, subcutaneous aldesleukin (recombinant human IL-2), and experienced deep and durable tumor shrinkages of 48% and 100% in target lesions. One patient in dose escalation with acral melanoma that progressed rapidly on prior anti-PD-1 therapy received AU-007 Q2W and one loading dose of subcutaneous aldesleukin....Anti-tumor activity was also observed in heavily pre-treated patients with RCC, bladder cancer, HNSCC and NSCLC whose tumors had progressed through checkpoint inhibitors....The company anticipates presenting updated clinical data in the first half of 2025."

P1/2 data • Bladder Cancer • Melanoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Strong Evidence of AU-007’s Anti-Tumor Activity in Advanced Solid Tumor Cancers Presented at Society for Immunotherapy of Cancer (SITC) Annual Meeting (Businesswire) - P1/2 | N=159 | NCT05267626 | Sponsor; Aulos Bioscience, Inc. | "Preliminary Phase 2 data reveal that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in melanoma, a finding consistent with Phase 1 data demonstrating clinical activity in a range of patients whose tumors had progressed through prior checkpoint inhibitors. Data from all 77 patients show durable reductions in immunosuppressive Treg cells – a result unprecedented in the IL-2 class – with a correlation between longer progression-free survival outcomes as Treg reduction deepens....No dose-limiting toxicity occurred throughout Phase 1 dose escalation....Anti-tumor activity was also observed in heavily pre-treated patients with renal cell carcinoma (RCC), bladder cancer, head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) whose tumors had progressed through checkpoint inhibitors."

P1/2 data • Bladder Cancer • Lung Cancer • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Determination of the phase 2 dose of AU-007, an AI-designed human monoclonal antibody that redirects IL-2 to T-effector cells (EORTC-NCI-AACR 2024) - P1/2 | "Based on the totality of the data, a phase 2 dose of 9 mg/kg AU-007 given Q2W with 135,000 IU/kg of aldesleukin (either as a single loading dose or Q2W) was chosen for evaluation in Phase 2."

P2 data • Oncology • CD8 • IFNG • IL2 • IL2RA

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 (Businesswire) - P1/2 | N=159 | NCT05267626 | Sponsor: Aulos Bioscience, Inc. | "Aulos Bioscience...shared data and analyses used to determine dose selection for Phase 2 expansion cohorts in a Phase 1/2 clinical trial of its lead candidate, AU-007....The results continue to affirm AU-007’s unique profile among interleukin-2 (IL-2) therapeutics, showing regulatory T cell (Treg) reduction, and demonstrating that deeper drops in peripheral Treg counts were associated with longer progression-free survival (PFS) outcomes in patients from the Phase 1 and Phase 2 portions of the AU-007 trial, across a range of dose levels, tumor types and lines of therapy....Additionally, the AU-007 pharmacokinetic data show characteristics typical of an IgG1-LALA monoclonal antibody, with no evidence of neutralizing anti-drug antibody (ADA) activity and an approximate half-life of more than 15 days."

P2 data • Oncology • Solid Tumor

Aulos Bioscience Announces Presentation Detailing Phase 2 Dose Selection for AU-007 in Solid Tumor Treatment at 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (Businesswire) - "Aulos Bioscience...announced that pharmacokinetic data for evaluation of AU-007 in the Phase 2 portion of its Phase 1/2 clinical trial will be presented at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.....'With the Phase 1 trial of AU-007 completing the dose escalation and expansion phase, we are pleased to share the pharmacokinetic data used to determine dose selection of AU-007 for the Phase 2 portion of the trial'..."

P1/2 data • PK/PD data • Solid Tumor

Aulos Bioscience to Present Promising Phase 2 Data for Novel IL-2 Therapeutic Antibody, AU-007, at 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting (Businesswire) - "Aulos Bioscience...today announced the presentation of continued promising safety and efficacy data from Phase 2 dose expansion cohorts in the Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic solid tumor cancers. The new data will be presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting, being held virtually and in Houston, Texas, from November 6-10, 2024....The Phase 2 dose expansion data for our monoclonal antibody, AU-007, continue to build upon the positive clinical data presented at ASCO and we look forward to presenting further details, particularly early Phase 2 data in melanoma and renal cell carcinoma, at the SITC Annual Meeting."

P2 data • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma

Updated results of a phase 1/2 study of AU-007, a monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, in patients with advanced solid tumors. (ASCO 2024) - P1/2 | "The mild toxicity profile and promising early efficacy observed in dose escalation across multiple tumor types in heavily pretreated patients, along with initial pharmacodynamic data, warrant continued evaluation of AU-007 + low dose SC aldesleukin in the Phase 2 expansion cohorts of the study."

Clinical • Metastases • P1/2 data • Anemia • Colorectal Cancer • Fatigue • Hematological Disorders • Kidney Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • FCGR2A • FCGR2B • IL2 • IL2RA • IL2RG

Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer (clinicaltrials.gov) - P1/2 | N=136 | Recruiting | Sponsor: Aulos Bioscience, Inc. | Trial completion date: Jan 2025 ➔ Sep 2025 | Trial primary completion date: Oct 2024 ➔ Aug 2025

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Aulos Bioscience Provides Positive Interim Phase 1/2 Data From AU-007 at 2024 ASCO Annual Meeting (Businesswire) - P1/2 | N=136 | NCT05267626 | Sponsor: Aulos Bioscience, Inc. | "Aulos Bioscience...shared interim results from its Phase 1/2 trial of AU-007...The data will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, Illinois...No evidence of vascular leak syndrome or pulmonary edema reported at all dose levels evaluated...Another patient with metastatic melanoma whose tumors had also progressed through anti-PD-1 and anti-CTLA-4 checkpoint inhibitors was treated with AU-007 (4.5 mg/kg) and one 15K IU/kg low dose of IL-2 and achieved 48% shrinkage in target lesions....Decreases in peripheral regulatory T cells (Tregs) and increases in CD8/Treg ratios demonstrate AU-007’s ability to redirect IL-2 and prevent the negative feedback loop to Tregs....The Phase 2 expansion cohorts of the AU-007 study are continuing to enroll patients with a focus on melanoma and RCC."

P1/2 data • Trial status • Bladder Cancer • Colorectal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Aulos Bioscience Enters Into Clinical Trial Collaboration and Supply Agreement With Merck KGaA, Darmstadt, Germany To Study Combination of Bavencio With AU-007 (Businesswire) - "Aulos Bioscience...announced a new collaboration and supply agreement with Ares Trading S.A., a Swiss subsidiary of Merck KGaA, Darmstadt, Germany, for use of Bavencio (avelumab) in a clinical study of its lead human monoclonal antibody candidate, AU-007. Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will provide Aulos with a free supply of Bavencio to evaluate in combination with AU-007 and low-dose, subcutaneous aldesleukin in an additional Phase 2 cohort of Aulos’ Phase 1/2 clinical trial of AU-007 in solid tumor cancers....Aulos plans to present additional Phase 1 data and preliminary Phase 2 data, with a focus on melanoma and renal cell carcinoma, at an upcoming medical conference. The company anticipates commencing patient enrollment in the Phase 2 cohort studying Bavencio with AU-007 and aldesleukin in the second half of 2024."

Licensing / partnership • P1/2 data • Trial status • Kidney Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor