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

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

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

Aulos Bioscience to Present Updated Phase 1/2 Clinical Trial Results for Novel IL-2 Therapeutic AU-007 in Advanced Solid Tumor Cancers at 2024 ASCO Annual Meeting (Businesswire) - "Aulos Bioscience...announced that updated Phase 1/2 data for AU-007 will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting. AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors in patients with unresectable locally advanced or metastatic cancers."

P1/2 data • Solid Tumor

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. | N=69 ➔ 136 | Trial completion date: Oct 2024 ➔ Jan 2025 | Trial primary completion date: Jul 2024 ➔ Oct 2024

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

First Patient Dosed in Phase 2 Portion of Aulos Bioscience’s Phase 1/2 Clinical Trial for AU-007, a Computationally Designed IL-2 Antibody for Solid Tumor Cancers (Businesswire) - "Aulos Bioscience...announced dosing of the first patient in the initial Phase 2 expansion cohorts of its Phase 1/2 clinical trial evaluating AU-007 for treatment of unresectable locally advanced or metastatic cancers....Aulos’ Phase 1/2 clinical trial is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. The initial Phase 2 expansion cohorts focus on melanoma and renal cell carcinoma (RCC), with AU-007 administered every two weeks....Preliminary Phase 2 data in melanoma, renal cell carcinoma anticipated to be presented by mid-2024."

P2 data • Trial status • Melanoma • Renal Cell Carcinoma

Aulos Bioscience Advances AU-007 to Phase 2 Portion of Phase 1/2 Study Evaluating Computationally Designed IL-2 Antibody for Treatment of Solid Tumors (Businesswire) - "Aulos Bioscience...announced plans to initiate the Phase 2 portion of its Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic solid tumor cancers of the skin and kidney. AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors....Aulos’ Phase 1/2 clinical trial is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. The trial is currently enrolling patients at multiple locations in the United States and Australia. The first Phase 2 expansion cohorts will focus on melanoma and renal cell carcinoma (RCC)."

Trial status • Melanoma • Renal Cell Carcinoma

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: interim results from dose escalation (SITC 2023) - P1/2 | "Conclusions AU-007 +/- aldesleukin reduces serum Tregs and increases NK and CD8 cells, consistent with AU-007’s mechanism of action. The mild toxicity, pharmacodynamic and early objective efficacy findings in heavily pretreated patients warrant continued escalation of AU-007 +/- aldesleukin."

Clinical • Metastases • P1/2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD8 • FCGR2A • FCGR2B • IL2 • IL2RA • IL2RG

New Phase 1 Dose Escalation Data Show Well-Tolerated Safety Profile and Anti-Tumor Activity for Aulos Bioscience’s AU-007 at Society for Immunotherapy of Cancer (SITC) Annual Meeting (Businesswire) - P1/2 | N=69 | NCT05267626 | Sponsor: Aulos Bioscience, Inc. | "The data, from Phase 1 dose escalation cohorts, continue to indicate that AU-007 is well tolerated as a monotherapy treatment or in a combination therapy regimen with low-dose, subcutaneous aldesleukin (recombinant human IL-2). The data also demonstrate early evidence of anti-tumor activity in patients with several solid tumor cancer types....We look forward to presenting clinical data from the Phase 2 expansion cohorts next year.'...All drug-related adverse events were Grade 1 or 2, with the exception of three transient Grade 3 or 4 lymphopenias that were not associated with adverse outcomes in patients receiving AU-007 and aldesleukin....The company anticipates transitioning to the Phase 2 portion of the AU-007 study by late 2023 or early 2024, with Phase 2 dose expansion cohorts planned in melanoma, RCC and NSCLC."

P1 data • P2 data • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

New Phase 1 Dose Escalation Cohorts Data for Aulos Bioscience’s AU-007 Show Favorable Pharmacodynamic Effects at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Businesswire) - P1/2 | N=69 | NCT05267626 | Sponsor: Aulos Bioscience, Inc. | "Aulos Bioscience...presented new pharmacodynamic data from the ongoing Phase 1 dose escalation portion of its Phase 1/2 clinical trial of AU-007...in a poster presentation at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics....The data demonstrate that AU-007 redirects interleukin-2 (IL-2) from regulatory T cells (Tregs) toward effector T cells (Teffs) and natural killer (NK) cells, which can kill tumor cells. The data also show a reduction in eosinophils, which at high cell counts can be associated with toxicity in the lungs.....'We also look forward to presenting new clinical efficacy and safety data from the Phase 1 dose escalation cohorts later this year'.....The trial is currently enrolling patients at multiple site locations in the United States and Australia. The company anticipates transitioning to the Phase 2 portion of the AU-007 study by year-end."

P1 data • PK/PD data • Trial status • Solid Tumor

Aulos Bioscience to Present Encouraging Pharmacodynamic Data for AU-007 From Phase 1 Dose Escalation Cohorts at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Businesswire) - P1/2 | N=69 | NCT05267626 | Sponsor: Aulos Bioscience, Inc. | "Aulos Bioscience...announced the presentation of encouraging pharmacodynamic data from the ongoing Phase 1 dose escalation portion of its Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic solid tumor cancers....In assessing the biological activity of AU-007 alone or with low dose, subcutaneous aldesleukin in patients with advanced solid tumor cancers, data show a reduction in the circulating cell counts of patients’ regulatory T cells, which suppress the immune system, as well as eosinophils, which at high cell counts can be associated with toxicity in the lungs. At the same time, the data demonstrate an overall trend in increasing natural killer cells and effector T cells that can kill tumor cells....'We look forward to presenting further details at the AACR-NCI-EORTC International Conference'."

P1 data • PK/PD data • Solid Tumor

Aulos Bioscience Announces Presentation of Updated Safety and Efficacy Data From First-in-Human Phase 1/2 Clinical Trial of AU-007 at 38th Society for Immunotherapy of Cancer (SITC) Annual Meeting (Businesswire) - "Aulos Bioscience...announced that new safety and efficacy data from the Phase 1 dose escalation portion of its Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic solid tumor cancers will be presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting....The SITC meeting is being held virtually and in San Diego, California, from November 1-5, 2023....The poster will be presented in the Poster Hall, Exhibit Halls A and B1 at the San Diego Convention Center."

P1 data • Solid Tumor