Aulos Bioscience Reports Phase 2 Imneskibart Data in Refractory Melanoma and Lung Cancer

Aulos Bioscience reported Phase 2 data on November 6, 2026 showing its lead antibody imneskibart produced a median progression-free survival of 9.1 months and a 28% objective response rate in checkpoint inhibitor-refractory melanoma. The results were presented in two posters at the Society for Immunotherapy of Cancer Annual Meeting in Phoenix, Arizona, Business Wire reported. Aulos Bioscience is a clinical-stage immuno-oncology company developing imneskibart (AU-007), an AI-designed monoclonal antibody that redirects IL-2 toward anti-tumor immune activation while avoiding regulatory T cell expansion and IL-2 toxicities.

Imneskibart's Melanoma and Lung Cancer Results

The melanoma triplet regimen of imneskibart plus low-dose subcutaneous aldesleukin and nivolumab achieved a median PFS of 9.1 months and a 28% ORR among 18 response-evaluable patients, including one confirmed complete response. The doublet regimen of imneskibart plus low-dose aldesleukin without nivolumab achieved a median PFS of 6.9 months and a 29% ORR, including a confirmed complete response lasting more than 32 months. Patients in the triplet cohort had received a mean of 2.7 prior lines of treatment and those in the doublet cohort a mean of 2.4 prior lines.

In heavily pretreated patients with advanced adenocarcinoma NSCLC, the triplet regimen of imneskibart plus low-dose subcutaneous aldesleukin and avelumab achieved a median PFS of 5.8 months, a confirmed ORR of 21% and a disease control rate of 86%. Median overall survival had not been reached at a median follow-up of 10.6 months. Patients had received a mean of 2.6 prior lines of therapy.

"We believe these are exceptional results for imneskibart in two of the most challenging populations in oncology – melanoma and NSCLC patients whose tumors have progressed despite multiple prior treatments," said Aron Knickerbocker, President and Chief Executive Officer of Aulos Bioscience.

Aulos Bioscience's Funding and Merck KGaA Agreement

According to akta.pro company records, Aulos Bioscience has raised $60 million in total, comprising a $40 million Series A from Apple Tree Partners at founding in January 2021 and a $20 million Series A extension in August 2023 led by Apple Tree Partners. In November 2024 the company entered a clinical trial collaboration and supply agreement with Merck KGaA (Ares Trading S.A.) to evaluate AU-007 in combination with avelumab and low-dose aldesleukin in a Phase 2 NSCLC cohort.

Earlier Imneskibart Presentations

In May 2026, Aulos Bioscience announced positive Phase 2 data for imneskibart in doublet checkpoint inhibitor-refractory metastatic melanoma, to be presented at ASCO 2026, showing a 33% objective response rate and 67% disease control rate in 12 evaluable patients receiving the triplet regimen of imneskibart, low-dose subcutaneous aldesleukin and nivolumab, Business Wire Blog reported. In October 2026, the company announced two presentations of Phase 1/2 data for imneskibart at the SITC 2026 Annual Meeting, FinancialContent Business Page reported. Later that month, Aulos Bioscience presented Phase 2 data for imneskibart with avelumab in checkpoint inhibitor-refractory adenocarcinoma NSCLC at ESMO 2026, the same outlet reported.

Imneskibart's Next Trial Steps

Enrollment is complete in all Phase 2 cohorts evaluating nivolumab or avelumab plus imneskibart and low-dose subcutaneous aldesleukin. Aulos Bioscience said the findings provide a foundation for advancing imneskibart into randomized clinical trials.