Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of its lead immune-activating antibody therapeutic imneskibart (AU-007), today presented positive Phase 2 data for imneskibart with avelumab in checkpoint inhibitor (CPI)-refractory adenocarcinoma non-small cell lung cancer (NSCLC). The data were shared in a poster session at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

The Phase 2 results demonstrate promising clinical activity with imneskibart plus low-dose, subcutaneous aldesleukin and avelumab in heavily pre-treated patients with CPI-refractory advanced adenocarcinoma NSCLC. Median progression-free survival (PFS) was 5.8 months, confirmed objective response rate (ORR) was 21% and disease control rate was 86% among 14 response-evaluable patients. Patients in this study were on average heavily pre-treated and had received a mean of 2.6 prior lines of therapy. For context, historical studies in less pre-treated patients reported with the standard-of-care treatment, docetaxel, demonstrated ORRs of approximately 4% to 15% and median PFS of 2.8 to 3.9 months in adenocarcinoma populations following only one prior line of therapy.

“These clinical results show remarkable progression-free survival in patients whose lung cancers have progressed despite multiple lines of prior therapies, including checkpoint inhibition, and who have very limited treatment options,” said Aron Knickerbocker, President and Chief Executive Officer of Aulos Bioscience. “A median PFS of 5.8 months, durable and confirmed responses, and prolonged disease control in such heavily pre-treated patients exceed what would be expected with standard-of-care docetaxel therapy, and provide a strong rationale for advancing this immunotherapy triplet into randomized clinical trial evaluation in lung cancer. The accompanying safety profile and immune changes also reinforce our confidence in imneskibart’s differentiated mechanism and its potential to address an important unmet medical need.”

As of the September 18, 2026 data cutoff, data were available from 26 patients (with adenocarcinoma or squamous histology) in the Phase 2 avelumab combination cohort, 16 of adenocarcinoma histology, of whom 14 were evaluable for response:

Clear, sustained activity observed with imneskibart triplet in CPI-refractory adenocarcinoma NSCLC

  • Median PFS of 5.8 months.

  • 21% ORR in confirmed CPI-refractory adenocarcinoma NSCLC patients following prior anti-PD-1/-L1 treatment with or without chemotherapy.

  • Three of 14 patients achieved confirmed and durable objective responses, with target tumor reductions of 42%, 43% and 45%.

  • Nine of 14 patients achieved stable disease, including five with tumor reductions of -27%, -20%, -9%, -6% and -1%, resulting in an 86% disease control rate.

  • Mean number of lines of prior therapy: 2.6.

  • Median overall survival (OS) data were not reached at 10.6 months of median follow-up, and continued assessments will characterize survival outcomes.

Imneskibart and low-dose, subcutaneous aldesleukin with avelumab continues to exhibit unique pharmacodynamic (PD), biological and pharmacokinetic (PK) effects, with a higher peripheral blood CD8/Treg ratio correlating with longer PFS

  • CD8/Treg ratios increased from baseline substantially, supporting the biological rationale for redirecting interleukin-2 (IL-2) toward effector T cells.

  • PD data continue to build on prior findings of durable increases in CD8 T cells and CD8/Treg ratios, with a corresponding decrease in regulatory T cells (Tregs), further validating imneskibart’s unique mechanism of action of redirecting IL-2 away from trimeric IL-2 receptors (expressed on Tregs and blood vessels) and toward dimeric IL-2 receptors (on CD8+ T effector and natural killer cells).

  • The data show that this durable activity, coupled with a persistent reduction in Tregs and a higher CD8/Treg ratio, is associated with longer OS, PFS and time on treatment for patients, as previously presented in data disclosures.

  • PK data continue to demonstrate sustained, selective signaling with a half-life of greater than 19.5 days, enabling potent immune activation without Treg expansion or high-dose IL-2 toxicities such as vascular leak syndrome or pulmonary edema.

  • Avelumab is an anti-PD-L1 antibody with an active Fc domain and antibody-dependent cellular cytotoxicity (ADCC) effector function mediated by natural killer (NK) cells; on average, imneskibart increased NK cell counts nearly three-fold from baseline.

Well-tolerated triplet regimen, with manageable safety profile and low rate of Grade 3/4 adverse events following addition of avelumab

  • Most drug-related adverse events were Grade 1 or 2, with imneskibart and a subcutaneous loading dose of aldesleukin alone or in combination with avelumab.

  • No capillary leak syndrome or treatment-related deaths were observed.

  • The emerging safety profile of the triplet regimen is consistent with the known safety profiles of avelumab and imneskibart plus aldesleukin, with no new toxicity signals observed.

Enrollment is complete in the Phase 2 triplet cohort evaluating avelumab plus imneskibart and low-dose, subcutaneous aldesleukin.

The poster, “Imneskibart (AU-007) + low-dose SC IL-2 + avelumab: Phase 2 activity in CPI-refractory advanced adenocarcinoma NSCLC” (Abstract 6280) is accessible to meeting registrants as an electronic poster on the ESMO Congress 2026 virtual platform. It is also available on the Aulos Bioscience website in the Abstracts and Publications section.

To learn more about the imneskibart clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About Imneskibart

Imneskibart (AU-007) is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, imneskibart redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. Imneskibart also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

About Aulos

Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through immune-activating antibody therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, imneskibart (AU-007), is a human antibody designed by leveraging artificial intelligence that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners (ATP) and is led by pioneers in the fields of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulos.com, X (@AulosBioscience) and LinkedIn.

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