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<\/a><\/a>\nThe Phase 2 data show that imneskibart-based outpatient regimens are well tolerated and demonstrate durable clinical activity, including ongoing and deepening responses. Patients received either imneskibart plus low-dose, subcutaneous aldesleukin or the triplet regimen of imneskibart plus low-dose, subcutaneous aldesleukin and nivolumab. Across the study, imneskibart treatment was associated with sustained regulatory T cell (Treg) reduction, increased CD8\/Treg ratios and evidence of durable anti-tumor activity, supporting its differentiated IL-2 mechanism.<\/p>
\n\u201cImneskibart\u2019s triplet regimen produced a 33% objective response rate and 67% disease control rate in metastatic melanoma patients whose disease progressed following earlier treatment with potent checkpoint inhibitor doublets,\u201d said Aron Knickerbocker, Aulos Bioscience\u2019s President and Chief Executive Officer<\/a>. \u201cThese patients urgently need safe, life-extending treatment options, particularly those who are not eligible for or do not receive TIL therapy. While lifileucel TIL therapy is the only FDA-approved product specifically indicated in the post-PD-1 setting, a substantial treatment gap remains. In addition to durable efficacy consistent with anti-tumor immune memory formation, imneskibart continues to demonstrate a differentiated, potentially best-in-class safety profile. These findings strongly support imneskibart\u2019s mechanism and its ability to make a meaningful difference for patients.\u201d<\/p> \nAs 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:<\/p> \nClinically meaningful activity observed with imneskibart triplet in doublet CPI-refractory melanoma<\/b><\/p> \nStrong 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)<\/b><\/p> \nImneskibart and low-dose, subcutaneous aldesleukin, with or without nivolumab, exhibits unique pharmacodynamic (PD), biological and pharmacokinetic (PK) effects in the IL-2 class, with a higher peripheral blood CD8\/Treg ratio correlating with increased survival<\/b><\/p> \nWell-tolerated triplet regimen, with no apparent increase in Grade 3\/4 adverse events following addition of nivolumab<\/b><\/p> \nEnrollment is complete in the Phase 2 doublet cohort evaluating imneskibart plus a single loading dose of low-dose, subcutaneous aldesleukin in patients with unresectable locally advanced or metastatic cutaneous melanoma following confirmed progression on doublet CPI therapy. Enrollment continues in the Phase 2 triplet cohort evaluating imneskibart plus low-dose, subcutaneous aldesleukin and nivolumab in approximately 20 evaluable second-line cutaneous melanoma patients, with plans advancing toward potential registrational development.<\/p> \nTwo ongoing Phase 2 cohorts are evaluating imneskibart and low-dose, subcutaneous aldesleukin administered without and with avelumab (anti-PD-L1 with an active Fc domain and ADCC effector function) in patients with advanced PD-L1+ non-small cell lung cancer (NSCLC) that progressed on prior CPI therapy (with or without chemotherapy). Aulos anticipates presenting comprehensive clinical data from the NSCLC Phase 2 cohorts by year-end.<\/p> \nThe poster, \u201cImneskibart + low-dose subcutaneous IL-2 \u00b1 nivolumab in patients with CPI-refractory cutaneous melanoma: Promising results from an ongoing phase 1\/2 study,\u201d (Abstract 9526) will be presented live in the poster session \u201cMelanoma\/Skin Cancers\u201d in the Exhibit Hall at McCormick Place on Sunday, May 31, 2026, 9:00 a.m. to 12:00 p.m. CDT. The poster will also be accessible to meeting registrants as an electronic poster on the ASCO online meeting platform.<\/p> \nTo learn more about the imneskibart clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626<\/a>). For patients and providers in the U.S., please visit www.solidtumorstudy.com<\/a>. For patients and health professionals in Australia, please visit www.solidtumourstudy.com<\/a>.<\/p> \nAbout Imneskibart<\/b><\/p> \nImneskibart (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.<\/p> \nAbout Aulos<\/b><\/p> \nAulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through immune-activating antibody therapeutics that direct patients\u2019 immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design<\/a> with an in-depth understanding of the immune system, Aulos\u2019 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<\/a>) and is led by pioneers in the fields of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulos.com<\/a>, X (@AulosBioscience<\/a>) and LinkedIn<\/a>.<\/p> \ninfo@aulosbio.com<\/a> 33% ORR and 67% disease control observed with imneskibart triplet in metastatic melanoma following confirmed progression on potent doublet checkpoint inhibitor therapy\n
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\nDurable responses, Treg reduction and increased CD8\/Treg ratio support imneskibart\u2019…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-9943","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/9943","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=9943"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/9943\/revisions"}],"predecessor-version":[{"id":9944,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/9943\/revisions\/9944"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=9943"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=9943"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=9943"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}