BASEL, Switzerland — May 28, 2026
Anaveon announced new clinical data from its Phase 1 EXPAND-1 trial showing encouraging anti-tumor activity for ANV600 (sunekafusp alpha), a novel PD-1-targeted IL-2R-βγ agonist, in patients with advanced solid tumors. The data will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting as the company simultaneously explores global partnering opportunities for its oncology portfolio following its strategic shift toward immunology and inflammatory diseases.
ANV600 Demonstrates Encouraging Clinical Responses in Advanced Solid Tumors
ANV600 is designed to selectively activate tumor-reactive PD-1+ CD8+ T cells while reducing the severe toxicities historically associated with traditional IL-2 therapies. The therapy is also engineered to work alongside existing checkpoint inhibitors and may offer potential benefits for patients whose cancers have become resistant to immunotherapy treatments.
According to data from the ongoing EXPAND-1 Phase 1 study, ANV600 demonstrated meaningful clinical benefit both as a monotherapy and in combination with pembrolizumab. Researchers reported a complete response (CR) in a patient with non-small cell lung cancer (NSCLC) who had previously progressed on checkpoint inhibitor therapy and was treated with ANV600 alone at 120 µg/kg every two weeks. Additional partial responses (PRs) were observed in two patients receiving ANV600 combined with pembrolizumab.
The trial also showed encouraging tumor shrinkage activity. Target lesion reductions were observed in 29% of patients treated with ANV600 monotherapy and 24% of patients receiving the combination regimen. Disease control rates — including complete response, partial response, or stable disease — reached 42% in the monotherapy arm and 59% in combination-treated patients.
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Favorable Safety Profile Supports Further Development Potential
Investigators noted that ANV600 demonstrated a favorable safety and tolerability profile during the Phase 1 study. The therapy was generally well tolerated both alone and in combination with pembrolizumab, supporting continued development in advanced cancers with limited treatment options.
The study also established a recommended Phase 2 dosing regimen of 90 µg/kg weekly for four weeks followed by 150 µg/kg every two weeks. Pharmacodynamic analyses further showed that ANV600 treatment increased CD8+ T cells and natural killer (NK) cells relative to regulatory T cells, reinforcing the therapy’s intended immune activation mechanism.
Professor Markus Jörger of Health Ostschweiz in Switzerland stated that patients with advanced solid tumors derived meaningful clinical benefit from ANV600, particularly those who had exhausted currently available therapies. He added that the study demonstrated a compelling balance of safety, efficacy, and proof-of-mechanism data in heavily pretreated patients.
Anaveon Pursues Strategic Partnerships for Oncology Portfolio
Following its transition toward autoimmune and inflammatory disease development, Anaveon is now actively seeking strategic partners to continue advancing its oncology pipeline. The company indicated it is open to licensing agreements, co-development collaborations, or portfolio acquisition opportunities for its immuno-oncology assets.
Beyond ANV600, Anaveon’s oncology portfolio includes ANV700, a preclinical PD-1-targeted IL-21 fusion protein, as well as ANV419, an earlier-generation IL-2 fusion therapy with prior clinical safety data. The company believes its proprietary cis-signaling cytokine delivery platform offers differentiated potential for next-generation immuno-oncology therapies.
The ANV600 data will be presented during the Developmental Therapeutics – Immunotherapy session at ASCO 2026 in Chicago on May 30.
Source: Anaveon press release
