On May 28, 2026 Anaveon, a late-stage preclinical biotechnology company focused on reprogramming the immune system for the treatment of autoimmune and inflammatory diseases, reported that new clinical data from its legacy oncology asset ANV600 (sunekafusp alpha) will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
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Following its strategic pivot to immunology, Anaveon is actively seeking global development and commercialization partners for its oncology portfolio to maximize the potential of these highly differentiated assets.
ANV600 is a first-in-class, non-blocking PD-1-targeted IL-2R-βγ agonist designed to selectively expand tumor-reactive PD-1+ CD8+ effector T cells while reducing the toxicities historically associated with IL-2 therapy. It is compatible with existing Check Point Inhibitors (CPI) and is positioned for use in CPI-resistant and CPI-relapsed patients.
Key results from the EXPAND-1 Phase 1 study will be highlighted in the poster:
The encouraging preliminary antitumor activity observed with ANV600 should be investigated further through additional clinical studies with larger patient populations,
ANV600 is well tolerated as a monotherapy and in combination with pembrolizumab,
A complete response (CR) was observed in a patient with NSCLC (non-small cell lung cancer) previously progressing on CPI and treated with ANV600 monotherapy at 120 µg/kg Q2W. Partial responses (PRs) were reported for two patients treated respectively with 30 µg/kg and 60 µg/kg ANV600 Q2W in combination with pembrolizumab Q3W,
Patients experienced target lesion shrinkage in 29% of patients receiving ANV600 monotherapy and 24% of patients receiving ANV600 plus pembrolizumab,
Disease control defined as Complete Response, Partial Response, or Stable Disease observed in 42% of patients treated with ANV600 monotherapy and 59% of the patients receiving ANV600 and Pembrolizumab,
Recommended Phase 2 dose of 90 µg/kg weekly for 4 weeks followed by 150 µg/kg Q2W established,
Patients Treatment with ANV600 resulted in higher absolute counts of CD8+ T cells and NK cells over regulatory T cells.
"Patients with advanced solid tumors treated with ANV600 derived meaningful clinical benefit, with approximately 24% of patients achieving a Complete Response, Partial Response or durable Stable Disease maintained for at least 18 weeks (≥3 tumor assessments)," said Prof. Dr. med. Markus Jörger of Health Ostschweiz (HOCH) in St. Gallen (Switzerland). "The trial provided a valuable treatment option for patients whose disease had progressed beyond available therapies. ANV600 demonstrated a promising safety-efficacy profile, together with compelling proof-of-mechanism in patients with advanced solid tumors."
ASCO Annual Meeting abstracts may be accessed online via View Source
Presentation Details:
Title: Safety, PK/PD, and efficacy results from Expand-1: A phase 1 dose escalation study of the novel PD-1 targeted IL-2R-βγ agonist sunekafusp alpha (ANV600) as a single agent and in combination with pembrolizumab in patients with advanced solid tumors.
First Author: Markus Joerger
Abstract number: 2587
Session Title: Development Therapeutics- Immunotherapy
Poster board: 377
Location, Date and Time: Hall A, May 30, 2026, 1:30 to 4:30 pm, CDT
"With established clinical benefits and strong interest from current clinical investigators, we believe that ANV600 is ideally suited for a partner with the resources and expertise to bring it forward in CPI-resistant NSCLC and other immuno-oncology indications," added Thaminda Ramanayake, Chief Executive Officer of Anaveon.
Anaveon’s proprietary oncology product portfolio is built around a non-blocking PD-1 targeted cytokine platform. This highly selective "cis-signaling" proximity-activated delivery of cytokines is precise and combinable with Check Point Inhibitors. In addition to ANV600, the platform includes ANV700, a preclinical proximity-activated PD-1-targeted IL-21 fusion protein with potential for synergistic effects when combined with IL-2-based approaches and another undisclosed preclinical program. Included in the oncology portfolio is ANV419, an earlier generation (non-PD-1-targeted) IL-2/anti-IL-2 fusion protein with demonstrated safety in prior clinical studies.
The company is now prioritizing its core immunology pipeline and is open to various partnering structures (license, co-development, or acquisition) for the oncology platform and portfolio.
(Press release, Anaveon, MAY 28, 2026, View Source [SID1234666183])