Aulos Bioscience is developing imneskibart (AU‑007), an AI‑designed human monoclonal antibody that blocks interleukin‑2 binding to the CD25 subunit on regulatory T cells while preserving its activity on CD8⁺ effector cells. By shifting IL‑2 signaling toward immune activation and away from suppression, the therapy aims to deliver safer, more potent immunotherapy for patients with unresectable or metastatic solid tumors, with subcutaneous dosing and reduced vascular leak toxicity.
Funding
$20M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Current interleukin‑2 (IL‑2) therapies for cancer trigger both immune activation and regulatory T‑cell expansion, leading to limited efficacy, severe toxicities such as vascular leak syndrome, and suboptimal dosing regimens. This hampers the ability to safely harness IL‑2’s anti‑tumor potential in patients with solid tumors.
Solution
Aulos Bioscience has engineered imneskibart (AU‑007), a human monoclonal antibody that selectively blocks the IL‑2 interaction with the CD25 subunit on regulatory T cells while preserving IL‑2 binding to CD8 effector cells. By preventing regulatory T‑cell expansion, the antibody shifts IL‑2 activity toward tumor‑killing immune cells, reducing the risk of vascular leak and pulmonary edema. The molecule is designed using an AI‑driven antibody design platform, ensuring high developability, favorable pharmacokinetics, and a long serum half‑life for convenient dosing. Imneskibart is administered subcutaneously in combination with low‑dose IL‑2, delivering a safer, more potent immunotherapy for patients with unresectable or metastatic solid tumors. Early clinical data show deep, durable tumor shrinkage in CPI‑refractory melanoma and objective responses in non‑small cell lung cancer, supporting its potential as a best‑in‑class IL‑2 therapeutic.
Target Audience
Primary customers are oncology pharmaceutical developers and clinical trial sponsors seeking novel immuno‑oncology agents, as well as oncologists treating patients with advanced solid tumors who require effective, low‑toxicity immunotherapies.
Features
- AI‑guided design of a fully human IgG antibody that blocks IL‑2 binding to CD25 while retaining affinity for CD8‑targeted IL‑2 receptors
- Selective inhibition of regulatory T‑cell expansion, enhancing CD8⁺ T‑cell, NK, and NKT cell anti‑tumor activity
- Favorable pharmacokinetic profile with extended serum half‑life, enabling less frequent subcutaneous dosing
- Demonstrated safety and early anti‑tumor efficacy in Phase 1/2 trials for melanoma, renal cell carcinoma, and NSCLC
- Manufacturable as a standard monoclonal antibody with established production and formulation processes
- Compatible with combination regimens, such as low‑dose aldesleukin or checkpoint inhibitors, to further boost efficacy