ABY-271 & ABY-025

Targeted radiotherapies for tumor diseases

Affibody^® molecules can be attached to radioactive agents. This makes it possible to tailor targeting molecules that, within minutes of being injected into the body, find and bind to a selected surface protein on tumor cells, where they remain for an extended period of time, allowing the radioactive agent to emit its radiation with high precision.

As an added effect, the treatment causes antigen release from the irradiated tumor cells, helping the body’s immune system to raise an immune response to these tumor antigens to detect and kill surviving cancer cells. This mechanism opens interesting possibilities for combination therapies with immuno-oncology drugs.

ABY-025 and GE-226

ABY-025 is a Gallium-68-labeled PET tracer candidate that aims to enable non-invasive and cost-effective PET imaging diagnosis of HER2 expression in cancer patients. HER2 is a receptor protein overexpressed in several different cancer forms, e.g., breast cancer and gastric or gastroesophageal junction cancer.

Affibody is collaborating with esteemed academic institutions to explore the clinical utility of ABY-025. Phase 2 results with ABY-025 indicate that the compound can be used both to detect HER2 expression and monitor therapy response.

In recent years, the interest has increased in treating patients with low HER2 expression and Affibody has successfully shown that it is possible to identify patients with low HER2 expression with ABY-025. Results from a clinical trial demonstrating this have been published in the Journal of Nuclear Medicine (JNM).

To enable a broad market uptake and address the two most important radioisotopes used for PET imaging, Gallium-68 and Fluorine-18, Affibody is collaborating with GE Healthcare, one of the world’s largest medtech companies. GE Healthcare has successfully completed a clinical study in metastatic breast cancer patients and is planning additional clinical studies with GE-226, a Fluorine-18-labeled PET tracer candidate based on the same HER2 targeting Affibody^® molecule as ABY-025.

ABY-271

ABY-271 is a radiotherapeutic candidate aimed at tumor cells that express HER2, regardless of their position in the body. The project builds on previous clinical research insights from the development of ABY-025, showing that the candidate substance can bind to HER2 independently of the tumor origin. ABY-271 emits cytotoxic beta radiation, exerting irreversible damage to the cancer cells upon binding.

The drug candidate is currently in preclinical development.