Actigen

Actigen is a United Kingdom-based clinical-stage biopharmaceutical company headquartered in Cambridge. It focuses on the identification and early development of biological medicines for human diseases with unmet medical needs, with a particular emphasis on rare diseases. The company describes itself as patient-focused, aiming to improve outcomes and quality of life for patients and their families through carefully designed clinical trials. Actigen operates as a subsidiary of Affitech Research AS, which supports its activities as it builds a pipeline around clinical trials in the UK, Europe, the United States, and other major markets. The company's team has prior experience developing therapeutic agents with Roche and Generium, and it maintains a long-standing partnership with Generium. Actigen's lead program is GNR-055, a recombinant fusion protein being developed in collaboration with Generium for the treatment of mucopolysaccharidosis II (MPS II, also known as Hunter syndrome). GNR-055 is designed as a fusion protein of iduronate-2-sulfatase (IDS) linked to an antibody fragment that binds to the insulin receptor, enabling transport across the blood-brain barrier. This approach aims to address the progressive neurological impairment associated with MPS II that current enzyme replacement therapy cannot treat. The company is conducting a patient-focused clinical trial evaluating the efficacy, safety, and tolerability of GNR-055 in MPS II patients. Actigen emphasizes collaborative relationships with patient advocacy groups, pharmaceutical partners, and stakeholders, employing creative trial designs based on sound scientific principles to accelerate clinical trials and promote successful outcomes.

Actigen is a clinical-stage biopharmaceutical company based in Cambridge, United Kingdom. It operates as a subsidiary of Affitech Research AS. The company was established to focus on the identification and early development of biological medicines for human diseases with unmet medical needs, particularly rare diseases. The team at Actigen has prior experience in the development of therapeutic agents, having previously worked with Roche and Generium. This experience has informed the company's approach to clinical trial design and its collaborative model. Actigen has built a long-standing partnership with Generium, a leading biologicals developer in Russia with a portfolio of approved medicines and a focus on orphan medicines. Actigen's primary program is GNR-055, a recombinant fusion protein developed in collaboration with Generium for the treatment of mucopolysaccharidosis II (MPS II, Hunter syndrome). GNR-055 is designed to address the limitations of current enzyme replacement therapy, which cannot treat the progressive neurological impairment associated with MPS II because iduronate-2-sulfatase (IDS) is a large molecule that cannot cross the blood-brain barrier. Scientists designed GNR-055 as a fusion protein of IDS linked to an antibody fragment that binds specifically to the insulin receptor on blood capillaries, allowing transport across the blood-brain barrier via IV infusion. The company is conducting a patient-focused clinical trial evaluating the efficacy, safety, and tolerability of GNR-055 in MPS II patients. Actigen emphasizes collaboration with patient advocacy groups and pharmaceutical partners, and employs creative trial designs to expedite trials and promote successful outcomes. The company operates in the UK, Europe, the US, and other major markets.

Patient-focused clinical-stage biopharmaceutical company specializing in rare diseases and innovative trial designs for biological medicines.

• GNR-055

  A recombinant fusion protein of iduronate-2-sulfatase (IDS) linked to an antibody fragment targeting the insulin receptor, designed to cross the blood-brain barrier for the treatment of mucopolysaccharidosis II (MPS II, Hunter syndrome). Developed in partnership with Generium.

1. 1Homepage - Actigenactigen.com
2. 2About - Actigenactigen.com
3. 3Clinical Trials - Actigenactigen.com
4. 4Actigen (United Kingdom) - Wikidatawikidata.org