PIPELINE

We target autoinflammatory and autoimmune diseases with high unmet medical need for which only limited treatment options exist. This includes Graft-versus-Host Disease (GvHD) and autoimmune diseases.

Current Status

CELL THERAPIES

Development

Preclinical

Phase 1

Phase 2

Phase 3

Devel.
Preclinic.
Ph. 1
Ph. 2
Ph. 3
ATreg/Actileucel (ATX-002) | GvHD – EudraCT 2021-006490-32
ATreg/Actileucel (ATX-002) | Autoimmune disease (undisclosed)

BIOLOGICS

Development

Preclinical

Phase 1

Phase 2

Phase 3

Devel.
Preclinic.
Ph. 1
Ph. 2
Ph. 3
ATX-003 | Autoimmune diseases

ATreg/Actileucel (ATX-002)
(prevention of GvHD)

Allogeneic cell therapy.

Ongoing clinical phase Ib/II trial to explore safety and feasibility of ATreg/Actileucel (ATX-002) early after HSCT. The trial is being performed in four German clinical sites and is expected to deliver first results by Q3/2025 (EudraCT 2021-006490-32).

ATreg/Actileucel (ATX-002) has received orphan drug designation (ODD) for use after stem cell transplantation by EMA and FDA.

ATreg/Actileucel (ATX-002)
(treatment of autoimmune diseases)

Allogeneic cell therapy.

Treg are known to have tissue-reparing capability and to have positive impact on autoimmune diseases.

With own research ActiTrexx has gathered comprehensive data to support the application of ATreg/Actileucel (ATX-002) for the treatment of autoimmune diseases.

Biologic
ATX-003

Biologic.

The recombinant protein ATX-003 binds to CD4 and specifically activates Treg.

ATX-003 is being developed for in-vivo activation of the patient’s own Treg to treat autoimmune diseases in combination therapy. It strongly enhances the efficacy of disease-modifying drugs (DMDs). The preclinical development is ongoing.