Cue Biopharma, Inc., a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells, has announced preclinical safety and tolerability data that further supports the preclinical profile of CUE-401, the Company’s lead autoimmune asset.
In two non-GLP studies, CUE-401 was well tolerated with no adverse events observed. These proof-of-concept studies reinforce the promising preclinical profile and therapeutic potential of the drug.
Azam added that the company looks forward to sharing further scientific data and details on the planned investigational new drug (IND) filing for CUE-401 in the upcoming months.
About CUE-401
CUE-401 is a novel bifunctional therapeutic that incorporates an innovative TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin 2 (IL-2) mutein in a single injectable biologic.
The design of CUE-401 was inspired by Nobel Prize-winning science regarding the role of IL-2 and TGF-beta as essential components in helping establish immune tolerance by regulating FOXP3 signaling. CUE-401 is designed to promote immune regulation and tolerance by three complementary mechanisms:
- Direct regulation of proinflammatory mechanisms by TGF-beta.
- Expansion of existing Tregs by IL-2.
- Conversion of FOXP3- conventional CD4+ T cells into FOXP3+ induced Tregs through the coordinated provision of TGF-beta and IL-2 signals, both of which are required for the de novo induction of FOXP3 expression.
About Cue Biopharma
Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation.
