Coya Therapeutics Presents New Experimental Data Supporting the Mechanism of Action of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS) at the 22nd Annual Northeast ALS (NEALS) Consortium Meeting
- Experimental data highlights positive effect of COYA 302 in reducing inflammation in ALS patients
- None.
- COYA 302 is an investigational and proprietary biologic combination with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages;
- COYA 302 is comprised of proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig, and is being developed for subcutaneous administration for the treatment of patients with ALS;
- The experimental data generated in cell samples from ALS patients highlight the significant positive effect of LD IL-2/CTLA4-Ig and other Treg-enhancing therapies in reducing the inflammatory environment observed in ALS. It is known that the degree of neuroinflammation directly correlates with the severity and rate of progression observed in ALS;
- Coya is actively planning its next clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS.
Results of the in vitro study in samples from ALS patients highlight the deleterious role of M1 pro-inflammatory monocytes and macrophages in the ability of Tregs to maintain their immunomodulatory anti-inflammatory function and achieve immune homeostasis. Tregs are often dysfunctional in ALS, exhibiting low anti-inflammatory suppressive function. The degree of impaired Treg function has been shown to directly correlate with the severity and rate of progression of this life-threatening disease.
Prior studies conducted by Dr. Appel and his team at the Houston Methodist Hospital demonstrated that dysfunctional Tregs from ALS patients can be successfully expanded ex vivo restoring their suppressive function, but when Tregs were infused back to the patients the anti-inflammatory function had limited duration. Subsequent studies have identified that the inflammatory environment created by myeloid cells could be a key contributor to the loss of Treg suppressive function.
The present in vitro research work studied the interactions between expanded Tregs and activated monocytes and macrophages, and the ability of immunomodulatory drugs and other Treg-enhancing therapies to increase Treg anti-inflammatory function and suppress the pro-inflammatory function of the M1 phenotype of activated monocytes and macrophages.
Main results of the study are summarized below:
- M1 activated monocytes and macrophages reduce Treg viability and upregulate apoptosis markers.
- Immunomodulatory drugs known to suppress the M1 phenotype significantly decreased the production of inflammatory cytokines involved in tissue damage.
- The combination of LD IL-2/CTLA4-Ig significantly decreased the M1 phenotype and cytokine production and maintained Treg viability.
Results of this study further support the potential of COYA 302 (LD IL-2 and CTLA4-Ig) to address the multiple pathways involved in the progression and severity of ALS. Coya is working expeditiously in the planning and execution of its next clinical study to evaluate the efficacy and safety of COYA 302 in patients with ALS.
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Source: Coya Therapeutics, Inc.
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