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'We believe that COYA 301 is ideally situated to serve as a backbone drug in combination with other biologics that synergistically modulate the immune system and represent next generation approaches to treating inflammatory disorders, which are driven by complex and multi-factorial pathways. Enhancing Treg activity with COYA 301 in combination with GM-CSF and additional immune analogues creates yet another novel biologic combination in addition to Coya's lead asset, COYA 302 and expands optionality and potential partnerships,' stated
GM-CSF is a potent immune modulator known to promote Treg activities and dampen pro-inflammatory T effector responses, and ld IL-2 is a cytokine that enhances Treg function and numbers. Preclinical data (here) generated by the Gendelman laboratory at UNeMed demonstrated that the combination of ld IL-2 + GM-CSF generated a synergistic increase in Tregs in mice tissue, including in peripheral blood, spleen, and lymphoid cells. This included a 4-to-6-fold higher expression of Tregs in mice treated with the combination compared to treatments with either cytokine alone. Other markers that indicate a suppressive Treg phenotype were dramatically increased as well, including a 4-fold increase in CD25+CD127low cells and a synergistic increase in the percentages of CD25+CD4+ Tregs that express CD39+, ICOS+ markers, and GITR+.
About
About COYA 302
COYA 302 is an investigational and proprietary biologic combination therapy 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. These mechanisms may have additive or synergistic effects.
In February of 2023, Coya announced results from a proof-of-concept, open-label clinical study evaluating LD IL-2 and CTLA-4 Ig in a small cohort of patients with ALS conducted at the
During the 48-week treatment period, the therapy was well tolerated. The most common adverse event was mild injection-site reactions. No patient discontinued the study, and no deaths or other serious adverse events were reported.
Patients' disease progression was measured using the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean (+/-SD) ALSFRS-R scores at week 24 (33.75 +/-3.3) and week 48 (32 +/-7.8) after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline (33.5 +/-5.9), suggesting significant amelioration in the progression of the disease over the 48-week treatment period.
Treg suppressive function, expressed as percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period. Treg suppressive function at 24 weeks (79.9 +/-9.6) and 48 weeks (89.5 +/-4.1) were significantly higher compared to baseline (62.1 +/-8.1) (p
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