aTyr Pharma, Inc., a biotherapeutics company engaged in the discovery and clinical development of innovative Physiocrine-based medicines for patients suffering from severe rare diseases, recently announced that it has designated an Investigational New Drug (IND) candidate. The IND is based on an fibro-modulating and immuno-modulatory Physiocrine domain fused to an Fc region of a human antibody, named iMod.Fc. The clinical aim of the selected iMod.Fc molecule is to treat patients with severe pulmonary diseases presenting a fibrotic and immune component.
“The molecule developed in our iMod.Fc discovery program represents a major breakthrough as the first engineered Physiocrine with advantageous pharmaceutical properties designed into our therapeutic protein, which opens up new possibilities of reaching a more diverse set of patients with severe lung diseases,” said John Mendlein, Ph.D., CEO and executive chairman of aTyr Pharma in a recent press release. “This molecule represents a potential new platform within aTyr. Similar to the process of taking receptor domains and fusing them to Fc regions, we may be able to fuse our Physiocrine ligands to the Fc region to enhance their properties.”
Results derived for preclinical studies have shown that the selected iMod.Fc molecule is promising in a mouse model of lung inflammation and pulmonary fibrosis, produced by bleomycin, a chemotherapeutic agent. When given as treatment in two doses, the iMod.Fc molecule was found to be comparable to, or even to outperform, currently approved drugs in lessening the lung inflammation in the bleomycin mouse model. aTyr is starting GMP process development in collaboration with a third party manufacturer.
The designated iMod.Fc molecule is aTyr’s second therapeutic development candidate based on Physiocrines, described by the company as extracellular signaling regions of tRNA synthetases, an ancient family of enzymes that catalyze a key step in protein synthesis. aTyr has been responsible for the discovery of over 300 Physiocrines with various purposes that have possible clinical applications in variety of medical conditions, such as severe diseases of the lung, skin, liver, muscle, gut and brain.
aTyr is expanding Resolaris™, its first therapeutic drug candidate, to treat patients suffering from rare myopathies with an immune component (RMICs), including limb girdle muscular dystrophy (LGMD) and facioscapulohumeral muscular dystrophy (FSHD). The company plans are on going for the clinical assessment of Resolaris in rare pulmonary conditions with an immune component (RPICs), including interstitial lung diseases (ILDs).
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