Ascendis Pharma, a biopharmaceutical company, announced the submission of an investigational new drug (IND) application with the US Food & Drug Administration (FDA) to initiate IL ßelie?e (I’ll Believe) Trial, a phase 1/2 clinical trial to evaluate TransCon IL-2 ß/? in patients with advanced cancer. TransCon IL-2 ß/? is an investigational long-acting prodrug designed to improve cancer immunotherapy by sustained exposure to an IL-2 variant that selectively activates the IL-2Rß/?, with minimal binding to IL-2Ra.

“This IND submission for our second clinical stage oncology product candidate represents another major milestone for Ascendis. Our understanding of the biology has guided us in designing a novel parent drug, which we have combined with our clinically validated TransCon platform. We believe this combination has the potential to overcome the known shortcomings of current IL-2 compounds, such as low potency, short half-life and high Cmax. By solving the different elements related to efficacy and safety independently, we believe it will be possible to realize the full potential of the IL-2 pathway and create a potentially best-in-class cancer immunotherapy product,” said Kennett Sprogøe, Ph.D., Ascendis Pharma’s Head of Innovation and Research.

TransCon refers to “transient conjugation.” Ascendis Pharma’s proprietary TransCon platform is an innovative technology used to create new therapies that are designed to potentially optimize therapeutic effect, including efficacy, safety, and dosing frequency. TransCon molecules have three components: a parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic conditions (eg, pH and temperature) initiate the release of the active, unmodified parent drug in a predictable manner, maintaining its original mode of action. TransCon technology can be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and can be used systemically or locally.