Sparks - Oryzon Genomics

Oryzon Genomics has announced dosing of the first patient in an investigator-initiated Phase Ib trial evaluating iadademstat, its selective LSD1 inhibitor, in combination with radiotherapy and the immune checkpoint inhibitor atezolizumab for patients with residual, progressive, or recurrent extensive-stage small cell lung cancer (ES-SCLC). The study, led by Yale University, will assess the safety, tolerability and preliminary efficacy of this triplet regimen in a heavily pre-treated patient population. This is in line with management’s aim to build an extensive data package for iadademstat (it is being tested in several trials across multiple oncology indications such as acute myeloid leukaemia (AML) and SCLC)) to support its efforts in seeking a partner for the asset, as the company repositions itself as a central nervous system (CNS) focused play with lead asset vafidemstat.

The company has previously announced the receipt of a ‘Decision to grant’ from the Japanese Patent Office for its patent application ‘Methods of treating behavior alterations’ for vafidemstat. This covers the use of vafidemstat for the treatment of aggression and social withdrawal, two of the symptoms associated with several CNS disorders. Once granted, the patent will provide market exclusivity until at least 2038, excluding any other potential patent term extensions. We note that vafidemstat has already secured corresponding patents in Europe, Australia, Canada, Hong Kong, Israel, South Korea, Malaysia, the Philippines and Russia, with additional applications pending in other key regions. We see the most significant upcoming catalyst for Oryzon to be the upcoming Phase III trial evaluating vafidemstat in borderline personality disorder (expected in 2026).