Aculeus Therapeutics has announced that it has initiated Investigational New Drug, or IND-enabling, studies for its lead program, STING.
Aculeus has selected its preclinical development candidate, ACU-0943, which activates the STING (stimulator of interferon genes) pathway to boost immune responses to cancer.
CEO Mark Devlin said, “I’m incredibly proud of what the Aculeus team has been able to achieve over the first two years of the life of our company. I’d also like to acknowledge the outstanding input from our local and international team of scientific, regulatory, and clinical advisors that has helped make this rapid progress possible”.
The company said it expects to begin formal GLP (good laboratory practice) toxicology studies in the first quarter of 2023. It is already in communication with the US FDA and is planning to submit a Pre-IND meeting request ahead of the Phase 1 start.
The company said it plans to conduct a multi-centre phase 1a/1b study in Australia commencing in the first half of 2024, if ACU-0943 moves successfully through IND-enabling studies.