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Aculeus Therapeutics announces IND-enabling studies to advance lead program ACU-0943 towards clinical trials

October 03, 2022

MELBOURNE (October 3, 2022) – Aculeus Therapeutics (“Aculeus” or “Company”) is a life sciences company focussed on discovering and developing novel immunotherapies to treat a range of serious diseases. Today, Aculeus announced that it has initiated Investigational New Drug, or IND-enabling, studies for it’s lead program, STING. Aculeus has selected it’s preclinical development candidate, ACU-0943, which activates the STING (stimulator of interferon genes) pathway to boost immune responses to cancer.


Mark Devlin, Aculeus’ CEO, commented “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 expects to begin formal GLP (good laboratory practice) toxicology studies in the first quarter of 2023. Aculeus is already in communication with the FDA and is planning to submit a Pre-IND meeting request ahead of the Phase 1 start. If ACU-0943 moves successfully through IND-enabling studies, as expected, the Company plans to conduct a multi-centre phase 1a/1b study in Australia commencing in the first half of 2024.


About Aculeus Therapeutics


Aculeus Therapeutics is a Biotech company based in Melbourne Australia, developing small molecule drugs that modulate the immune system for the treatment of cancer and other serious diseases. Aculeus is doing this by developing drugs that target the Stimulator of Interferon Genes (STING) biochemical pathway.

Aculeus welcomes the opportunity to work with other companies and research organisations with a shared commitment to scientific excellence and developing new medicines that provide meaningful benefit to people suffering from serious diseases.


For more information, visit or connect with us on Twitter @AculeusTx.

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