Posted: 17 September 2025
Oncology One Pty Ltd reported that Pfizer Inc’s clinical candidate PF-07248144, a first-in-class KAT6 inhibitor originating from Australian research, had entered a Phase 3 clinical trial for hormone receptor positive, HER2-negative breast cancer.
PF-07248144 was described as a selective inhibitor of KAT6A/B, enzymes that regulate gene expression. In cancers where these genes are dysregulated, the drug suppresses abnormal activity and slows tumour growth. Earlier studies indicated promise in advanced or metastatic disease. The KATSIS-1 trial (NCT07062965), listed on clinicaltrials.gov, will evaluate PF-07248144 with fulvestrant in up to 400 patients worldwide, including in Australian hospitals. The achievement was highlighted as a major outcome for Australian collaboration through the Cancer Therapeutics CRC (now Canthera Discovery).
The programme was first licensed into the CRC in 2009 and later out-licensed to Pfizer in 2018 by Oncology One (formerly CTxONE). Professor Ian Street, Chair of Oncology One’s Scientific Advisory Board, said: “In the early 2000s at Walter and Eliza Hall Institute (WEHI), Anne Voss and Tim Thomas made foundational discoveries about KAT6A, a protein that is important for controlling gene expression during development and growth of some blood cancers.
Many CTx research and industry partners – Monash Institute of Pharmaceutical Sciences, SYNthesis Med Chem, Peter MacCallum Cancer Centre, WEHI, CSIRO, Griffith University, St Vincent’s Institute of Medical Research, and the Children’s Cancer Institute, along with Pfizer, have worked together to develop a new drug that targets KAT6.
This is a deeply inspiring story of collaboration in Australia’s medical research sector.” He added: “I would like to congratulate the visionary and talented Australian scientists and clinicians who contributed to the discovery and development of PF-07248144 – and of course, share our sincere gratitude to Pfizer for backing this potential cancer therapeutic so quickly into a Phase 3 Clinical Trial.” If successful, PF-07248144 is expected to inaugurate a new class of therapies that halt cancer cell growth.
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