Monash invention progresses to Phase 3 clinical trial for treatment of advanced breast cancers

Monash invention progresses to Phase 3 clinical trial for treatment of advanced breast cancers.
18 September 2025

In a rare and significant milestone for an Australian-discovered therapy, Pfizer Inc has commenced a Phase 3 clinical trial to study a potential new medicine for advanced breast cancer, based on pioneering research from Monash University and the Cancer Therapeutics Cooperative Research Centre (CTx).

The first-in-class therapy is being studied as a treatment in adults with HR+, HER2- advanced or metastatic breast cancer whose disease progressed following prior treatments.

The potential medicine, referred to as ‘PF-07248144’ and co-invented by scientists from the Monash Institute of Pharmaceutical Sciences (MIPS), blocks two proteins – KAT6A and KAT6B – which help control how genes are switched on and off. Because these proteins influence how cells grow and develop, finding ways to block them can ‘turn
down the volume’ on those genes and slow the cancer's ability to grow and spread.

The advancement to Phase 3 clinical trials is supported by highly encouraging Phase 1 results, where PF-07248144, in combination with fulvestrant (a type of hormone therapy), achieved a 37 per cent objective response rate in patients.

The KAT6 platform was licensed to Pfizer through the CTx’ commercialisation partner Oncology One in 2018, and Pfizer progressed the program to ultimately deliver PF-07248144. From MIPS, the project was co-led by medicinal chemists, Professor Paul Stupple and  Dr Ylva Bozikis. Professor Susan Charman also played a critical role in the development of the KAT6 inhibitors through the Centre for Drug Candidate Optimisation.

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