A therapy discovered in Melbourne has moved into Phase 3 clinical trials, a milestone rarely reached by Australian research. Pfizer has begun studying PF-07248144, a potential treatment for HR+, HER2- advanced or metastatic breast cancer, developed from work at Monash University and the Cancer Therapeutics Cooperative Research Centre (CTx).
The medicine targets proteins KAT6A and KAT6B, which influence how genes are activated. By blocking these proteins, researchers believe the therapy can slow the growth and spread of cancer cells. Early trial results have encouraged further progress, with Phase 1 studies showing a 37 per cent response rate when the drug was combined with fulvestrant, a hormone therapy.
The program was co-led at the Monash Institute of Pharmaceutical Sciences (MIPS) by Professor Paul Stupple and Dr Ylva Bozikis. Professor Stupple said the progress reflected years of effort across institutions. “The discovery of PF-07248144 is an important scientific advance. For the first time, selective targeting of KAT6 opens new avenues for the treatment of advanced breast cancers,” he said.
“This program represents what can be achieved through scientific collaboration and uniting diverse expertise. By bringing together skills and knowledge across academia and industry we were able to translate early stage research into a promising new therapy now advancing in clinical trials. Seeing this work benefit patients and progress to Phase 3 trials is a wonderful testament to the impact of true collaboration.”
Professor Susan Charman, who helped develop the KAT6 inhibitors, said the candidate “represents a marked improvement in potency, selectivity, and drug-like properties.”
Patients with HR+, HER2- advanced breast cancer still face challenges with resistance to treatment and disease progression. Professor Brendon Monahan, former Chief Scientific Officer for CTx and now at MIPS, said Pfizer’s trial results offered hope. “Pfizer’s Phase 1 study provided a strong clinical proof of concept that targeting KAT6 offers a novel epigenetic approach for treating patients with breast cancer. The direct advancement to Phase 3 trials underscores the significance of this work and highlights the quality of the contribution from MIPS and the wider CTx group in discovering this first-in-class therapy.”
CTx became Canthera Discovery in 2021. Managing Director Dr Alan Robertson said, “This is a major milestone, and we thank Pfizer for their tireless efforts in advancing the program. Our goal has always been to find new cancer treatment options for patients, and with this announcement, we are one step closer to fulfilling that vision.”
The effort involved researchers across Australia, including teams from MIPS, WEHI, Peter MacCallum Cancer Centre, CSIRO, Griffith University, St Vincent’s Institute of Medical Research, and the Children’s Cancer Institute.
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