Edison research report and publication of Genentech phase I results

Edison research on paxalisib (GDC-0084) joining GBM AGILE

We’re pleased to share the latest Edison research report on our lead candidate paxalisib (GDC-0084) joining GBM AGILE, as announced to the ASX in December.

GBM AGILE is an international, academic-led, multi-drug adaptive phase II/III study in glioblastoma which will serve as the path-to-market for paxalisib.

“AGILE has several advantages: a faster start, an existing design and an expanding infrastructure plus involvement of key opinion leaders, a big benefit in the event of positive data, regulatory review and launch,” the report says.

Read the full report here.

Read the ASX Announcement on GBM AGILE here

Results from Genentech phase 1 study of paxalisib published in Clinical Cancer Research

Also, results from Genentech’s phase I study of paxalisib were recently published in Clinical Cancer Research.

The study showed that paxalisib crossed the blood brain barrier, has good PK properties and an acceptable safety profile in patients with progressive or recurrent high-grade glioma.

Read the article here

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an innovative oncology-focused biotechnology company, based in Sydney, Australia. Our pipeline includes two clinical-stage drug development candidates, and we are working to develop therapies across a range of oncology indications.

Our lead program is GDC-0084, a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, GDC-0084 entered a phase II clinical trial in 2018. Interim data was reported in November 2019, and further data is expected in 1H 2020. GDC-0084 was granted orphan designation for glioblastoma by the US FDA in February 2018.

TRX-E-002-1 (Cantrixil), is a third-generation benzopyran molecule with activity against cancer stem cells and is being developed to treat ovarian cancer. TRX-E-002-1 is currently undergoing a phase I clinical trial in Australia and the United States. Interim data was presented at the ESMO Congress in September 2019, and the study remains ongoing. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015.

This announcement was authorized for release to the ASX by James Garner, Chief Executive Officer, Managing Director.