KZIA Kazia Therapeutics Ltd

ASX RELEASE

20 May 2019

KAZIA ENTERS CLINICAL COLLABORATION FOR METASTATIC BRAIN CANCER WITH ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY

Sydney, 20  May 2019 – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that it has entered into a collaboration with the Alliance for Clinical Trials in Oncology Foundation (Alliance), a US-based cancer research network sponsored by the National Cancer Institute. Alliance will launch a multi-centre phase II study to investigate the potential use of Kazia’s investigational new drug, GDC-0084, alongside several other targeted cancer therapies, in the treatment of brain metastases (cancer that has spread to the brain).

“Brain metastases truly represent an unmet clinical need,” said Priscilla Brastianos, MD, Principal Investigator of the study, and Assistant Professor of Medicine at Harvard Medical School. “We urgently need to find better treatment options for these patients. We hope this study will help us identify a new treatment paradigm.” Dr Brastianos is also an Assistant Physician in Medicine in the Department of Hematology/Oncology at Massachusetts General Hospital. Her research interests focus on metastatic brain cancer, and she has been extensively published in this field. Dr Brastianos will be joined on the study Steering Committee by distinguished expert clinicians from leading centres across the United States.

Key Points

Up to 30% of patients with metastatic cancer will develop secondary tumors (metastases) in the brain, and it is estimated that there are approximately 200,000 new cases of brain metastases each year in the United States alone. Treatment options remain limited, and average survival of patients with brain metastases ranges from 3 to 27 months, depending on factors such as the location of the original tumor.

Board of Directors

Mr Iain Ross Chairman, Non-Executive Director

Mr Bryce Carmine Non-Executive Director

Mr Steven Coffey Non-Executive Director

Dr James Garner Chief Executive Officer, Managing Director

It is increasingly recognized that cancer is a complex disease, in which tumors in a similar location (e.g. breast, lung) may respond very differently to treatment. An important factor in this is the genetic profile of the tumor. Clinical studies have begun to focus on carefully allocating patients to treatment on basis of this genetic profile, an approach which is sometimes referred to as ‘precision medicine’ or ‘personalized medicine’. The Alliance study is an example of this approach.

The Alliance study, also known as A071701, is expected to recruit up to 150 patients in total, all of whom will have cancer that has spread to the brain. Only patients with a genetic alteration in the PI3K pathway will receive GDC-0084, and it is expected that approximately one third of the total patients will be in this group. Patients with other genetic mutations will be allocated to receive either abemaciclib, a CDK inhibitor, also known as Verzenio ^™ , that is manufactured by Eli Lilly and has been approved by FDA for the treatment of certain forms of breast cancer, or entrectinib, a Trk/ALK inhibitor manufactured by Genentech, which has not yet been approved by FDA.

Dr James Garner, Chief Executive Officer of Kazia Therapeutics commented, “The Alliance study is a ground-breaking research project that aims to investigate several experimental drugs in a single clinical study. Patients will be allocated to treatment depending on their tumor’s individual genetic signature, and patients with a mutation affecting the PI3K pathway will be eligible to receive GDC-0084. This kind of approach is very much the future of cancer treatment. We are delighted that GDC-0084 has been selected and we are excited to see this study move forward.”

The initiation of the study brings to four the number of ongoing clinical trials with GDC-0084:

It is expected that the study will take approximately two years to complete. Kazia will provide support, including a financial grant to defray a portion of the costs. The study will be conducted under an ‘investigator IND’ with the US FDA, in which the primary regulatory responsibilities for the study will be assumed by Alliance. Implementation of the study is conditional upon approval from applicable Institutional Review Boards, and completion of contractual formalities, and these matters have not yet been finalised. It is expected that the study will begin recruitment in the second half of calendar 2019.

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