Through the collaboration, the Alliance will initiate a multi-center Phase II study for the investigational use of Kazia’s investigational new oncology drug, GDC-0084 for the treatment of brain metastases. Considered a ‘bucket study’ the Alliance will also incorporate two with other undisclosed investigational oncology drugs in the research protocol.
Kazia’s investigational drug GDC-0084 is a small molecule inhibitor of the PI3K/AKT/ mTOR pathway which was licensed from Genentech in 2016 and entered a Phase II clinical trial in 2018.
The Alliance, based in the US, has a cancer research network sponsored by the National Cancer Institute. Per the collaboration, it is expected to recruit patients of which many have had cancer that has metastasized to the brain and have a genetic alteration in the PI3K pathway to receive GDC-0084.
Kazia stated that up to 30% of patients with metastatic cancer will develop metastases in the brain. The company added that it is estimated that 200,000 new cases of brain metastases occur each year in the US and the genetic profile of the tumor is an important component in research.
James Garner, CEO of Kazia, told us, “Patients will be selected on the basis of the genetic profile of the tumor, which is a very cutting-edge approach. Depending on the genetic profile, they will be allocated to receive one of three different drugs, each from different companies. Kazia’s drug is the only one targeting genetic mutations in the PI3K pathway that is able to cross the so-called blood-brain barrier, so it has been selected for patients with that particular genetic profile.”
He added, “we are starting to recognize that understanding the genetic profile of a tumor is critical to treating it effectively, but this study is right out in front in terms of putting that into practice.”
The study is expected to take two years to complete under an investigator investigational new drug (IND) application with the US Food and Drug Administration with regulatory responsibilities assumed by the Alliance. Kazia will provide support through a financial grant.