Other presentations and publications of
GDC-0084
data are
anticipated in the next six to twelve months, and the Kazia team will be discussing appropriate opportunities with investigators at the upcoming SNO meeting.
Manufacturing
Work has begun to manufacture a
second batch of capsules for use across the
GDC-0084
clinical program, under international Good Manufacturing Practice (GMP) conditions. The company obtained approximately 48kg of drug substance as part of its
transaction with Genentech in October 2016, and this remains highly stable. Kazia has planned to periodically formulate a portion of this material into capsules for clinical trial use, according to progress with the studies. Given the pace of
recruitment to date, it has been considered appropriate to accelerate manufacture of a second batch of capsules to ensure continuity of supply. Production of a second batch will also strengthen the data available regarding
GDC-0084
manufacture for regulatory purposes, and will ultimately help to inform commercial supply.
Regulatory
Affairs
In accordance with FDA requirements, Kazia has been undertaking a
13-week
toxicology study of
GDC-0084
in two animal species. This is a routine requirement to support long-term use of the drug in human patients. The study is progressing well according to plans, and is on track to conclude before the end of
calendar 2018.
Kazia has applied to the World Health Organisation (WHO) for an International
Non-proprietary
Name
(INN) for
GDC-0084.
It is common for drugs to be referred to by a code number during early development, but companies typically seek allocation of an INN around the initiation of phase II development. INNs are
a necessary step for eventual regulatory approval and are determined centrally by WHO. Kazia expects to receive the INN for
GDC-0084
in late calendar 2019.
Intellectual Property
Since assuming
responsibility for
GDC-0084
from Genentech in October 2016, Kazia has continued to pursue robust protection for the intellectual property associated with the drug. Of note, patents have been granted in
Australia (July 2017), the Peoples Republic of China (March 2018), Hong Kong SAR (March 2017), and the United States (January 2017), as well as in a number of other jurisdictions. In general, the patents relating to
GDC-0084
provide comprehensive protection until at least 2031.
[ENDS]
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 multiforme, 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 March 2018. Initial data is expected in early calendar 2019.
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. Initial data was presented in
June 2018 and the study remains ongoing. Cantrixil was granted orphan designation for ovarian cancer by the US FDA in April 2015.