SYDNEY, Sept. 29,
2023 /PRNewswire/ -- Kazia Therapeutics Limited
(NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development
company, is pleased to announce that data from an ongoing Phase II
study (PNOC022, NCT05009992) of paxalisib, an investigational drug
for the treatment of diffuse intrinsic pontine glioma (DIPG) and
other diffuse midline gliomas (DMGs), sponsored by the Pacific
Pediatric Neuro-Oncology Consortium (PNOC), has been awarded a late
breaking oral presentation at the 2023 Society for Neuro-Oncology
(SNO) Annual Meeting.
SNO exists to advance multi-disciplinary brain tumour research,
education, and collaboration to drive discovery and improve patient
care. The 28th Annual Meeting of the Society for Neuro-Oncology
will take place from November 15 - 19,
2023 in Vancouver,
Canada.
In line with conference publication guidelines, Late-Breaking
Abstracts, for which no more than six will be selected, will be
made public at 7:00 AM (EST) on the
first day of the scientific meeting, Friday,
November 17, 2023 and at
https://academic.oup.com/neuro-oncology/supplements.
Kazia Chief Executive Officer, Dr John
Friend commented, "The Society for Neuro-Oncology conference
is a high-profile meeting where many of the best ideas are
discussed in brain tumour research. We are very excited that the
abstract from the PNOC022 study has been selected for oral
presentation in this forum and look forward to sharing data with
our shareholders and the market in due course."
About the PNOC phase II study
The PNOC022 Phase II study is sponsored by PNOC, an
international consortium focused on the development of novel
combination therapies. It is an adaptive platform study that is
examining paxalisib in combination with ONC201, an experimental
dopamine receptor D2 (DRD2) antagonist developed by Chimerix, Inc.
(Durham, NC). PNOC022 is enrolling
children and young adults with diffuse midline gliomas, a category
of brain tumours that includes DIPG. The study includes separate
cohorts comprising newly diagnosed patients, patients who have
completed initial radiotherapy, and patients who have experienced
disease progression after treatment. The primary endpoint will be
the proportion of patients who are progression-free at six months
(PFS6) for newly diagnosed patients, and overall survival (OS) for
recurrent patients.
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA) is an
oncology-focused drug development company, based
in Sydney, Australia.
Our lead program is paxalisib, a brain-penetrant inhibitor of
the PI3K / Akt / mTOR pathway, which is being developed to
treat multiple forms of brain cancer. Licensed from Genentech in
late 2016, paxalisib is or has been the subject of ten
clinical trials in this disease. A completed Phase II study
in glioblastoma reported promising signals of clinical
activity in 2021, and a pivotal study in glioblastoma,
GBM AGILE, is ongoing, with final data expected in CY2023.
Other clinical trials are ongoing in
brain metastases, diffuse midline gliomas,
and primary CNS lymphoma, with several of these having
reported encouraging interim data.
Paxalisib was granted Orphan
Drug Designation for glioblastoma by the US FDA in February 2018, and Fast
Track Designation for glioblastoma by the FDA in August 2020. Paxalisib was also awarded Fast
Track Designation (FTD) in July 2023
for the treatment of solid tumour brain metastases harboring PI3K
pathway mutations in combination with radiation therapy. In
addition, paxalisib
was granted Rare Pediatric Disease
Designation and Orphan Drug
Designation by the FDA for diffuse
intrinsic pontine glioma in August 2020,
and for atypical teratoid / rhabdoid tumours
(AT/RT) in June 2022 and July 2022,
respectively.
Kazia is also developing EVT801, a small-molecule inhibitor of
VEGFR3, which was licensed from Evotec SE in April 2021. Preclinical data has shown EVT801 to
be active against a broad range of tumour types and has provided
compelling evidence of synergy with immuno-oncology agents. A Phase
I study commenced recruitment in November
2021.
For more information, please
visit www.kaziatherapeutics.com or follow
us on Twitter @KaziaTx.
Forward-Looking Statements
This announcement may contain forward-looking statements, which
can generally be identified as such by the use of words such as
"may," "will," "estimate," "future," "forward," "anticipate," or
other similar words. Any statement describing Kazia's future plans,
strategies, intentions, expectations, objectives, goals or
prospects, and other statements that are not historical facts,
are also forward- looking statements, including, but not
limited to, statements regarding: the timing for results and data
related to Kazia's clinical and preclinical trials, including
PNOC022, and Kazia's strategy and plans with respect to its
programs, including paxalisib and EVT801. Such statements are based
on Kazia's current expectations and projections about future events
and future trends affecting its business and are subject to certain
risks and uncertainties that could cause actual results to differ
materially from those anticipated in the forward-looking
statements, including risks and uncertainties: associated with
clinical and preclinical trials and product development, related to
regulatory approvals, related to Kazia's executive leadership
changes, and related to the impact of global economic conditions.
These and other risks and uncertainties are described more fully in
Kazia's Annual Report, filed on form 20-F with the United States
Securities and Exchange Commission (SEC), and in subsequent filings
with the SEC. Kazia undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events, or otherwise, except as required under applicable
law. You should not place undue reliance on these forward-looking
statements, which apply only as of the date of this
announcement.
This announcement was authorized for release by Dr John Friend, CEO, on behalf
of Kazia's Board of Directors.
For More Information, Please Contact:
Jane Lowe
IR Department
jane.lowe@irdepartment.com.au
Phone: +61 411 117 774
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SOURCE Kazia Therapeutics Limited