SYDNEY, June 27,
2024 /PRNewswire/ -- Kazia Therapeutics Limited
(NASDAQ: KZIA), a biotechnology company specialising in oncology,
is pleased to announce the presentation of new data from its lead
program, paxalisib, at the upcoming 21st International Symposium on
Pediatric Neuro-Oncology (ISPNO 2024) June
29 – July 2, 2024, in
Philadelphia, PA. Kazia
concurrently announces publication of an article in European
Journal of Cancer highlighting the need for evaluating
mutation-specific, CNS penetrant, inhibitors to treat pediatric
patients with Diffuse Midline Glioma (DMG).
There will be three paxalisib-related presentations in total at
ISPNO, including data from the Phase 2 PNOC DMG-ACT (DMG-Adaptive
Combination Trial, PNOC022) study evaluating the efficacy and
safety of paxalisib in combination with ONC201. As a follow up to
data presented last year at the Society for NeuroOncology,
28th Annual Meeting, lead researchers will discuss
survival, pharmacokinetics, and tumor biomarkers from 132 diffuse
midline glioma (DMG) patients enrolled in the Phase 2 study.
Highlights of the abstract include median overall survival of 13.2
months in Cohort 1 (newly diagnosed, enrolled pre-radiation n=33),
15.8 months in Cohort 2 (newly diagnosed, enrolled post-radiation
n=69) and 8.8 months in Cohort 3 (relapsed patients, enrolled after
progression n=30).
The second presentation is based on novel preclinical data
utilizing the addition of a novel HDAC inhibitor to the backbone
therapy of paxalisib in DMG models. The third presentation will
highlight preclinical data results of the combination therapy of
paxalisib and gemcitabine for patients with relapsed/recurrent
atypical teratoid/rhabdoid tumors AT/RT by Johns Hopkins University researchers. Based on
these findings, the Pacific Pediatric Neuro-Oncology Consortium is
planning to include this combination therapy in its next AT/RT
international clinical trial.
Summary of Abstracts
(https://virtual.oxfordabstracts.com/#/event/5131/program?program&date=%222024-6-30%22)
Clinical
Trials; July 2, 2024; 8:15am
TRLS-14: PNOC022 report: a combination therapy trial using an
adaptive platform design for patients with diffuse midline glioma
at initial diagnosis, post-radiation therapy, or progression
Cassie Kline, Andrea Franson, Anuradha
Banerjee, Alyssa T Reddy, et al
Poster Session I; June 30, 2024;
5pm
ATRT-15 Combining the PI3K inhibitor paxalisib with nucleoside
analog gemcitabine to improve survival of atypical
teratoid/rhabdoid tumors
Tyler Findlay, Kristen Malebranche,
Anupa Geethadevi, Charles Eberhart,
Jeffrey Rubens, Eric Raabe
DIPG-21 Preclinical assessment of a multimodal treatment
approach with Givinostat, Paxalisib, and radiotherapy for Diffuse
Midline Glioma (DMG)
Aimée du Chatinier, Michaël H Meel, Piotr Waranecki, Dennis S
Metselaar, Esther
The European Journal of Cancer publication titled Paediatric
Strategy Forum for Medicinal Product Development of PI3-K, mTOR,
AKT and GSK3β Inhibitors in Children and Adolescents with Cancer is
the output from a two-day forum in April
2023 at Dana Farber Cancer Institute. Consisting of
patient advocates, regulators, researchers and pediatric
clinicians, the publication concludes "Evaluation of
mutation-specific, CNS-penetrant PI3-K inhibitors in children with
DMG should be prioritised and innovative regulatory approaches are
needed in view of the rarity of the population." The paper can be
accessed at the following website:
https://www.ejcancer.com/article/S0959-8049(24)00801-3/fulltext
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (NASDAQ: KZIA) is an
oncology-focused drug development company, based in Sydney,
Australia. Our lead program is
paxalisib, an investigational 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 2 study in glioblastoma reported early
signals of clinical activity in 2021, and a pivotal study in
glioblastoma, GBM AGILE, has completed enrollment, with final data
expected imminently. 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 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
in June 2022 and July 2022, respectively.
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 and investigator-initiated
trials of Kazia's product candidates, 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, 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.
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