SYDNEY, June 8, 2023
/PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX:
KZA), an oncology-focused drug development company, is pleased to
announce that it is supporting the University
of Sydney on a molecularly-guided phase II clinical study to
examine paxalisib in adult patients with recurrent/progressive
isocitrate dehydrogenase (IDH) mutant grade 2 and 3 glioma (G2/3
gliomas).
The study, named LUMOS2, will be sponsored by the University of Sydney, and coordinated by NHMRC
Clinical Trials Centre, University of
Sydney, in collaboration with COGNO (Co-Operative Trials
Group for Neuro-Oncology).
The study team will be led by Professor Hui Gan, Co-Director, Centre for Research
Excellence in Brain Cancer and
research clinician at the Olivia Newton-John Cancer Research
Institute in Melbourne, VIC, who
specializes in the investigation of novel therapies for brain
cancer.
Key Points
- The LUMOS2 study aims to investigate paxalisib and other
targeted therapies in adult patients with grade 2 or 3 IDH-mutant
gliomas. Paxalisib is already the subject of several studies in
high-grade glioma, a category which includes diseases such as
glioblastoma and Diffuse Intrinsic Pontine Glioma (DIPG).
- Grade 2 and 3 gliomas represent a substantial unmet clinical
need, with recurrent patients having a poor prognosis that is
comparable to glioblastoma. The glioma patient population has been
the subject of increasing focus for drug development companies,
including Day One Biopharmaceuticals (NASDAQ: DAWN), Servier and
Novartis (NYSE: NVS).
- LUMOS2, an umbrella study with multiple arms, is expected to
enroll up to 76 patients and will be a multi-centre study at
several Australian sites, with the potential to expand
internationally.
- The study is funded by the Australian Government, through a
Medical Research Future Fund (MRFF) grant, with Kazia's
contribution consisting of study drug supply and in-kind
support.
- "We are delighted to have paxalisib as one of the
interventional arms in the LUMOS 2 study," commented Professor
Hui Gan, lead investigator on the
study. "Relapsed IDH mutant gliomas are an important area of unmet
need in brain cancer, and the LUMOS2 study builds on early phase II
data seen with paxalisib in this population. LUMOS2 will complement
some of the ongoing work with paxalisib evaluating the efficacy of
the drug in high-grade gliomas, and we expect the study to add
substantially to our understanding of this investigational drug in
brain cancer."
Low Grade Glioma
Gliomas are the most common form of primary brain cancer,
accounting approximately for a third of malignancies that originate
in the brain. They are sub-classified into oligodendrogliomas or
astrocytomas, according their morphology and the presence of
characteristic molecular alterations. Grade 2 and 3 IDH mutant
astrocytomas are collectively the next largest group after
glioblastoma, comprising just over 20% of gliomas (with a rate of
0.016 per 2000 patients).
High Grade Gliomas (HGGs) include diseases such as glioblastoma
(grade 4 glioma), and diffuse midline gliomas such as DIPG.
Paxalisib has shown evidence of clinical activity in several forms
of HGG.
G2/3 gliomas remain an area of significant unmet need, with
very few FDA-approved therapies and limited response to repeated
courses of radiotherapy. Whilst the disease is often
well-controlled after first-line standard of care therapies,
patients with recurrent disease unfortunately have a prognosis
comparable to glioblastoma, and current treatment options may offer
only limited effectiveness for these patients.
Clinical Study Design
LUMOS2 is a prospective, multi-centre, open-label, multi-arm,
phase II, biomarker-directed, signal-seeking, umbrella clinical
trial. Adults with progressive grade 2/3, IDH-mutant glioma at
recurrence after prior treatment with radiotherapy and alkylating
chemotherapy who are eligible and willing to undergo tumour
resection in consultation with their treating physician will
undergo molecular profiling, the results of which will serve as a
recommendation to be assigned to a treatment arm. The primary
objective of the study is to determine progression-free survival at
six months (PFS6) with overall survival, response rate and
health-related quality of life as secondary endpoints.
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 for registration, 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 US FDA in
August 2020. In addition, paxalisib
was granted Rare Pediatric Disease Designation and Orphan
Designation by the US FDA for DIPG 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.
This document was authorized for release to the ASX by
John Friend, Chief Executive
Officer.
About the University of Sydney
As Australia's first university
– founded in 1850 – the University of
Sydney has a proud history of global leadership in education
and research and inspiring people from all backgrounds to
contribute to positive real-world change. The University of Sydney is a world-renowned teaching
and research institution with research that combines the expertise
and talents of scholars from many disciplines.
About University of Sydney, NHMRC Clinical Trials
Centre
Based at the University of Sydney,
the NHMRC Clinical Trials Centre designs and manages clinical
trials. This includes responsibility for study coordination,
monitoring, data acquisition and management and statistical
analysis. The health economics, biostatistics, systematic reviews
and biomarker teams at the NHMRC Clinical Trials Centre work with
trial data and inform healthcare providers about best
practice.
COGNO (Co-Operative Trials Group for Neuro-Oncology) and the
NHMRC CTC collaborate to develop and conduct clinical trials that
test interventions designed to improve care and outcomes for people
affected by brain cancer.
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, or third-party trials
evaluating Kazia's product candidates, and Kazia's strategy and
plans with respect to its programs, including paxalisib. Such
statements are based on Kazia's 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, risks related to
Kazia's executive leadership changes, and the related to the impact
of global economic conditions, including disruptions in the banking
industry. These and other risks and uncertainties are described
more fully in Kazia's Annual Report, filed on form 20-F with the
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.
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