SYDNEY, Dec. 1, 2022
/PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX:
KZA), an oncology-focused drug development company, is pleased to
announce the publication of positive preclinical data for EVT801, a
clinical-stage drug candidate currently in a clinical trial for
multiple forms of cancer.
The publication, by Michael Paillasse and colleagues, summarizes
a large body of preclinical research conducted principally by
scientists at Evotec SE and at the University Cancer Institute of
Toulouse - Oncopole over a period of several years. It is now
published in Cancer Research Communications, a
recently-launched journal published by the American Association of
Cancer Research (AACR). The data formed the basis of Kazia's
in-licensing of EVT801 from Evotec in 2021 and has since supported
transition of the compound into an ongoing phase I clinical trial
in patients with advanced solid tumors.
Key Points
- EVT801 is a selective inhibitor of vascular endothelial growth
factor receptor 3 (VEGFR3). VEGFs and VEGFRs are well-validated
cancer drug targets with multiple FDA-approved products directed to
them, but a more selective VEGFR3 inhibitor, such as EVT801, may
result in better tolerability and less development of resistance to
therapy.
- EVT801 was confirmed in preclinical studies to be a potent and
selective inhibitor of VEGFR3, with activity in the low nanomolar
range. The drug was shown to inhibit the formation of lymphatic
vessels in vitro, confirming its intended primary mode of
action.
- In vivo (animal) experiments showed EVT801 to be more
active than both pazopanib (Votrient®, Novartis) and sorafenib
(Nexavar®, Bayer) in the tumor models under investigation.
- EVT801 combined with immune checkpoint inhibitors in mouse
models of several tumor types showed strongly synergistic activity,
with the combination performing better than either drug alone.
Immune checkpoint inhibitors are widely used in many cancers, and
the class includes drugs such as pembrolizumab (Keytruda®, Merck),
nivolumab (Opdivo®, Bristol Myers Squibb), and ipilimumab (Yervoy®,
Bristol Myers Squibb).
"These data demonstrate the substantial potential of EVT801 as a
cancer therapeutic," stated Dr Michael
Paillasse, lead author of the publication. "EVT801 has been
shown to act exactly as intended: by impacting the vasculature in
and around the tumor. In addition, the evidence of synergy with
immunotherapy is persuasive, and we see a considerable opportunity
to combine the drug with immune checkpoint inhibitors in clinical
trials."
"We are grateful that the results of this public-private
translational research initiative have been appreciated by the
editors and reviewers of Cancer Research Communications. We
will now focus on the clinical development," said Professor
Jean-Pierre Delord, co-author and
CEO of the IUCT – Oncopole.
"We are delighted to see this exciting and comprehensive body of
work now published in a leading peer-reviewed journal," said Dr
James Garner, Chief Executive
Officer of Kazia. "The data supports our decision last year to
in-license EVT801, and clearly points to the future development
strategy for the drug. Our collaboration with the Evotec team has
already been extremely fruitful, and we look forward to continuing
to work together on this very promising drug candidate."
The publication may be accessed via the journal website at
https://aacrjournals.org/cancerrescommun/article/2/11/1504/711325/Targeting-Tumor-Angiogenesis-with-the-Selective.
Phase I Clinical Trial
Progressing
EVT801 is currently the subject of an ongoing phase I clinical
trial as monotherapy in patients with advanced solid tumors
(NCT05114668). The study is progressing as planned, with patients
currently being dosed within the anticipated therapeutic range. It
is expected that initial data from this study will be available in
1H CY2023.
For More Information, Please Contact:-
Jane Lowe
IR Department
jane.lowe@irdepartment.com.au
Phone: +61 411 117 774
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 efficacy 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.
About IUCT-Oncopole
The IUCT-Oncopole, a cancer care, research and training center
in Toulouse, combines the expertise of 1,800 professionals on a
single site labeled "Comprehensive Cancer Center". It combines
several state-of-the-art clinical facilities for the treatment of
cancer with a world-class research infrastructure, on an integrated
campus that brings together public and private stakeholders,
including industrial partners. The IUCT-Oncopole, which includes
the Claudius Regaud Institute (ICR) and several teams from the
Toulouse University Hospital, treats more than 10,000 new patients
every year, and more than one in eight patients is enrolled in
clinical studies. Visit https://news.iuct-oncopole.fr/ for
more.
This document was authorized for release to the ASX by
James Garner, Chief Executive
Officer, Managing Director.
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 Kazia's strategy and
plans with respect to its programs, including paxalisib and EVT801.
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, and the 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 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.
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