SYDNEY, April 4,
2023 /PRNewswire/ -- Kazia Therapeutics Limited
(NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development
company, is pleased to announce the presentation of new data for
both of its pipeline molecules, paxalisib and EVT801, at the
upcoming Annual Meeting of the American Association for Cancer
Research (AACR), held in Orlando,
FL, from 14 – 19 April
2023.
In total, there will be five presentations at AACR, four of
which build on previous positive data for paxalisib in melanoma and
childhood brain cancer. The new data being presented provide
significant support and direction for the future development of
paxalisib in these expansion indications.
In addition, a presentation by scientists from Kazia's partner,
Evotec, will outline the novel biomarker strategy employed in the
phase I study of EVT801, and anticipates the potential initial
clinical data from EVT801 in CY2023.
Key Points
- Research by Dr Gennie Parkman
and colleagues, working in the laboratory of Professor Sheri Holmen at the Huntsman Cancer Institute at
the University of Utah in Salt Lake City, shows paxalisib leading to
'substantially increased overall survival' in a mouse model of
BRAF-driven melanoma.
- Further data from Dr Tyler
Findlay and Dr Kristen
Malebranche in Professor Jeffery
Rubens' team at Johns Hopkins
University Medical School has shown compelling evidence of
synergy between paxalisib and both gemcitabine, a chemotherapy
agent, and mirdametinib, a targeted therapy, in animal models of
atypical teratoid / rhabdoid tumors (AT/RT), a childhood brain
cancer. This data expands on positive data for paxalisib as
monotherapy and in other combination regimens that was presented at
AACR in 2022. The results suggest potential therapeutic approaches
for use in clinical trials.
- An additional abstract by Dr Hyuk Jean
Kwon and colleagues at Professor Rubens' lab describes in
vitro preclinical data for the combination of paxalisib with a dual
inhibitor of ACVR1 and MEK in diffuse midline gliomas, a category
of childhood brain cancers which includes DIPG. The data showed
strong synergy between the two agents, and points to further
research in this area.
- A poster presentation by Dr Michael
Paillasse and colleagues at Evotec SE describes some of the
novel biomarker selection strategies employed in the ongoing phase
I study of EVT801 in advanced solid cancers (NCT05114668). The
poster outlines the approaches taken by the Evotec team to identify
VEGFR3 expression in a range of tissues, potentially allowing for
the selection of clinical trial patients who are likely to be more
responsive to EVT801.
"The broad range of abstracts presented at AACR speak to the
breadth of work that is ongoing across our pipeline," said Dr
James Garner, Chief Executive
Officer of Kazia. "The promising new data from Professors Holmen
and Rubens, in melanoma and childhood brain cancer respectively,
reinforces the significance of these new opportunities for
paxalisib. Moreover, Kazia's ongoing collaboration with Evotec
remains extremely fruitful, with excellent work from the biomarker
team opening the possibility of rational patient selection in
clinical trials. Of note, biomarker strategy is an important area
of focus for FDA, and drug candidates with biomarker selection are
potentially more likely to achieve approval than those
without."
Summary of Abstracts
SESSION PO.ET03.02 – Drug Resistance in Molecular Targeted
Therapies 2
April 16, 2023 – 1:30pm-5:00pm
Abstract 427/22 – Newer generation mTOR inhibition
represents effective therapeutic strategy for BRAF-mutant
melanoma
Gennie L Parkman, Tursun Turapov, David
Kircher, William Burnett,
Christopher Stehn, Kayla O'Toole, Katie
Culver, Ashley Chadwick,
Riley Elmer, Ryan Flaherty, Mona
Foth, Karly Stanley,
Robert Andtbacka, David Lum, Robert
Judson-Torres, Martin
McMahon, Sheri Holmen
Huntsman Cancer Institute, University of
Utah, Salt Lake City,
UT
University of Minnesota,
Minneapolis, MN
SESSION PO.CL09.01 – Combination Therapies for Cancer
April 18, 2023 – 1:30pm-5:00pm
Abstract 5490/8 – Combination of the PI3k inhibitor
paxalisib with the nucleoside analog Gemcitabine over-activates the
integrated stress response and induces atypical teratoid / rhabdoid
tumor cell death
Tyler Findlay, Kristen
Malebranche, Anupa Geethadevi, Eric
Raabe, Charles Eberhart,
Jeffrey Rubens
Johns Hopkins University School of
Medicine, Baltimore,
MD
Abstract 5509/27 – The PI3K inhibitor paxalisib
combines synergistically with the MEK inhibitor mirdametinib to
target atypical teratoid / rhabdoid tumors
Kristen J. Malebranche, Tyler
Findlay, Anupa Geethadevi, Charles
Eberhart, Eric Raabe,
Jeffrey Rubens
Johns Hopkins University School of
Medicine, Baltimore,
MD
SESSION PO.ET01.04 – Targeting Protein Kinases and Phosphatases
for Therapy 1
April 18, 2023 – 1:30pm-5:00pm
Abstract 4990/3 – Dual inhibitor of ACVR1 and MEK
1/2 E6201 and PI3K/mTOR inhibitor paxalisib synergistically inhibit
cell growth in DMG
Hyuk Jean Kwon, Abigail Tindall, Charles
Eberhart, Jeffrey Rubens,
Eric Raabe
Johns Hopkins University School of
Medicine, Baltimore,
MD
SESSION PO.CL01.06 – Diagnostic and Prognostic Biomarkers 1
April 16, 2023 – 1:30pm-5:00pm
Abstract 1015/25 – VEGFR-3 expression profiling by
histology to classify patient population for the selective VEGFR-3
inhibitor EVT801
Michael Paillasse, Pierre-Benoit
Ancey, Gaelle Badet,
Anne Gomez-Brouchet, Janik Selves,
Philippe Rochaix, Maxime
Battistella, Celeste Lebbe,
Philippe Cassier, Carlos Gomez-Roca, Jean-Pierre Delord, Mark
Whittaker, Lise Davenne, John
Friend, Michael Fitzgerald,
James Garner, Pierre Fons
Evotec SE, Toulouse, France
& Abingdon, UK
Institut Universitaire du Cancer
Toulouse Oncopole, Toulouse,
France,
Université de Paris Cité, AP-HP Hôpital
Saint Louis, Paris, France,
Centre Léon Bérard,
Lyon, France
Kazia
Therapeutics Ltd, Sydney,
Australia
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.
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. 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.
For More Information, Please Contact:-
Jane Lowe
IR Department
jane.lowe@irdepartment.com.au
Phone: +61 411 117 774
View original content to download
multimedia:https://www.prnewswire.com/news-releases/kazia-presents-new-data-for-paxalisib-and-evt801-at-aacr-annual-meeting-301788639.html
SOURCE Kazia Therapeutics Limited