SYDNEY, Oct. 27,
2022 /PRNewswire/ -- Kazia Therapeutics Limited
(NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development
company, is pleased to announce the presentation of new data from
an ongoing research collaboration with the Huntsman Cancer
Institute at the University of Utah in
Salt Lake City, UT.
A poster presentation by Dr Gennie
Parkman and colleagues, working in the laboratory of
Professor Sheri Holmen, has shown
paxalisib to be active in vitro and in vivo against a
range of preclinical models of metastatic melanoma, the most
aggressive form of skin cancer. Dr Parkman's data suggested
substantial activity for paxalisib as monotherapy, and greater
activity in combination with MEK and BRAF inhibitors, two classes
of drugs that are commonly used for a substantial proportion of
melanoma patients.
"This is among the most promising single agent data that we have
seen in our research," commented Professor Sheri Holmen, lead investigator on the project.
"Despite the widespread adoption of immunotherapy in recent years,
there remains substantial unmet need in melanoma, particularly in
those patients who develop brain metastases. We look forward to
exploring the potential of paxalisib further in our research, and
hopefully seeing the drug transition to a clinical trial in the
near future."
A copy of Dr Parkman's poster is available via the Kazia
website.
The research by the University of
Utah team was presented at the 19th International
Congress of the Society for Melanoma Research, held in Edinburgh, Scotland from October 17th – 20th, 2022.
The collaboration remains ongoing, with additional preclinical
studies anticipated as a prelude to potential future clinical
trials.
Key Points
- Approximately 100,000 Americans are diagnosed with invasive
melanoma each year. It is the fifth most common cancer in the US,
and one of the most common cancers in young adults. Despite marked
progress in treatment of the disease, around 7,500 patients die
from melanoma in the US each year.
- Approximately 50% of melanoma cases harbor a genetic mutation
known as BRAF. Such patients are often treated with a combination
of two drugs, known as a MEK inhibitor and a BRAF inhibitor
respectively.
- Despite receiving BRAF / MEK inhibitor therapy, most patients
eventually progress. Activation of the PI3K / Akt / mTOR pathway,
which is the target of paxalisib, has been identified as a key
resistance mechanism to these therapies, and has also been found to
promote brain metastases.
"We are honored to be collaborating with Professor Holmen's team
at the Huntsman Cancer Institute," commented Dr James Garner, Chief Executive Officer at Kazia.
"Although brain cancer, in various forms, has been the primary
focus of paxalisib's clinical development thus far, we have always
believed that the drug offers the potential to treat cancers that
metastasize to the brain, and indeed cancers outside the central
nervous system. This promising data from one of the leading US
melanoma research centers points towards an important new
opportunity for paxalisib. We look forward to working closely with
the team to move this collaboration forward."
Melanoma
Approximately 1 in 50 people will be diagnosed with melanoma
during their lifetime. Most cases are localized to the skin and can
be cured through surgical resection. However, about 20% of cases
spread (metastasize) and require more complex and ongoing
treatment.
Melanoma represents approximately 1% of all skin cancers, but
accounts for the majority of deaths from skin cancer. For melanoma
that is confined to the skin at the time of diagnosis, the
five-year survival rate is 99.5%. However, for melanoma that has
spread to distant sites (metastatic melanoma), the five-year
survival rate falls to 32%.
Approximately 50% of patients harbour activating mutations in
the BRAF gene. Such patients are typically treated with the
combination of a BRAF inhibitor and a MEK inhibitor. The most
common drugs used are Tafinlar® (dabrafenib) / Mekinist®
(trametinib) (manufactured by Novartis), Braftovi® (encorafenib) /
Mektovi® (binimetinib) (manufactured by Pfizer), and Zalboraf®
(vemurafenib) / Cotellic® (cobimetinib) (manufactured by
Genentech). The introduction of such targeted therapies has
improved the average survival of patients with BRAF-mutant
metastatic melanoma from approximately 6 months to approximately 24
months. However, there remains a need for additional therapeutic
options to further improve survival.
Next Steps
Kazia anticipates further data from the ongoing collaboration
with the Huntsman Cancer Institute in CY2023. Depending on the
results, Kazia may evaluate future opportunities to launch a
clinical trial of paxalisib in melanoma.
A broad clinical program exploring paxalisib in multiple forms
of brain cancer is ongoing. During 2022, two ongoing clinical
trials of paxalisib in the treatment of brain metastases have
reported positive interim results and have graduated to expansion
cohorts.
In addition, six other clinical trials of paxalisib in other
forms of adult and pediatric brain cancer are ongoing, with
multiple data read-outs anticipated throughout 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.
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.
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SOURCE Kazia Therapeutics Limited