SYDNEY, Sept. 23,
2024 /PRNewswire/ -- Kazia Therapeutics Limited
(NASDAQ: KZIA), an oncology-focused drug development company, is
pleased to announce the presentation of data highlighting promising
clinical activity of EVT801 in high grade serous (HGS) Ovarian
Cancer at the 15th Biennial Ovarian Cancer Research
Symposium, co-presented by American Association of Cancer Research
(AACR) and the Rivkin Center for Ovarian Cancer Research on
Saturday, September 21, 2024 in
Seattle Washington.
Dr. John Friend, CEO Kazia Therapeutics presented preliminary data
from a Phase 1 first-in-human clinical trial evaluating the safety
and tolerability of EVT801, a highly selective small molecule
VEGFR3 inhibitor targeting tumour angiogenesis. The Phase 1 study
met its primary objectives, with the maximal tolerated dose
identified at 500mg twice a day (BID). The Phase 1 study also
identified the recommended Phase 2 dose starting at 400mg BID. It
was observed that EVT801 was tolerated across all doses, with the
majority of toxicities being mild to moderate and transient in
nature.
Key points of the presentation included:
- A total of 26 patients were treated across 6 dosing cohorts
ranging from 50mg once daily (QD) to 500mg twice daily (BID)
- Patients with eleven different cancer types (ex. colon, renal
cell, pancreatic) were enrolled in the study, with heavily
pretreated advanced ovarian cancer being the most prevalent
indication (11 patients)
- Biomarkers have shown strong VEGFR3 expression in multiple
indications, including ovarian cancer
- Encouraging clinical activity in High Grade Serous ovarian
cancer patients with forty-six percent (46%) having stable disease
or for at least three cycles, including two patients who received 9
cycles
- One patient had a partial response (-39% decrease) after 2
cycles of EVT801 therapy
Dr John Friend, CEO of
Kazia Therapeutics, commented: "I was honored to participate at
the Ovarian Cancer Research Symposium and present our findings to
fellow clinicians and ovarian cancer researchers from around the
globe. Ovarian cancer is often diagnosed at late stages with poor
patient prognosis, so the data from the Phase 1 study is extremely
encouraging and gives us confidence that we could potentially have
a first-in-class VEGFR-3 inhibitor with EVT801."
Abstract: Phase I study of EVT801, a VEGFR-3 inhibitor, shows
promising clinical activity in HGS ovarian
cancer
https://www.xcdsystem.com/rivkin/program/ZR7NvO4/index.cfm?pgid=1697
September 21, 2024 – 11:30am-1:30pm
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 been
completed with presentation of paxalisib arm data expected later in
2024 at a major medical conference. Other clinical trials involving
paxalisib are ongoing in brain metastases, diffuse midline gliomas,
and primary CNS lymphoma, with several of these trials having
reported encouraging interim data.
Paxalisib was granted Orphan Drug Designation for glioblastoma
by the FDA in February 2018, and Fast Track Designation (FTD)
for glioblastoma by the FDA in August 2020. Paxalisib was also
granted FTD in July 2023 for the treatment of solid
tumour brain metastases harboring PI3K pathway mutations in
combination with radiation therapy. In addition, 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.
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 evidence of synergy with
immuno-oncology agents. A Phase I study has been completed and
preliminary data was presented at 15th Biennial Ovarian Cancer
Research Symposium in September
2024.
For more information, please
visit www.kaziatherapeutics.com or follow us on X
@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, Kazia's strategy and plans
with respect to its programs, including paxalisib and EVT801, the
potential benefits of EVT801 as a VEGFR3 inhibitor and the
potential market opportunity for 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
SEC, and in subsequent filings with the United States Securities
and Exchange Commission. 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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