SYDNEY, Oct. 23,
2023 /PRNewswire/ -- Kazia Therapeutics Limited
(NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development
company, announces that selected clinical data from the company's
ongoing Phase 1 clinical trial evaluating EVT801 in patients with
advanced solid tumours was presented at the European Society of
Medical Oncology Congress 2023 (ESMO 2023) on Saturday,
21 October 2023.
Professor Carlos A Gomez-Roca, (IUCT-Oncopole, Toulouse France) presented data from a
correlation analysis of tumour biopsies from six (6) enrolled
patients with high grade serous ovarian cancer (HGS-OC). To date,
twenty (20) patients with advanced solid tumors have been dosed in
in the ongoing Phase 1 clinical trial, and the trial has advanced
to dose escalation cohort 6.
Key Points from the presentation:
- The hypothesis for EVT801's mechanism of action involves three
(3) sequential anti-cancer mechanisms, all of which are thought to
contribute to the potential inhibition of tumour growth and
metastasis:
- Preventing tumour growth by impairing both tumour angiogenesis
and (lymph)angiogenesis, thereby stabilizing the tumour
vasculature, reducing metastasis, and reducing hypoxia in the
tumour microenvironment.
- Enhancing anti-cancer immunity as reflected by a decrease in
immunosuppressive cytokines and cells in the circulation and tumour
environment.
- Promoting T-cell infiltration into the tumour, ultimately
supporting an enhanced and long-lasting anti-tumour immune
response.
- In a data analysis of biopsies from six (6) HGS-OC
patients, high levels of VEGFR3 expression tended to be correlated
with the following:
- Higher levels of hypoxia;
- Increased immune checkpoint (PD1) resistance; and
- Negatively correlated with CD8 positive T-cells
infiltration.
- While these findings would need to be confirmed in patients in
other indications, these correlations are encouraging and suggest
that patients with hypoxic HGS-OC tumours that are poorly
infiltrated with CD8 positive T-cells and with high VEGFR3
expression may benefit from EVT801 treatment.
"In spite of recent advances in treatments for ovarian cancer,
there is an extremely high rate of recurrence. The success of
immune checkpoint inhibitors in other solid tumours has not carried
through to high grade serous ovarian cancer. In data previously
presented at AACR 2023, we demonstrated a high prevalence of
VEGFR-3 expression in HGS-OC tumours, and we have now presented
data showing a positive correlation between VEGFR-3 expression and
hypoxia and PD1 resistance signature and a negative correlation
with CD8 positive T-cell infiltration," said Dr. John Friend, Chief Executive Officer of Kazia.
"We look forward to completing dose escalation in stage 1 of the
ongoing study and progressing to stage 2 of the Phase 1 Study
."
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 2 study
in glioblastoma reported promising signals of clinical
activity in 2021, and a pivotal study, 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
Food and Drug Administration (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 evidence of synergy with immuno-oncology agents. A Phase 1
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 and 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.
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SOURCE Kazia Therapeutics Limited