Ann: Presentations at upcoming scientific meetings, page-5

KAZIA THERAPEUTICS
ANNOUNCES CLINICAL DATA AT
ESMO 2023 FROM ONGOING
PHASE 1 EVT801 STUDY
NEWS PROVIDED BY
Kazia Therapeutics Limited
23 Oct, 2023, 07:01 ET

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 anticancer 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 Tcell 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 immunooncology 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 forwardlooking statements, which apply only as of the date of this announcement.
SOURCE Kazia Therapeutics Limited