SYDNEY, Jan. 30,
2025 /PRNewswire/ -- Kazia Therapeutics Limited
(NASDAQ: KZIA) an oncology-focused drug development company,
is pleased to announce the regulatory approval and launch of a
clinical trial evaluating the combination of paxalisib and
immunotherapy in patients with advanced breast cancer. This novel
treatment combination offers what is believed to be a unique
approach to targeting this highly aggressive and
treatment-resistant type of breast cancer.
The ABC-Pax (Advanced Breast Cancer – Paxalisib) study is the
first known trial conducted to assess the safety and efficacy of
paxalisib in combination with KEYTRUDA® (pembrolizumab)
or LYNPARZA® (olaparib) in women with triple negative
breast cancer. ABC-Pax is a multi-centre, open-label phase
1b study that will enroll 24 patients
from top cancer centres in Queensland,
Australia and patients will receive the combination therapy
for up to 12 months.
The ABC-Pax study stems from pivotal research led by QIMR
Berghofer scientists in collaboration with Kazia Therapeutics,
which combined its drug candidate, paxalisib, with immunotherapy in
pre-clinical models. The team discovered that this combination
approach triggers a novel molecular program by epigenetic
re-programming of dormant cancer cells, making them visible to the
immune system, while also reinvigorating the immune cells to fight
the tumour cells. These new preclinical data were presented at San
Antonio Breast Cancer Symposium on December
12, 2024, and highlight the potential therapeutic synergies
between paxalisib and checkpoint inhibitor pembrolizumab
(KEYTRUDA®), as well as between paxalisib and poly (ADP-ribose)
polymerase inhibitor olaparib (LYNPARZA®), when used in combination
in a preclinical model of immunotherapy-resistant triple negative
breast cancer. The clinical trial is open for enrollment at the
Royal Brisbane and Women's Hospital and plans to expand to other
sites in Australia.
Kazia Therapeutics CEO, Dr John
Friend, said the novel combination treatment may have the
potential to transform the treatment of triple-negative breast
cancer and other aggressive tumour types.
"The novelty of the science that Professor Rao has proposed with
this dual combination of paxalisib and immunotherapy could advance
the treatment of women with aggressive breast cancer, and we are
excited to support this unique clinical study," Dr John Friend, CEO Kazia
Therapeutics said.
QIMR Berghofer's Professor Sudha
Rao said, "There is no cure for triple negative breast
cancer and the life expectancy for these women is tragically short.
We want to identify treatments to extend the duration and quality
of life of these patients. The hope is to prolong patient survival
through the new combined therapy, which targets the dormant cancer
cells that drive the spread and recurrence of the disease and
rejuvenates the immune system to more effectively fight the
cancer."
The ABC-Pax trial will also evaluate a non-invasive liquid
biopsy digital pathology platform developed by Professor Rao and
her team, which can monitor the behaviour of cancer cells and
immune cells in real time from a blood sample.
"By regularly analysing blood samples from trial participants
using our liquid biopsy digital pathology platform, we can track
the effectiveness of the treatment in real time. We believe this
approach represents a major advance in precision medicine by
offering a faster and more accurate way to monitor patient
progress," Professor Rao said.
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 2/3 study in glioblastoma (GBM-Agile) was reported
in 2024 and discussions are ongoing for designing and executing a
pivotal registrational study in pursuit of a standard approval.
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 ABC-Pax study and the
potential results of combination studies of paxalisib, the
potential benefits of paxalisib as an investigational PI3K/mTOR
inhibitor, timing for any regulatory submissions or discussions
with regulatory agencies, and the potential market opportunity for
paxalisib. 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/kazia-therapeutics-announces-the-launch-of-a-groundbreaking-trial-with-paxalisib-in-combination-with-immunotherapy-in-women-with-advanced-breast-cancer-302364230.html
SOURCE Kazia Therapeutics Limited