SYDNEY,
Sept. 12,
2024 /PRNewswire/ -- Kazia Therapeutics Limited
(NASDAQ: KZIA), an oncology-focused drug development company, is
pleased to announce that an agreement has been executed with QIMR
Berghofer Medical Research Institute, one of Australia's foremost cancer research centres,
to obtain an exclusive license to certain intellectual property
rights in relation to combination therapies consisting of PI3K
inhibitor drugs, and one or more immunotherapy or PARP inhibitor
drugs (PI3K combination).
Under the license agreement, Kazia receives an
exclusive, worldwide, sub-licensable and royalty-bearing licence to
certain intellectual property for the development of any drugs or
product candidates within the PI3K inhibitor class in combination
with immunotherapy or PARP inhibitors. Paxalisib, Kazia's lead
product candidate, is a member of the PI3K inhibitor class.
The exclusive license agreement follows a
collaboration between Kazia and QIMR Berghofer which began in
December 2022 and has already led to
the filing of supportive patents which include the use of paxalisib
as an immune modulator in the treatment of diseases such as breast
cancer.
The terms of the license include standard
provisions for an upfront license fee and development milestones
related to the initiation of Phase 1, Phase 2 trial, first Phase 3
trial, first product approval.
Commenting on the new license agreement, Kazia
CEO, Dr John Friend said: "This is
an exciting evolution in our partnership with QIMR Berghofer and an
important milestone for not only Kazia's development of paxalisib,
but also the company's commercial portfolio as we secure the
licence of a significant cancer immunotherapy pathway. We are very
pleased to have obtained the potential intellectual property rights
around PI3K inhibitors, which is a significant step forward as we
continue to explore cancer treatments beyond the brain, including
novel therapeutics in solid tumours such as breast cancer."
Professor Fabienne
Mackay, Director and CEO of QIMR Berghofer said: "We are
pleased to enter this exclusive licence agreement with Kazia
following what has been a successful research collaboration over
the past two years. We look forward to progressing the clinical
development pathway for PI3K inhibitor drugs such as paxalisib
under this partnership in the hope of delivering tangible,
life-changing benefits to patients."
Kazia's preclinical research collaboration with
QIMR Berghofer Medical Research Institute is investigating the use
of paxalisib in solid tumours. The ongoing research project is led
by Professor Sudha Rao, a leading
expert in transcriptional biology, particularly as it applies to
the function of the immune system in cancer. Prof Rao is the
principal investigator of preclinical studies where paxalisib and
KEYTRUDA® combination is used in Triple Negative Breast Cancer, and
paxalisib and LYNPARZA® (Olaparib) combination in advanced breast
cancer.
Professor Rao's team has demonstrated in
preclinical studies that the combination of paxalisib with
checkpoint inhibitor blockade resulted in highly consistent and
statistically significant signals of efficacy including overall
tumour volume, metastases, and inflammatory markers. Furthermore,
the addition of paxalisib to immunotherapy was observed to
reinvigorate the immune cells within the tumour microenvironment by
restoring immune killing function while inhibiting "pro-tumour"
immune cells. Further data is expected to be presented at future
scientific meetings in 2025.
Commenting on the research, Prof Rao said: "The
immune system plays a critical role in fighting against cancer. We
urgently need treatments that can make cancer cells visible, and at
the same time increase the utility of immunotherapy for metastatic
breast cancers. In that sense, paxalisib is an exciting PI3K
inhibitor because it not only has been observed to inhibit primary
tumour burden but was also observed to reinvigorate the immune
system of cancer patients. We look forward to providing a
preliminary update in the near future on our findings of using
paxalisib in breast cancer."
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 presentation of preliminary
data at a medical conference is anticipated in CY2024.
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 and investigator-initiated
trials of Kazia's product candidates, the potential benefits of
Kazia's product candidates, including paxalisib, 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,
risks related to collaborations with third parties, 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 United States Securities and Exchange
Commission (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.
This announcement was authorized for release by
Dr John Friend, CEO.
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SOURCE Kazia Therapeutics Limited