SYDNEY, Nov. 29,
2023 /PRNewswire/ -- Kazia Therapeutics Limited
(NASDAQ: KZIA), an oncology-focused drug development company, is
pleased to announce that it has signed a non-binding Letter of
Intent (LOI) with an undisclosed biotechnology company for the
license of worldwide rights, other than mainland China, Hong
Kong, Macao and
Taiwan, to develop and
commercialize pharmaceutical product containing paxalisib in an
indication outside of cancer.
Mutual due diligence has been completed and each company has
agreed to move forward to negotiate and use their best efforts to
agree to the terms of a definitive agreement. The LOI sets out the
proposed terms and preliminary conditions of the agreement as well
as a 90-day exclusivity period. The proposed terms include an
upfront payment, and potential for clinical and regulatory
milestone payments, as well as commercial sales-based royalties and
milestones. The companies are currently negotiating the definitive
license agreement. There can be no assurance that a
definitive license agreement will be executed or that the proposed
transaction will be consummated on the terms or timeframe currently
contemplated.
"As we continue to pursue the potential benefits of paxalisib in
patients with cancer, this strategic alliance would assist to
develop paxalisib to address a significant unmet medical need
outside of oncology," said Kazia CEO Dr. John Friend. "This alliance would leverage our
strengths as well as those of our partner to benefit patients,
families and our stakeholders. Relevant details of the final
definitive license agreement will be subject to mutual agreement of
the parties, our Board of Directors' approval and disclosed
thereafter."
This announcement was authorized for release by Dr. John Friend, CEO.
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, 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 II 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, DMGs, 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 tumors 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 tumor types and has provided
evidence of synergy with immuno-oncology agents. A Phase I study in
advanced solid tumors 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:
expectations regarding the entry into a definitive agreement, the
timing with respect thereto and expectations regarding financial
and other terms and whether milestones will be met. 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, including the risk that preliminary or interim data
may not reflect final results, 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 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/kazia-announces-non-binding-letter-of-intent-for-the-proposed-granting-of-rights-to-develop-and-commercialize-paxalisib-outside-of-oncology-302000146.html
SOURCE Kazia Therapeutics Limited