SYDNEY, March 21,
2024 /PRNewswire/ -- Kazia Therapeutics Limited
(NASDAQ: KZIA), a biotechnology company specialising in oncology,
is pleased to announce that it has entered into an exclusive
licensing agreement with Sovargen Co., Ltd, a biotechnology company
specializing in central nervous system (CNS) diseases, to
develop, manufacture and commercialise paxalisib as a potential
treatment of intractable epilepsy in focal cortical dysplasia type
2 (FCD T2) and tuberous sclerosis complex (TSC) disease. The
underlying cause of FCD T2 and TSC can be traced back to somatic
mutations in the PI3K/Akt/mTOR pathway or mutations in the TSC1 or
TSC2 genes, which lead to the overactivation of the mTOR pathway.
Paxalisib is an oral dual inhibitor targeting both PI3K and mTOR
within this pathway, and it is distinguished by its ability to
penetrate the brain. Although FCD T2 and TSC are rare orphan
diseases, they represent a high medical unmet need with significant
market opportunity. There are currently no approved drugs for
patients with FCD T2.
Under the agreement, Kazia will receive an upfront payment of
US$1.5 million, potential milestone
payments of up to US$19 million upon
the achievement of development and regulatory milestones, and a
percentage of sub-licensing revenues and royalties on net sales of
products incorporating paxalisib. The licensing agreement includes
all countries worldwide, excluding mainland China, Hong
Kong, Macao and
Taiwan, which Kazia retains.
Kazia CEO Dr. John Friend said:
"We are pleased to announce we have exclusively licensed the
development, manufacture and commercialization of paxalisib to
Sovargen for its potential use in select CNS diseases that are
associated with mTORopathy. Kazia's primary focus of paxalisib
continues to be oncology, with multiple studies ongoing. Our
license with Sovargen provides us the ability to explore the impact
of paxalisib outside of our area of expertise where there is
substantial patient need and market opportunity. We are
enthusiastic about seeing paxalisib's potential explored in these
patient populations."
Sovargen CEO Cheolwon Park shared his excitement about the
collaboration: "The dual inhibition mechanism of paxalisib, coupled
with its observed safety profile from previous oncology studies,
positions us to anticipate initiation of a Phase 2 clinical trial
for patients with FCD T2 and TSC in the latter half of 2024.
Sovargen has played a pioneering role in identifying the critical
link between mTOR hyperactivation due to mTORopathy somatic
mutations and epileptic seizures in FCD T2 patients and we have an
unwavering dedication to developing effective treatments for these
patients."
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, is
ongoing, with final data expected in 1H2024. 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 FDA in February 2018, and 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 is
ongoing and preliminary data is anticipated in CY2024.
For more information, please visit www.kaziatherapeutics.com or
follow us on Twitter @KaziaTx.
About Sovargen
Sovargen Co., Ltd. is a biotechnology company focused on the
discovery and development of drugs to treat rare and incurable
neurological disorders that are caused by brain somatic
mosaicism.
Sovargen's platform technology is associated with ASO (Antisense
Oligonucleotide) development for undruggable targets in CNS disease
including technology for target discovery (SovarIN™), ASO drug
discovery & optimization (SovarON™), and target validation
& efficacy evaluation platform using disease-specific animal
model and human organoid system (SovarUP™).
For more information, please visit www.sovargen.com
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: expansion of paxalisib into other indications
including intractable epilepsy in focal cortical dysplasia
type 2 (FCD T2) and tuberous sclerosis complex (TSC) disease,
expectations regarding whether milestones will be met, expectations
on market opportunities for paxalisib in FCD T2 and TSC, plans to
initiate clinical trials for paxalisib in FCD T2 and TSC, the
timing for results and data related to Kazia's clinical and
preclinical trials and investigator-initiated trials of Kazia's
product candidates, 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
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
