SYDNEY,
June 30, 2021
/PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX:
KZA), an oncology-focused drug development company, is pleased to
provide an update on recent progress with its two pipeline assets,
paxalisib and EVT801.
Key Points
- GBM AGILE pivotal study of paxalisib is recruiting ahead of
expectations, with almost 25 sites now open to the paxalisib
arm.
- Paxalisib phase II study in newly diagnosed glioblastoma has
seen the final patient complete drug treatment; a number of
patients remain in follow-up.
- EVT801 phase I study protocol has been submitted to the French
regulatory agency for review.
Kazia CEO, Dr James Garner,
commented, "Kazia has seen an exceptionally busy first half, with
excellent progress across our clinical programs. In particular, the
GBM AGILE study is performing ahead of our forecasts in terms of
recruitment. As we move into the second half of the year, we
anticipate conclusion of the paxalisib phase II study, initial data
readouts from a number of the paxalisib investigator-initiated
studies in other forms of brain cancer, and commencement of the
first-in-human phase I study of EVT801."
GBM AGILE
Almost twenty-five sites are currently open to the paxalisib arm
in the United States. The list
includes prestigious centres such as Memorial Sloan Kettering
Cancer Center, Henry Ford Cancer Institute, Columbia University Irving Cancer Research Center,
Emory University Winship Cancer
Institute, and the University of
Florida. The first site in Canada is expected to open in August 2021, followed by the first European sites
in Q4 CY2021.
To date, GBM AGILE has screened over 650 patients. This progress
is expected to accelerate as new sites in new territories come on
stream.
GBM AGILE is an international platform study design to identify
effective therapies for glioblastoma. It is an adaptive study, that
evaluates multiple therapies in parallel, and recruits only the
number of patients needed in each arm to reach a definitive answer.
With its innovative design and efficient operational
infrastructure, GBM AGILE is faster and more cost-effective than
conventional company-sponsored approaches, and data from GBM AGILE
may be used as the foundation of a new drug application to FDA and
other regulatory agencies. GBM AGILE has been designed and
implemented by the Global Coalition for Adaptive Research, a
world-leading consortium focused on adaptive clinical trials.
To date, three experimental therapies have joined GBM AGILE:
Bayer's regorafenib, Kazia's paxalisib, and Kintara Therapeutics'
VAL-083. It is expected that paxalisib will recruit up to 200
patients in the study, with the actual number determined by
emergent data from the study.
Kazia has brought forward the manufacture of an additional batch
of paxalisib investigational product, and this is expected to be
released for use in the study during early 4Q CY2021.
Paxalisib Phase II Study
The final patient in the paxalisib phase II study has
experienced disease progression after approximately 2.3 years on
treatment. A number of patients remain in follow-up and the study
is expected to conclude in 2H CY2021. Kazia anticipates no further
interim analyses at this stage, and instead expects to release
final data once the necessary analyses are complete.
Paxalisib Investigator-Initiated Studies
Kazia has been advised of generally good progress across the
ongoing investigator-initiated studies of paxalisib in other forms
of brain cancer. As previously indicated, the company expects that
the respective investigators will release initial data from several
of these studies during CY2021.
EVT801 Phase I Study
The study protocol for a planned phase I study of EVT801 has
been submitted to ANSM, the French regulatory agency. Kazia expects
to receive feedback from the agency late in 3Q CY2021.
The initial batch of EVT801 investigational product has been
manufactured and is ready for use. Two leading academic research
hospitals in France have been
selected as the initial trial sites, with the potential to expand
to additional sites as the study progresses.
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
glioblastoma, the most common and most aggressive form of primary
brain cancer in adults. Licensed from Genentech in late 2016,
paxalisib commenced recruitment to GBM AGILE, a pivotal study in
glioblastoma, in January 2021. Eight
additional studies are active in various forms of brain cancer.
Paxalisib was granted Orphan Drug Designation for glioblastoma by
the 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.
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
compelling evidence of synergy with immuno-oncology agents. A phase
I study is expected to begin in CY2021.
For more information, please visit www.kaziatherapeutics.com or
follow us on Twitter @KaziaTx.
This document was authorized for release to the ASX by
James Garner, Chief Executive
Officer, Managing Director.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/kazia-provides-progress-update-on-paxalisib-and-evt801-clinical-programs-301322699.html
SOURCE Kazia Therapeutics Limited